A double-blind and randomized placebo-controlled trial of low molecular weight heparin once daily to prevent deep-vein thrombosis in acute ischemic stroke.

Department of Medicine, Aker University Hospital, Oslo, Norway.
Seminars in Thrombosis and Hemostasis (Impact Factor: 3.69). 11/1990; 16 Suppl:25-33.
Source: PubMed

ABSTRACT The effect of LMW heparin (Kabi 2165, Fragmin) was compared with placebo for the prevention of DVT in 103 patients with acute ischemic stroke using a prospective, double-blind, randomized trial design. Treatment was started within 72 hours, and LMW heparin was administered subcutaneously once daily according to body weight classes, which corresponded to about 55 to 65 Factor-Xa inhibitory U/kg, for 14 days, or until discharge from the hospital, if earlier. All patients underwent thrombosis surveillance with unilateral venography of the paretic limb. Evaluation of venography could be performed in 42 of 52 patients randomized to LMW heparin and in 50 of 51 patients randomized to placebo. The frequency of DVT was 15 of 42 patients or 36% (95% confidence interval 22 to 52%) in the LMW heparin group and 17 of 50 patients or 34% (21 to 49%) in the placebo group. The frequency of proximal thrombi was 5 of 42 (12%) and 8 of 50 (16%), respectively. There was one fatal pulmonary embolism in the placebo group. The mortality rate (28 days follow-up) was 5 of 52 in the LMW heparin group and 1 of 51 in the placebo group (p = 0.24). None of the deaths was related to treatment. No major hemorrhagic complications were observed. The mean Factor Xa inhibitory activity levels at peak concentration were 0.34 U/ml on day 2 and 0.42 U/ml on day 12 (p = 0.02). We conclude that LMW heparin in the dose range studied did not provide efficient prophylaxis against DVT in patients with acute ischemic stroke.

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    ABSTRACT: Critically ill patients may present several risk factors for deep venous thrombosis (DVT). Prevention of DVT can be made with unfractionned heparin and more recently with low molecular weight heparin. Only one trial has been performed to evaluate the prevention of DVT in ICU patients. These patients are hospitalized after major trauma or surgery, or for medical problems and the conclusions of trials which have been performed in these fields can help to treat ICU patients. Surgical patients must be treated by perioperative administration of low dose of subcutaneous heparin. Trauma patients should also receive a prophylaxix, but some patients are at risk of bleeding because of their injury, and non invasive investigations like ultrasonography should be performed for early detection of DVT. In medical patients only several studies have been performed and are in favor of DVT prophylaxis. More studies are needed in homogenous series of ICU patients.
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    ABSTRACT: Thrombo-prophylaxis has been shown to reduce the incidence of pulmonary embolism (PE) and mortality in surgical patients. The purpose of this review is to find out the evidence-based clinical practice criteria of deep vein thrombosis (DVT) prophylaxis in acutely ill medical and critically ill patients. English-language randomized controlled trials, systematic reviews, and meta-analysis were included if they provided clinical outcomes and evaluated therapy with low-dose heparin or related agents compared with placebo, no treatment, or other active prophylaxis in the critically ill and medically ill population. For the same, we searched MEDLINE, PUBMED, Cochrane Library, and Google Scholar. In acutely ill medical patients on the basis of meta-analysis by Lederle et al. (40 trials) and LIFENOX study, heparin prophylaxis had no significant effect on mortality. The prophylaxis may have reduced PE in acutely ill medical patients, but led to more bleeding events, thus resulting in no net benefit. In critically ill patients, results of meta-analysis by Alhazzani et al. and PROTECT Trial indicate that any heparin prophylaxis compared with placebo reduces the rate of DVT and PE, but not symptomatic DVT. Major bleeding risk and mortality rates were similar. On the basis of MAGELLAN trial and EINSTEIN program, rivaroxaban offers a single-drug approach to the short-term and continued treatment of venous thrombosis. Aspirin has been used as antiplatelet agent, but when the data from two trials the ASPIRE and WARFASA study were pooled, there was a 32% reduction in the rate of recurrence of venous thrombo-embolism and a 34% reduction in the rate of major vascular events.
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