Prevention of Venous Thromboembolism in Patients With Acute Primary Intracerebral Hemorrhage

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Intracerebral Hemorrhage

Intervention / Treatment
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* Drug: enoxaparin
* Drug: enoxaparin placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: acute primary ICH > 17 years unable to walk admitted within 12 h after onset of ICH informed consent obtained Exclusion Criteria: other type of ICH than acute primary intracerebral hemorrhage patients who need neurosurgery evidence of VTE at screening thrombolytic treatment within the preceding week major surgery or major trauma within the preceding 3 months life expectancy less than 3 months due to comorbid disorders confirmed malignant disease (cancer) hepatitis and/or liver cirrhosis renal failure infectious disease (HIV, endocarditis etc.) current of previous hematologic disease recent active and untreated gastric/duodenal ulcer allergy or known hypersensitivity to enoxaparin or heparins known hypersensitivity to benzyl alcohol women of childbearing age if pregnant participation in another study within the preceding 30 days

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Early enoxaparin | Drug: enoxaparin<br>* 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.<br>* Other names: Kendall;|
| Placebo Comparator: 2<br>Late enoxaparin | Drug: enoxaparin placebo<br>* 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.<br>* Other names: Kendall;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The cumulative occurrence of confirmed VTE, defined as the composite of symptomatic or asymptomatic DVT, or symptomatic or fatal PE occurring during the treatment period. |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding complications including rebleedings occurring within the treatment period |  | 90 days | 
| Increase in ICH volume observed by head CT or at autopsy during the treatment period |  | 90 days | 
| Cardiovascular death occurring within the treatment period |  | 90 days | 
| Death due to any cause occurring within the treatment period |  | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thromboprophylaxis, Prevention of venous thromboembolism after ICH, Enoxaparin, Intermittent pneumatic compression