NCT00622648: Study to Evaluate the Mortality Reduction of Enoxaparin in Hospitalized…

Summary

The primary objective: * To demonstrate in patients hospitalized for an acute medical illness that enoxaparin with Graduated Elastic Stockings is superior to enoxaparin-placebo with Graduated Elastic Stockings on overall mortality at day 30 after randomization. The secondary objective: * To compare, in patients hospitalized for an acute medical illness, enoxaparin with Graduated Elastic Stockings versus enoxaparin placebo with Graduated Elastic Stockings on overall mortality at day 90 after randomization. * To evaluate the safety of enoxaparin VTE prophylaxis in patients hospitalized for acute medical illness with respect to major hemorrhage, total bleedings, heparin induced thrombocytopenia, adverse events and serious adverse events .

Timeline

Start: 2008-01
Primary completion: 2010-12
Completion: 2010-12

Outcome

Missed primary endpoint

paper was not associated with a reduction in the rate of death from any cause among hospitalized, acutely ill medical patients. PMID 22204723 ↗

paper risk ratio, 1.0; 95% confidence interval [CI], 0.8 to 1.2; P=0.83 PMID 22204723 ↗

Publications

Kakkar AK, Cimminiello C, Goldhaber SZ, Parakh R, Wang C, Bergmann JF; LIFENOX Investigators. Low-molecular-weight heparin and mortality in acutely ill medical patients. N Engl J Med. 2011 Dec 29;365(26):2463-72. doi: 10.1056/NEJMoa1111288.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Enoxaparin sodium	Other / unclassified	40 mg	Subcutaneous

Indications