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SPECIAL CONTRIBUTION
ANEVIDENCE-BASED PREHOSPITAL GUIDELINE FOR EXTERNAL HEMORRHAGE
CONTROL:AMERICAN COLLEGE OF SURGEONS COMMITTEE ON TRAUMA
Eileen M. Bulger, MD, FACS, David Snyder, PhD, Karen Schoelles, MD, FACP,
Cathy Gotschall, ScD, Drew Dawson, BA, Eddy Lang, MD, CM CCFP (EM) CSPQ, Nels
D. Sanddal, PhD, NREMT, Frank K. Butler, MD, FAAO, FUHM, Mary Fallat, MD, FACS,
Peter Taillac, MD, Lynn White, MS, CCRP, Jeffrey P. Salomone, MD, FACS, NREMT-P,
William Seifarth, MS, NREMT-P, Michael J. Betzner, MD, FRCPC, Jay Johannigman, MD,
FACS,NormanMcSwain,Jr.,MD,FACS,NREMT-P
Received January 21, 2014 from the University of Washington,
Seattle, Washington (EB), ECRI Institute of Health Technology
Assessment, Washington DC (DS, KS), Office of Emergency Medical
Services National Highway Traffic Safety Administration, Wash-
ington DC (CG, DD), University of Calgary, Alberta, Canada (EL,
MJB), American College of Surgeons, Chicago, IL (NDS), Committee
on Tactical Combat Casualty Care, Joint Trauma System (FKB),
University of Louisville, Louisville, Kentucky (MF), University of
Utah,SaltLakeCity,Utah(PT),AmericanMedicalResponse,Inc.
(LW), Maricopa Medical Center, Phoenix, Arizona (JPS), Department
of Homeland Security, Office of Health Affairs (WS), University of
Cincinnati, Cincinnati, Ohio (JJ), and Tulane School of Medicine,
New Orleans, Louisiana (NM). Revision received February 12, 2014;
accepted for publication February 13, 2014.
The systematic review of the evidence used for the development
of these guidelines was conducted by ECRI Institute with funding
provided by the National Highway Traffic Safety Administration,
DTNH22-11-C-00223.
This publication was developed in part with funding from the Na-
tional Highway Traffic Safety Administration (NHTSA) of the U.S.
Department of Transportation (DOT). The opinions, findings and
conclusions expressed in this publication are those of the authors
and not necessarily those of NHTSA or DOT. The United States Gov-
ernment assumes no liability for its content or use thereof. If trade or
manufacturer’s names or products are mentioned, it is because they
are considered essential to the object of the publication and should
not be construed as an endorsement. The United States Government
does not endorse products or manufacturers.
The opinions or assertions contained herein are the private views of
the authors and are not to be construed as official or as reflecting the
views of the Department of the Army or the Department of Defense.
The authors report no conflicts of interest. The authors alone are re-
sponsible for the content and writing of the paper.
Address correspondence to Eileen M. Bulger, MD, Professor of
Surgery, Chief of Trauma, Box 359796, Harborview Medical Center,
325 9th Avenue, Seattle, WA 98104, USA. E-mail: ebulger@uw.edu
doi: 10.3109/10903127.2014.896962
ABSTRACT
This report describes the development of an evidence-based
guideline for external hemorrhage control in the prehospital
setting. This project included a systematic review of the liter-
ature regarding the use of tourniquets and hemostatic agents
for management of life-threatening extremity and junctional
hemorrhage. Using the GRADE methodology to define the
key clinical questions, an expert panel then reviewed the re-
sults of the literature review, established the quality of the
evidence and made recommendations for EMS care. A clini-
cal care guideline is proposed for adoption by EMS systems.
Key words: tourniquet; hemostatic agents; external hemor-
rhage
PREHOSPITAL EMERGENCY CARE 2014;18:163–173
INTRODUCTION
External hemorrhage has been increasingly recognized
as a major cause of potentially preventable death
following severe injury. This issue has been thor-
oughly addressed by the U.S. military Tactical Com-
bat Casualty Care Committee (TCCC) in response to
the increase in life-threatening external hemorrhage
seen in the conflicts in Iraq and Afghanistan (www.
health.mil/Education And Training/TCCC.aspx). Im-
plementation of the TCCC guidelines for tourniquet
use has been associated with a significant reduction
in the number of combat deaths attributed to ex-
tremity hemorrhage.1Lessons learned from the mil-
itary management of these injuries are beginning to
be adopted in the civilian community and the re-
cent Boston marathon bombing event highlighted this
issue.2A report from the National Trauma databank
suggests that mortality for patients with isolated lower
extremity trauma with an arterial injury is 2.8%, with a
6.5% amputation rate.3
163
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164 PREHOSPITAL EMERGENCY CARE APRIL/JUNE 2014 VOLUME 18 / NUMBER 2
The use of tourniquets and hemostatic agents in the
civilian EMS community is not widespread.4,5While
there is increasing interest in the use of these agents
by civilian EMS agencies, the differences between the
civilian and military populations may be important.
These considerations, not well addressed in the pub-
lished military experience, include the use of these
modalities in elderly and pediatric patients and the
impact of medical comorbidities on outcome. Even as
recently as 2011, the Guidelines for Field Triage of In-
jured Patients does not include a recommendation for
tourniquet use as a trauma triage criteria because “ev-
idence is limited regarding the use of tourniquets in
civilian populations; use of tourniquets among EMS
systems varies; inclusion of tourniquet use as a cri-
terion could lead to overuse of tourniquets instead
of basic hemorrhage control methods, and thus
potentially result in overtriage.”6However, the Na-
tional EMS Scope of Practice Model published in 2007
lists tourniquet use as part of the minimum psy-
chomotor skill set for emergency trauma care for emer-
gency medical technicians. In addition, tourniquets
have been included as required basic life support (BLS)
equipment in the Joint Policy Statement: Equipment
for Ambulances.7Topical hemostatic agents are listed
as optional basic equipment. The recent Hartford con-
sensus conference also encourages wider civilian use
of tourniquets for management of hemorrhage in ac-
tive shooter events.8
The purpose of this project was to develop evidence-
based guidelines for the use of tourniquets and
hemostatic dressings in the U.S. civilian prehospi-
tal setting. The recommendations were based on a
systematic review of the current literature and were
developed using the GRADE methodology.9External
hemorrhage is defined as blood loss originating from
a ruptured blood vessel and appearing on the body
surface. For the purposes of our review, this includes
extremity hemorrhage and junctional hemorrhage.
Junctional hemorrhage includes the groin proximal
to the inguinal ligament, the buttocks, the gluteal and
pelvic areas, the perineum, the axilla and shoulder
girdle, and the base of the neck.10
APPROACH
Expert Panel
An expert panel was convened by the American
College of Surgeons Committee on Trauma EMS
Committee to include nationally recognized experts
in prehospital trauma care. Representatives were
included from the military’s Tactical Casualty Combat
Care Committee, Prehospital Trauma Life Sup-
port, civilian State EMS directors, trauma surgeons,
emergency physicians, a pediatric surgeon, an EMS
researcher, a GRADE methodologist, and a paramedic.
Representatives were from both the United States and
Canada. Panelists provided input to the formulations
of the PICOTS (populations, interventions, compara-
tors, outcomes, timing, and settings) questions prior to
the initiation of the literature review. For the PICOTS
questions, the population of interest was defined
to be individuals with extremity hemorrhages; the
interventions were commercially available tourniquets
and hemostatic dressings; comparators were external
wound pressure and nontourniquet or nonhemostatic
interventions; outcomes of interest were limb salvage,
hypovolemic shock, survival, and adverse effects.
Because timing and setting were considered to be
key aspects of the investigation the PICO format was
expanded to include both immediate and long-term
outcomes and the setting for the intervention was
defined as the prehospital environment, before any
procedures are performed in the hospital emergency
department or operating theater. Following the com-
pletion of the systematic literature review, the panel
met to review the literature in a full day meeting
in Washington DC, October 2013. An expert in the
application of the GRADE methodology facilitated the
meeting and the panel used this approach to develop
recommendations for each PICOTS question.
Evidence Review
A systematic review of the literature was conducted
by the ECRI Institute, one of the eleven Evidenced-
Based Practice Centers designated by the U.S. Agency
for Healthcare Research and Quality. Their system-
atic literature review and evidence tables were used
by the expert panel to develop these recommenda-
tions. A summary of the findings is included in this
manuscript; the full ECRI report will be simulta-
neously published by the National Highway Traffic
Safety Administration (NHTSA) and will be available
at www.ems.gov. The PICOTS questions used to guide
the literature review were developed with input from
the multidisciplinary expert panel.
Literature search included 13 external and inter-
nal electronic databases, including CINAHL, EM-
BASE, and Medline, from 2001 to the present
for fully published, primary, clinical studies. The
Cochrane Database of Systematic Reviews (Cochrane
Reviews), Database of Abstracts of Reviews of Ef-
fects (DARE), and Health Technology Assessment and
Database (HTA) were also searched for secondary
reviews. Additional search steps included manual
search of bibliographies listed in fully published stud-
ies; search and written inquiry to regulatory agen-
cies, including the U.S. Food and Drug Administra-
tion; and search of www.ClinicalTrials.gov and www.
controlled-trials.com for ongoing clinical trials. Pub-
lications were also suggested for inclusion by expert
panel members who commented on the draft report.
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E. M. Bulger et al. PREHOSPITAL GUIDELINE FOR EXTERNAL HEMORRHAGE CONTROL 165
The criteria for inclusion in the systematic review
were studies published in English that reported on
traumatic hemorrhage treated by EMS personnel in
the prehospital setting with tourniquets or hemostatic
dressings currently available in U.S. commercial mar-
kets. In addition, the studies reported findings on at
least one of the outcomes identified in the PICOTS
questions and included at least 5 patients per treat-
ment group; results for extremity and junctional hem-
orrhage were considered separately. To avoid duplica-
tion, when several sequential reports from the same
study center were available, only findings from the
largest, most recent, or most complete report was
used. Because of the paucity of published studies on
hemostatic dressings, for these questions the inclusion
criteria were expanded to include animal studies of
FDA-cleared or approved hemostatic dressings using
either a swine or goat model of extremity bleeding.
Risk of bias and other indicators of strength of evi-
dence were assessed and reported.
The absolute risk differences and relative risk (RR)
with 95% confidence intervals for the primarily di-
chotomous outcomes were calculated for individual
studies. In cases in which meta-analyses was possible
a summary odds ratio (OR) was calculated using a
random effects model. Studies were combined using
meta-analysis when populations and interventions
were similar. Given the nature of the populations
examined in this report, military populations were
separated from civilian populations and data from
children (younger than 18 years of age) was also
examined independently. Statistical heterogeneity was
examined using
I
2, but the small number of studies in
the comparisons limited our confidence in measures
of heterogeneity.
PICOTS Questions
1) In trauma patients with extremity hemorrhage
(excludes junctional hemorrhage) who are treated
in the prehospital setting, what is the effect of
tourniquet use (single or double) with or without
external wound pressure on limb salvage, hypo-
volemic shock, survival, and adverse effects com-
pared with external pressure alone or with other
nontourniquet interventions?
2) In trauma patients with junctional hemorrhage
who are treated in the prehospital setting, what is
the effect of junctional hemorrhage control device
use with or without external wound pressure on
limb salvage, hypovolemic shock, survival, and
adverse effects compared with external pressure
alone.
3) In trauma patients with extremity hemorrhage
(excludes junctional hemorrhage) who are treated
in the prehospital setting, do different brands or
models of tourniquets differ from each other in
their effect on limb salvage, hypovolemic shock,
survival, and adverse effects?
4) In trauma patients with junctional hemorrhage
who are treated in the prehospital setting by EMS
personnel, do different brands or models of spe-
cialized junctional hemorrhage control devices
differ from each other in their effect on limb sal-
vage, hypovolemic shock, survival, and adverse
effects?
5) In trauma patients with external hemorrhage (ex-
cludes junctional hemorrhage) who are treated in
the prehospital setting using a tourniquet –
a) Does the incidence of adverse events vary
by the duration of tourniquet use prior to
removal?
b) Does the incidence of adverse events vary de-
pending on whether tourniquets are removed
in the field versus in a facility?
6) In trauma patients with external hemorrhage
(hemorrhage from any body surface) who are
treated in the prehospital setting, what is the ef-
fect of hemostatic dressings with or without ex-
ternal wound pressure on, control of hemorrhage,
limb salvage (if an extremity involved), hypov-
olemic shock, survival, and adverse effects com-
pared with using non-hemostatic gauze with or
without external wound pressure?
7) In trauma patients with external hemorrhage
(hemorrhage from any body surface) who are
treated in the prehospital setting, do different
brands or types of hemostatic dressings differ
from each other in their effect on, hemorrhage
control, limb salvage (if an extremity is involved),
hypovolemic shock, survival, and adverse ef-
fects?
GRADE Methodology
The panel used the Grading of Recommendations
Assessment, Development and Evaluation (GRADE)
methodology to guide the process of PICOTS ques-
tion formulation, evidence appraisal, and to desig-
nate the strength of recommendations. The process
also adhered to the National Prehospital Evidence-
Based Guideline (EBG) Model Process approved by
the Federal Interagency Council for EMS and the Na-
tional EMS Advisory Council.11,12 Panel members re-
ceived an introduction to the GRADE methodology
and reviewed the evidence for structured clinical ques-
tions using the PICO framework. After reading and
discussing the systematic review of the evidence, the
panel drafted graded recommendations. The recom-
mendations were graded strong or weak, based on the
balance between risk, benefit, burden, and cost, while
the quality of evidence was appraised as high, mod-
erate, low, or very low.13–18 Although the initial as-
signment of a strength of evidence rating is based on
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166 PREHOSPITAL EMERGENCY CARE APRIL/JUNE 2014 VOLUME 18 / NUMBER 2
study design, GRADE allows the evidence appraisal to
be upgraded or downgraded, depending on such fac-
tors as the size and consistency of the reported effect or
the presence of a dose response.19 Using the GRADE
terminology, strong recommendations begin with the
words “we recommend” and indicate that the panel
believes that the benefits clearly outweigh any risks
associated with the treatment and that nearly all in-
formed patients would want the recommended treat-
ment. Weak recommendations begin with the words
“we suggest,” which indicates that the panel had a
higher level of uncertainty about estimated benefits of
the treatment the balance between benefits and risks.
RESULTS
Summary of Evidence Review
Our searches identified 1,599 potential citations for
evaluation and full review identified 23 clinical studies
that met our inclusion criteria (Figure 1). While not the
focus of this review we also reviewed 39 animal model
studies, which compared efficacy of the topical hemo-
static agents. Nine studies were identified that used
only human volunteers and these were excluded.
Tourniquet Use
We identified 20 publications of prehospital tourniquet
use for trauma-induced extremity hemorrhage. How-
ever, four publications did not provide information on
outcomes needed for inclusion in this report: Lairet
et al.,20 Gerhardt et al.,21 Kragh et al.,22 Kragh et al.23 In
two instances, the same study population was assessed
in two separate publications. Kragh et al.24 and Kragh
et al.25 used the same set of 499 patients and Kragh
et al.26 and Kragh et al.27 used the same set of 232 pa-
tients. The 16 included publications are listed in Table 1
along with the setting in which the data on tourniquet
1599 Citations identified by literature searches
Titles screened 1116 Citations exclu ded
283 Full articles retrieved
Full articles
rev iew ed
127 Articles excluded plus 82 ba ckground
art icle s
23 clinical studies:
16 studies of tour niquets
7 clinical studies of hemostatic dressings
9 studies with human volunteers
3 simulation studies
39 Animal model studies
Abstracts
screened 200 Citations excluded
483 Cita tions for abstrac t screening
FIGURE 1. Summary of literature review.
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TABLE 1. Studies of prehospital tourniquet use
Reference Setting
Period of data
collection
N
Patient characteristics Outcomes reported
Eastridge et al., 20121U.S. military
Iraq/Afghanistan
Oct 2001 to
June 2011
976 Not reported Deaths
King et al., 201240 U.S. military
Afghanistan
Aug 2011 to
Nov 2011
54 Not reported Deaths, adverse events
Kragh et al., 201228 U.S. military
Iraq/Afghanistan
pediatric casualties
May 2003 to
Dec 2009
88 (pediatric) 72 were male and 16 were female patients.
Mean age was 11 years (median, 11 years;
range, 4–17 years). Injuries: explosion 64%,
gunshot 30%, other 6%.
Deaths
Kotwal et al., 201129 U.S. military
Iraq/Afghanistan
Oct 2001 to
March 2010
460
(66 w/tourniquet)
All casualties were male, with age at time of
injury ranging from 18.9 to 52.9 years.
Injuries: explosion 67%, gunshot 24%, blunt
trauma 6%.
Deaths, amputations
Kragh et al., 201125 U.S. military
Iraq
March 2006 to
March 2007
499 96% male, average age 29 years, 16 were
children and 5 elderly. Injury: explosion 75%.
Deaths, adverse events
Kragh et al., 201124 (same study
as Kragh et al., 201125 but
reporting morbidities)
U.S. military
Iraq
March 2006 to
March 2007
499 96% male, average age 29 years, 16 were
children and 5 elderly. Injury: explosion 75%.
Adverse events
Brown et al., 201041 U.K. military
Iraq/Afghanistan
Aug 2003 to
May 2008
23 Median age 26 years, range 18–42 years, not
specific to tourniquet patients. Injuries for
entire patient pool: explosion 62%, gunshot
38%.
Adverse events
Brodie et al., 200942 U.K. military
Iraq/Afghanistan
Feb 2003 to
Sept 2007
70 Gender and age data not reported. Injuries:
explosion 86%, gunshot 14%.
Deaths, amputations,
adverse events
Clasper et al., 200931 U.K. military
Iraq/Afghanistan
Dec 2003 to
May 20008
44
(22 w/tourniquet)
Tourniquet group: mean age of 26.6 years, range
19–37 years. Injuries: explosion 32%.
Nontourniquet group: mean age of 25.7 years,
range 19–37 years. Injuries: explosion 64%.
Amputations, adverse
events
Kragh et al., 200926
(reassessment of data from
Kragh et al., 200827)
U.S. military
Iraq
March to Oct
2006
232
(194 w/tourniquet)
95% male, mean age of 29 years, range
4–70 years, 9 children and 1 elderly. Injuries:
explosion 63%, gunshot 23%.
Deaths, amputations,
adverse events
Tien et al., 200943 Canadian military
Afghanistan
Feb 2006 to
May 2006
134?? Entire study examined 134 patients, 96% male,
mean age of 26 years. Injuries: explosion 34%,
gunshot 32%, blunt 22%.
Deaths
Beekley et al., 200830 U.S. military
Iraq
Jan 2004 to
Dec 2004
165 (67 w/
tourniquet)
Tourniquet group: 97% male, mean age of
29 years. Injuries: explosion 64%, gunshot
30%.
Nontourniquet group: 96% male, mean age of
25. Injuries: explosion 70%, gunshot 27%.
Deaths, amputations,
adverse events
Dayan et al., 200832 Israeli military 2006 5 (prolonged
tourniquet use)
All males, 20–22 years old. Injuries: explosion =
1, gunshot. =4.
Deaths, amputations,
adverse events
Kalish et al., 200844 U.S. civilian Jan 1999 to
April 2006
11 All males, mean age of 27 years, gunshot
wounds 55%, stab wounds 27%, lacerations
18%.
Deaths and adverse
events
Kragh et al., 200827 U.S. military
Iraq
March 2006 to
Oct 2006
232
(194 w/tourniquet)
95% male, mean age of 29 years, range
4–70 years, 9 children and 1 elderly. Injuries:
explosion 63%, gunshot 23%.
Deaths, amputations,
adverse events
Lakstein et al., 200333 Israeli military Jan 1997 to
Jan 2001
91 (improvised
tourniquets)
Gender and mean age not reported. Injuries:
explosion 73%, gunshot 27%.
Deaths, amputations,
adverse events
167
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168 PREHOSPITAL EMERGENCY CARE APRIL/JUNE 2014 VOLUME 18 / NUMBER 2
use were collected and the outcomes reported by each
study. The large majority of studies were conducted
by the U.S. military in Iraq and Afghanistan (8 stud-
ies) with 3 studies from the U.K. military, 2 from the
Israeli military, and 1 from Canadian military. Only 1
study was conducted in a civilian setting. One study
used data on pediatric casualties described in the Joint
Theater Trauma Registry and collected during the wars
in Iraq and Afghanistan.28 Thirteen of the 16 included
studies reported data on deaths, 11 reported data on
adverse events, 8 reported data on amputations, and
none reported data on shock.
Eight of the studies used prospective data collec-
tion. Most of the studies provided some information
on how the tourniquets were to be used, but only a
few were specific about the instructions. However, the
studies from the U.S. military were using TCCC prac-
tices when data were collected after 2005 and tourni-
quets were likely used aggressively as a first option for
traumatic extremity hemorrhage.
Comparisons between casualties treated with a
tourniquet and similar casualties not treated with a
tourniquet were attempted by only a few studies. Kot-
wal et al.29 reported the number of casualties treated
with compression dressings but did not report out-
comes for this group. Beekley et al.30 reported out-
come data for tourniquet- and nontourniquet-treated
casualties but did not report what prehospital treat-
ments the nontourniquet group received. Clasper
et al.31 matched surviving tourniquet-treated casual-
ties with surviving nontourniquet-treated casualties
to examine the rate of adverse events. These au-
thors note, however, that “in a standard retrospec-
tive study it is likely that there would be consider-
able bias if simple comparison was made between the
two groups as it is likely that those casualties with
more severe injuries would have required a tourni-
quet, but those with a more severe injury are also
likely to have worse outcomes and experience more
complications.”31
Meta-analysis of the 9 studies reporting survival
for adult military casualties treated with tourniquets
demonstrated a summary effect size estimate for sur-
vival rate of 92% with 95% confidence intervals of
88–95%. Findings in the study of children were simi-
lar (92%, with CI 84–96%). The study of a civilian pop-
ulation was small (11 cases), so the confidence inter-
val was wide, but the survival rate similar (91%, CI
56–99%). A similar analysis for 6 studies reporting am-
putation rates demonstrated a summary effect size es-
timate of 19% with a 95% confidence interval from
16–23%. These amputations are presumably primar-
ily associated with the severity of the extremity injury,
as they are not described as complications of tourni-
quet use. The overall quality of the evidence for PI-
COTS Question 1 was rated using the GRADE system
as Moderate for survival based on upgrading due to
the large effect size and Very Low for amputation rate
(Table 2).
There were no studies available that directly ad-
dressed PICOTS questions 2, 3, and 4. These included
the efficacy of junctional hemorrhage control devices
or the comparison of different brand or models of
tourniquets. Regarding PICOTS question 5, there were
4 studies that correlated duration of tourniquet use
with adverse events but specifics were not provided on
the timing and setting of tourniquet removal.27,30,32,33
Thus, the grade of evidence for PICOTS question 5 was
rated as Low.
Hemostatic Agents
Seven studies were reviewed that reported on the
prehospital use of hemostatic dressings (Table 3). Five
were conducted in a military setting. One was civilian
and 1 included both military and civilian data. The
products tested included HemCon (3 studies), Celox (1
study), QuickClot granules (2 studies), and QuickClot
Gauze (1 study). One study did not report the type
of hemostatic dressings used. Only 1 study reported
mortality and 4 studies reported on adverse events.
No studies provided a direct comparison between
the use of hemostatic dressings and simply applying
direct pressure to the wound. The primary adverse
event noted was pain and discomfort associated with
an exothermic reaction to QuickClot granules.
The primary outcome for 5 studies was cessation
of bleeding. The study by Brown et al.34 reported that
HemCon controlled external hemorrhage in 27 of 34
cases (79%); in 25 cases the bleeding stopped within 3
minutes of application. The study by Cox et al.35 is con-
founded because 7 of the 8 patients treated with hemo-
static dressings in the field were also treated with a
tourniquet. The study by Pozza and Millner36 reported
that Celox stopped bleeding in 18 gunshot wounds
when first applied and in 3 additional cases with
further application. The study by Ran et al.37 reported
that QuickClot gauze successfully stopped bleeding in
11 out of 14 cases of extremity and truncal hemorrhage.
The study by Rhee et al.38 reported that QuickClot
granules were 100% effective in stopping bleeding. In
the study by Wedmore et al.,39 medics were surveyed
on their use of HemCon dressing. In 42 of the 64
cases, the dressings were used when traditional gauze
dressings or pressure dressings failed to stop bleeding.
In 62 of the 64 cases, HemCon successfully stopped
the bleeding. The risk of bias associated with these
studies is high because they are all single-arm studies
with no comparison group. Sufficient data were not
available to provide an estimate of survival rates or
amputation rates in patients treated with hemostatic
dressings. The overall strength of evidence for Key
Question 6 was graded as Low using the GRADE
system.
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TABLE 2. Key Question 1: Strength of evidence grades for survival rate and amputation rate with prehospital tourniquet use
Decrease GRADE Increase GRADE
Outcome
#Studies
(total N)
Typ e o f
studies Findings
Starting
GRADE
Study limitations
Consistency
Directness
Precision
Publication bias
Large magnitude of effect
Dose-response
Confounders
GRADE of
evidence for
outcome
Survival rate 9 studies of
military
personnel
(1,229)
Observational 91.9% (95%
confidence interval
[CI]: 88.1% to
94.6%)
Low −1 Absence of
comparison group
0000 +2 (7-fold
improvement over
historical military
data)
0 0 Moderate
Amputation rate 6 (556) Observational 19.2% (95% CI:
15.8% to 23.2%)
Low −1 Absence of
comparison group
0000 0 00 VeryLow
169
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170 PREHOSPITAL EMERGENCY CARE APRIL/JUNE 2014 VOLUME 18 / NUMBER 2
Table 3. Studies of prehospital hemostatic dressings
Reference Setting Period of data collection Number of casualties treated Patient characteristics
Brown et al., 200934 U.S. civilian June 2006 to Aug 2006 HemCon
n
=34 53% extremity wounds, 68%
male, mean age of
51.5 years, range of
16–91 years.
Cox et al., 200935 U.S. military
Iraq
April 2006 to Oct 2006 HemCon
n
=5, QuikClot
granules
n
=3
7 of 8 extremity wounds,
other data not reported.
Lairet et al., 201220 U.S. military
Afghanistan
Nov 2009 to Nov 2011 Not specified
n
=23,
Compression
n
=371
For all 1,003 patients in the
study, the mechanism of
injury was explosion 60%,
penetrating 24%, blunt
15%. 97% male, mean age
of 25 years.
Pozza and Millner, 201036 U.S. military
Afghanistan
April 2008 to April 2008 Celox =21 All gunshot wounds. All
male between ages of 18
and 45 years.
Ran et al., 201037 Israel military 2009 Quikclot Combat Gauze n =
14
Injuries: blast =7, gunshot =
6, stab =1. Other data not
reported.
Rhee et al., 200838 U.S. civilian and U.S.
military
Iraq
Not specified, but study
was completed in 2006
QuikClot granules n =103
(69 treated by U.S. military
personnel, 20 treated by
civilian trauma surgeons,
14 treated by civilian first
responders)
Injuries for all patients:
explosion 21%, gunshot
66%, blunt 8%, stab wound
5%.
Wedmore et al., 200639 U.S. military
Iraq/Afghanistan
2003 to 2004 HemCon n =64 55% extremity wounds;
bleeding was
predominantly from a
venous source in 33 cases,
arterial source in 7 cases,
and unknown in 24 cases.
In regard to PICOTS Question 7, there were no
patient studies that directly compared the different
hemostatic dressings. The U.S. military has developed
a standardized swine model, which involves a femoral
artery injury with a standard period of free bleeding.
This literature was summarized and reviewed by the
expert panel. For the details of this review please see
the full ECRI Institute report. These data factored into
the recommendation by the panel for the use of a gauze
format product that could be packed into the wound.
The panel also supported the use of this standardized
model for comparison of different products.
RECOMMENDATIONS BY EXPERT PANEL
The recommendations of the panel for management of
external hemorrhage are summarized in Figure 2.
Tourniquets
Recommendation 1:
We recommend the use of tourni-
quets in the prehospital setting for the control of sig-
nificant extremity hemorrhage if direct pressure is in-
effective or impractical.
Strength of Recommendation: Strong
Quality of Evidence: Moderate. The overall quality of
the evidence for survival benefits of tourniquet use
was upgraded from Low to Moderate, based on the
large effect size. The evidence for preventing ampu-
tation was very low, due to a smaller effect size and
issues relating to confounding (see Table 2).
Remarks: The panel believes that tourniquets used to
treat severe extremity hemorrhage have a clear sur-
vival benefit, demonstrated by a large and consistent
effect size across several studies. The panel discussed
that direct pressure may be ineffective in the set-
ting of major arterial injury or impractical in circum-
stances with limited manpower, unsecure scene, or
when complex extrication or extraction is required.
Recommendation 2:
We suggest using commercially
produced windlass, pneumatic, or ratcheting devices
that have been demonstrated to occlude arterial flow.
Strength of Recommendation: Weak
Quality of Evidence: Low
Remarks: The panel discussed the military experi-
ence with varying types of tourniquets and felt that
tourniquet selection should be based on proven ef-
fectiveness at arterial occlusion. Tourniquets that im-
pede venous return without adequate arterial oc-
clusion may only worsen hemorrhage and increase
complications.
Recommendation 3:
We suggest against the use of nar-
row, elastic, or bungee-type devices.
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E. M. Bulger et al. PREHOSPITAL GUIDELINE FOR EXTERNAL HEMORRHAGE CONTROL 171
FIGURE 2. Protocol for prehospital external hemorrhage control.
Strength of Recommendation: Weak
Quality of Evidence: Low
Remarks: The panel discussed the military experi-
ence with varying types of tourniquets and felt that
tourniquet selection should be based on proven ef-
fectiveness at arterial occlusion. Tourniquets that im-
pede venous return without adequate arterial oc-
clusion may only worsen hemorrhage and increase
complications.
Recommendation 4:
We suggest that improvised
tourniquets be applied only if no commercial device
is available.
Strength of Recommendation: Weak
Quality of Evidence: Low
Remarks: The panel discussed the military experi-
ence with varying types of tourniquets and felt that
tourniquet selection should be based on proven ef-
fectiveness at arterial occlusion. Tourniquets that im-
peded venous return without adequate arterial oc-
clusion may only worsen hemorrhage and increase
complications. Commercially available tourniquets
are favored over improvised tourniquets unless
there is no other option.
Recommendation 5:
We suggest against releasing a
tourniquet that has been properly applied in the pre-
hospital setting until the patient has reached definitive
care.
Strength of Recommendation: Weak
Quality of Evidence: Low
Remarks: Given the relatively short transport times for
most civilian EMS agencies, the committee felt the
safest option was to leave a tourniquet that had been
placed in the field in place until the patient can be
assessed in the hospital. There may be exceptions to
this approach for prolonged transport times or aus-
tere environments. In these circumstances, prehospi-
tal providers should consult direct (online) physician
medical direction.
Junctional Hemorrhage Devices
Regarding the questions related to junctional hemor-
rhage devices, we believe this is an important area for
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172 PREHOSPITAL EMERGENCY CARE APRIL/JUNE 2014 VOLUME 18 / NUMBER 2
further study, but did not find sufficient evidence to
make a recommendation at this time.
Topical Hemostatic Agents
Recommendation 1:
We suggest the use of topi-
cal hemostatic agents, in combination with direct
pressure, for the control of significant hemorrhage
in the prehospital setting in anatomic areas where
tourniquets cannot be applied and where sustained di-
rect pressure alone is ineffective or impractical.
Strength of Recommendation: Weak
Quality of Evidence: Low
Remarks: While the evidence was low, there are con-
sistent data from animal models, suggesting reduced
hemorrhage with these agents compared to standard
gauze and the committee felt that junctional hemor-
rhage and torso wounds may benefit from the com-
bination of direct pressure and hemostatic dressings.
Recommendation 2:
We suggest that topical hemostatic
agents be delivered in a gauze format that supports
wound packing.
Strength of Recommendation: Weak
Quality of Evidence: Low
Remarks: This recommendation was based on the mil-
itary experience and the animal studies suggesting
that products that allow packing of the wound have
superior hemorrhage control.
Recommendation 3:
Only products determined effec-
tive and safe in a standardized laboratory injury model
should be used.
Strength of Recommendation: Weak
Quality of Evidence: Low
Remarks: The U.S. Army Institute for Surgical Re-
search has developed a standardized large animal
model for comparison of hemostatic dressings. The
committee felt that all new products should be sub-
ject to this testing.
Additional Training Recommendations
•We advise that tourniquets and topical hemostatic
agents be used under clinical practice guidelines and
following product specific training.
•We advise that hemostatic agent training for prehos-
pital personnel include proper wound packing and
pressure application techniques.
•We advise that tourniquets and topical hemostatic
agents use be expanded to include all prehospi-
tal personnel, including emergency medical respon-
ders (in concordance with the Hartford Consensus
Statement8).
NEED FOR ADDITIONAL RESEARCH
While the military data were convincing that the use
of tourniquets to control severe extremity hemorrhage
is life saving, there remain several unanswered ques-
tions regarding the logistics of hemorrhage control in
the civilian EMS community. The evidence available
to assess many of the practical issues surrounding the
use of tourniquets and hemostatic agents in the civil-
ian community is very limited. There were insuffi-
cient data to make any recommendations regarding the
newly developed devices for junctional hemorrhage
control. There were insufficient data to make any spe-
cific recommendations regarding application in the ex-
tremes of age including pediatric and elderly patients.
Future research should focus on these gaps in knowl-
edge to further guide clinicians in the civilian applica-
tion of these products.
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