Trial | NCT00699465  Report issue

Title

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)

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    enoxaparin ...

  • Study Participants

    320
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.
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.
Study Started
Aug 31
2008
Primary Completion
Jul 31
2013
Anticipated
Study Completion
Dec 31
2013
Anticipated
Last Update
Jul 02
2010
Estimate

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.

  • Other names: Klexane, Kendall

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.

  • Other names: Klexane, Kendall

1 Active Comparator

Early enoxaparin

2 Placebo Comparator

Late enoxaparin

Criteria 

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
No Results Posted