Cerebral sinus thrombosis in a trauma patient after recombinant activated factor VII infusion.

Department of Anesthesiology, Mannheim University Clinic, Germany.
Anesthesiology (Impact Factor: 5.16). 03/2004; 100(2):441-3. DOI: 10.1097/00000542-200402000-00037
Source: PubMed
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    ABSTRACT: Organ donation serves a public health function but is also an important part of end-of-life care. Nearly 40% of organ donors are the victims of traumatic brain injury (TBI). We report on a series of patients with nonsurvivable TBI and severe coagulopathy or active hemorrhage who went on to successful organ donation with the use of recombinant factor VIIa (rFVIIa). Organ donors from a 6-year period were identified from the local Organ Procurement Organization (OPO). Medical records were reviewed, and demographics, injury-specific data, coagulation profiles, and medications administered were abstracted. Outcomes data on early graft function after transplantation were obtained. One hundred forty-eight patients had organ recovery after either brain death or withdrawal of care. Twenty-nine patients received rFVIIa and 119 patients did not. rFVIIa was administered before determination of nonsurvivability or brain death in 21 patients. In eight patients, rFVIIa was administered as a specific salvage therapy to allow donation. Mean Injury Severity Score in the rFVIIa group was 43.4 (+/-14.8) versus 34.0 (+/-13.3) in the group that did not receive rFVIIa (p = 0.001). Organs transplanted per donor were no different in the 2 groups (3.5 versus 3.6; p = 0.7). There were nearly twice as many successfully recovered lungs from the donors who received rFVIIa (44.1% versus 26.2%; p = 0.04). There was no difference in early graft function in the two groups when recipient outcomes were compared. Use of rFVIIa facilitated donation in patients with multisystem injuries who otherwise might have been ineligible for organ donation. Use of rFVIIa did not affect early graft function, although longterm outcomes are unknown. Recombinant factor VIIa is expensive, but its use is justified if the donor organ supply can be increased.
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    ABSTRACT: Notwithstanding its limited Food and Drug Administration-approved indications, rFVIIa has rapidly gained widespread use for the treatment of a variety of hemorrhagic conditions, including intracranial bleeding from spontaneous, traumatic, surgical, and coagulopathic causes. Although it appears that the drug only minimally increases the risk of thromboembolic events, its efficacy remains in question. The idea of finding a universal cure for hemorrhage in a medication bottle remains highly appealing, but enthusiasm for the concept is no replacement for evidence. Neuroscience nurses, who are the interface between patients and rFVIIa, need to balance hope and hype until the facts are all in.
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    ABSTRACT: Factor VIIa (recombinant) has an off-label use to control life-threatening bleeding that is refractory to other measures and was shown to decrease transfusion requirements. The primary objective of this study was to assess the safety and effectiveness of factor VIIa (recombinant) on blood transfusion requirements and coagulation parameters when used in patients whose bleeding was uncorrected by other means. The pharmacoeconomic impact for any discrepancy from our protocol was evaluated. Secondary outcomes included 4-hour and 28-day mortality, as well as safety of this agent in terms of thromboembolic complications. We retrospectively evaluated patients who received recombinant-activated factor VII (rFVIIa) for uncontrolled bleeding from June 2008 to April 2011. The medical records of 33 patients were evaluated. Coagulation parameters and blood products were determined 24 hours before and 24 hours after administration of rFVIIa, and the results compared. Patients were also screened for any thromboembolic complications. Administration of rFVIIa reduced blood transfusion requirements and improved coagulation parameters significantly (P<0.05). No thromboembolic complications were reported. Most of the dosing was consistent with those recommended in our institutional protocol, with discrepancies resulting in an average cost of $56 058. Moreover, pH was reported in only 67% of patients. All patients treated with rFVIIa survived up to 4 hours after receiving this agent, while the 28-day mortality was 24% (8/33). The use of rFVIIa appears to be safe and effective in promoting hemostasis, as evident from reducing transfusion requirements and improving the coagulation variables.
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