NCT00699465

Prevention of Venous Thromboembolism in Patients With Acute Primary Intracerebral Hemorrhage

A Double-blind Randomized Trial to Compare the Efficacy of Intermittent Pneumatic Compression (IPC) With and Without Early Anticoagulant Treatment for Prevention of Venous Thromboembolism (VTE) in Patients With Acute Primary Intracerebral Hemorrhage (ICH)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 320 (estimated)
• Sponsor: University of Oulu · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

* To evaluate the efficacy of using IPC during the acute phase of ICH in the prevention of VTE. * To assess the safety and efficacy of additional therapy with enoxaparin. * To compare the efficacy and safety of the European and American guideline recommendations. * To provide an efficient and safe thromboprophylaxis for several weeks until the patient is able to walk.

Detailed description

* Although it has been poorly investigated, the risk of VTE among patients with acute primary intracerebral hemorrhage is generally believed to be at least as high as among patients with ischemic stroke. * The currently available guidelines state that while low doses of subcutaneous heparin or low-molecular-weight heparin may reduce VTE, it is possible that their effect is counterbalanced by an increase in hemorrhagic complications. * It is still unclear when (if ever) low-molecular-weight-heparin should be safely initiated in ICH patients.

Conditions

• Intracerebral Hemorrhage

Interventions

Type	Name	Description
DRUG	enoxaparin	20 mg enoxaparin (2 000 IU) s.c. will be given twice daily starting 24-48 h after onset of the stroke. Intermittent pneumatic compression will be started immediately after admission.
DRUG	enoxaparin placebo	Placebo will be given s.c. twice daily starting 24-48 h after onset of the stroke for 2 days. Thereafter, 20 mg enoxaparin (2 000 IU) s.c. will be given twice daily. Intermittent pneumatic compression will be started immediately after admission.

Timeline

• Start date: 2008-08-01
• Primary completion: 2013-07-01
• Completion: 2013-12-01
• First posted: 2008-06-18
• Last updated: 2010-07-02

Locations

1 site across 1 country: Finland