Russell D. Hull, MBBS; Sebastian M. Schellong, MD; Victor F. Tapson, MD; Manuel Monreal, MD; Meyer-Michel Samama, MD, PharmD; Philippe Nicol, PhD; Eric Vicaut, MD, PhD; Alexander G.G. Turpie, MD; Roger D. Yusen, MD, MPH; EXCLAIM (Extended Prophylaxis for Venous ThromboEmbolism in Acutely Ill Medical Patients With Prolonged Immobilization) study
Extended-duration low-molecular-weight heparin has been shown to prevent venous thromboembolism (VTE) in high-risk surgical patients.
To evaluate the efficacy and safety of extended-duration enoxaparin thromboprophylaxis in acutely ill medical patients.
Randomized, parallel, placebo-controlled trial. Randomization was computer-generated. Allocation was centralized. Patients, caregivers, and outcome assessors were blinded to group assignment. (ClinicalTrials.gov registration number: NCT00077753)
370 sites in 20 countries across North and South America, Europe, and Asia.
Acutely ill medical patients 40 years or older with recently reduced mobility (bed rest or sedentary without [level 1] or with [level 2] bathroom privileges). Eligibility criteria for patients with level 2 immobility were amended to include only those who had additional VTE risk factors (age >75 years, history of VTE, or active or previous cancer) after interim analyses suggested lower-than-expected VTE rates.
Enoxaparin, 40 mg/d subcutaneously (2975 patients), or placebo (2988 patients), for 28Â Â±Â 4 days after receiving open-label enoxaparin for an initial 10Â Â±Â 4 days.
Incidence of VTE up to day 28 and of major bleeding events up to 48 hours after the last study treatment dose.
Extended-duration enoxaparin reduced VTE incidence compared with placebo (2.5% vs. 4%; absolute risk difference favoring enoxaparin, âˆ’1.53% [95.8% CI, âˆ’2.54% to âˆ’0.52%]). Enoxaparin increased major bleeding events (0.8% vs. 0.3%; absolute risk difference favoring placebo, 0.51% [95% CI, 0.12% to 0.89%]). The benefits of extended-duration enoxaparin seemed to be restricted to women, patients older than 75 years, and those with level 1 immobility.
Estimates of efficacy and safety for the overall trial population are difficult to interpret because of the change in eligibility criteria during the trial.
Use of extended-duration enoxaparin reduces VTE more than it increases major bleeding events in acutely ill medical patients with level 1 immobility, those older than 75 years, and women.
Hull RD, Schellong SM, Tapson VF, et al, EXCLAIM (Extended Prophylaxis for Venous ThromboEmbolism in Acutely Ill Medical Patients With Prolonged Immobilization) study. Extended-Duration Venous Thromboembolism Prophylaxis in Acutely Ill Medical Patients With Recently Reduced Mobility: A Randomized Trial. Ann Intern Med. 2010;153:8–18. doi: 10.7326/0003-4819-153-1-201007060-00004
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Published: Ann Intern Med. 2010;153(1):8-18.
Prevention/Screening, Venous Thromboembolism.
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