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
Acknowledgment: The authors thank Min Chen and Genevieve Salette (sanofi-aventis) for their statistical analysis, Rachel Spice (Excerpta Medica) for providing editorial support, and Bruno Deslandes (sanofi-aventis) for critically reviewing the content.
Grant Support: By sanofi-aventis, which also funded editorial support.
Potential Conflicts of Interest: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M09-0393.
Reproducible Research Statement:Study protocol: See reference 11. Statistical code: Not available. Data set: Available on request from the EXCLAIM Steering Committee (e-mail, email@example.com).
Requests for Single Reprints: Russell D. Hull, MBBS, Thrombosis Research Unit, University of Calgary, Foothills Hospital, Room 601 South Tower, 1403 29th Street Northwest, Calgary, Alberta T2N 2T9, Canada; e-mail, firstname.lastname@example.org.
Current Author Addresses: Dr. Hull: Thrombosis Research Unit, University of Calgary, Foothills Hospital, Room 601 South Tower, 1403 29th Street Northwest, Calgary, Alberta T2N 2T9, Canada.
Dr. Schellong: Division of Angiology, University Hospital Carl Gustav Carus, Fetscherstraße 74, 01307 Dresden, Germany.
Dr. Tapson: Duke University Medical Center, Hanes House, Room 128, Durham, NC 27710.
Dr. Monreal: Carretera de Canyet s/n, Barcelona, 08916, Spain.
Dr. Samama: Départment d'Hématologie Biologique, Hôtel Dieu, 75181 Paris, France.
Dr. Nicol: sanofi-aventis, 174 Avenue de France, 75635 Paris Cedex 13, France.
Dr. Vicaut: Clinical Research Unit, Hôpital F. Widal, 200 Rue du Faubourg St-Denis, 75010 Paris, France.
Dr. Turpie: Hamilton General Hospital, 237 Barton Street East, Hamilton, Ontario L8I 2X2, Canada.
Dr. Yusen: Washington University School of Medicine, 660 South Euclid Avenue, Box 8052, St. Louis, MO 63110.
Author Contributions: Conception and design: R.D. Hull, S.M. Schellong, V.F. Tapson, M. Monreal, A.G.G. Turpie, R.D. Yusen.
Analysis and interpretation of the data: R.D. Hull, S.M. Schellong, V.F. Tapson, M.M. Samama, E. Vicaut, A.G.G. Turpie, R.D. Yusen.
Drafting of the article: R.D. Hull, M. Monreal, R.D. Yusen.
Critical revision of the article for important intellectual content: R.D. Hull, S.M. Schellong, V.F. Tapson, M. Monreal, M.M. Samama, A.G.G. Turpie, R.D. Yusen.
Final approval of the article: R.D. Hull, S.M. Schellong, V.F. Tapson, M. Monreal, M.M. Samama, A.G.G. Turpie, R.D. Yusen.
Provision of study materials or patients: R.D. Hull, S.M. Schellong, V.F. Tapson, M. Monreal, A.G.G. Turpie, R.D. Yusen.
Statistical expertise: R.D. Hull, S.M. Schellong, E. Vicaut, R.D. Yusen.
Administrative, technical, or logistic support: S.M. Schellong, P. Nicol.
Collection and assembly of data: R.D. Hull, V.F. Tapson, M. Monreal, M.M. Samama, A.G.G. Turpie, P. Nicol, R.D. Yusen.
For a list of the EXCLAIM study investigators, see Appendix 1.
Hull RD, Schellong SM, Tapson VF, Monreal M, Samama M, Nicol P, et al. 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.
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.
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Venous Thromboembolism, Prevention/Screening.
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