EXCLAIM:Extended Prophylaxis for Venous ThromboEmbolism (VTE) in Acutely Ill Medical Patients With Prolonged Immobilization
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|ClinicalTrials.gov Identifier: NCT00077753|
Recruitment Status : Completed
First Posted : February 16, 2004
Last Update Posted : January 11, 2011
- To demonstrate the superiority of extended VTE prophylaxis with enoxaparin 40mg sc qd for 28 ± 4 days, compared to placebo, both following 10 ± 4 days of initial treatment with enoxaparin 40mg sc qd
- To assess the reduction in mortality rate at the end of the double-blind treatment period, at 3 (90 ± 10 days) and at 6 (180 ± 10 days) months from the time of entry to the study, in patients on extended prophylaxis
- To assess the incidence of VTE at 3 months (90 ± 10 days) from the time of randomization to the study
To evaluate the safety of extended enoxaparin VTE prophylaxis in acutely ill medical patients with prolonged immobilization. Safety evaluation includes:
- Major and minor hemorrhage
- Heparin induced thrombocytopenia
- Serious adverse events
- To assess differences in levels of health-care utilization and cost between patients receiving extended VTE prophylaxis versus those receiving placebo.
|Condition or disease||Intervention/treatment||Phase|
|Venous Thromboembolism||Drug: enoxaparin sodium||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||4726 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Double-Blind, Placebo-Controlled, Parallel, Multicenter Study on Extended VTE Prophylaxis in Acutely Ill Medical Patients With Prolonged Immobilization|
|Study Start Date :||February 2002|
|Actual Primary Completion Date :||October 2006|
|Actual Study Completion Date :||February 2007|
- During double blind treatment : Cumulative occurrence of VTE assessed by ultrasound for all patients at 28±4 days after randomization (or earlier if symptomatic VTE) and/or V/Q lung scan for symptomatic patients ; Major hemorrhagic complications.
- Occurrence of VTE between Day 1 and Day 90±10, Mortality at the end of Double-Blind Treatment, at 3 and 6 months
- Minor plus major hemorrhagic complications during Double-Blind Treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00077753
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|Study Director:||Luc Sagnard||Sanofi|