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Do the Benefits of Prolonged Low-Molecular-Weight Heparin Treatment Outweigh the Harms in Hospitalized Patients Who Are Bedbound? FREE

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The summary below is from the full report titled “Extended-Duration Venous Thromboembolism Prophylaxis in Acutely Ill Medical Patients With Recently Reduced Mobility. A Randomized Trial.” It is in the 6 July 2010 issue of Annals of Internal Medicine (volume 153, pages 8-18). The authors are R.D. Hull, S.M. Schellong, V.F. Tapson, M. Monreal, M.M. Samama, P. Nicol, E. Vicaut, A.G. Turpie, and R.D. Yusen, for the EXCLAIM (Extended Prophylaxis for Venous ThromboEmbolism in Acutely Ill Medical Patients With Prolonged Immobilization) study.

Ann Intern Med. 2010;153(1):I-50. doi:10.7326/0003-4819-153-1-201007060-00002
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What is the problem and what is known about it so far?

Patients who have had major surgery or who are seriously ill are often bedbound during their illness. When patients are bedbound, blood flow in the legs slows, and they are more likely to develop blood clots. Doctors often give a blood thinner known as “low-molecular-weight heparin” to prevent clots. However, this drug also causes bleeding. Researchers have shown that receiving low-molecular-weight heparin for 1 month after surgery reduces more blood clots and is about as safe as receiving it for a week. It is unclear whether receiving the therapy for longer periods is similarly effective and safe in persons who are bedbound because they are seriously ill, not because they required surgery.

Why did the researchers do this particular study?

To see whether giving low-molecular-weight heparin for an additional month to persons who are bedbound because they are seriously ill prevents more blood clots and is as safe as giving it for 1 to 2 weeks.

Who was studied?

5963 participants who were bedbound and hospitalized because of serious illness at 370 hospitals.

How was the study done?

The researchers gave all the study participants low-molecular-weight heparin for 1 to 2 weeks. Then, half of the patients, chosen at random, received an additional 3 to 4 weeks of low-molecular-weight heparin; the other half received placebo. The researchers followed each group for 6 months to see how many participants developed blood clots or had serious bleeding events.

What did the researchers find?

Participants who received low-molecular-weight heparin for the additional month had fewer blood clots. These patients bled more, but the additional treatment prevented more blood clots than it caused bleeding. When the researchers looked closely at their findings, they discovered that the benefits of the additional treatment were greater than its harms only for women, persons older than 75 years, and those who were so sick that they were not allowed to leave their bed, even to use the bathroom.

What were the limitations of the study?

When the researchers initially conducted the study, they found that the additional month of treatment was not effective at preventing clots and caused more bleeding than placebo. They then recruited persons who were at even higher risk for blood clots to see whether additional treatment might be more helpful. As a result, these findings apply only to persons who have the highest risk for blood clots.

What are the implications of the study?

Compared with treatment for 1 to 2 weeks, low-molecular-weight heparin therapy for an additional month is probably more beneficial than harmful for women, patients older than 75 years, and those who are hospitalized and so sick that they cannot or are not allowed to leave their bed.





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