Prevention of Venous Thromboembolism in Patients With Acute Primary Intracerebral Hemorrhage
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| ClinicalTrials.gov Identifier: NCT00699465 |
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Recruitment Status : Unknown
Verified July 2010 by University of Oulu.
Recruitment status was: Recruiting
First Posted : June 18, 2008
Last Update Posted : July 2, 2010
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Sponsor:
University of Oulu
Collaborator:
University of Helsinki
Information provided by:
University of Oulu
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Intracerebral Hemorrhage | Drug: enoxaparin Drug: enoxaparin placebo | Phase 4 |
- 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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 320 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Prevention |
| Official Title: | 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) |
| Study Start Date : | August 2008 |
| Estimated Primary Completion Date : | July 2013 |
| Estimated Study Completion Date : | December 2013 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
COL4A1-related brain small-vessel disease
MedlinePlus related topics:
Bleeding
Drug Information available for:
Enoxaparin sodium
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: 1
Early enoxaparin
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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:
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Placebo Comparator: 2
Late enoxaparin
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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:
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Primary Outcome Measures :
- 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. [ Time Frame: 90 days ]
Secondary Outcome Measures :
- Bleeding complications including rebleedings occurring within the treatment period [ Time Frame: 90 days ]
- Increase in ICH volume observed by head CT or at autopsy during the treatment period [ Time Frame: 90 days ]
- Cardiovascular death occurring within the treatment period [ Time Frame: 90 days ]
- Death due to any cause occurring within the treatment period [ Time Frame: 90 days ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
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): NCT00699465
Contacts
| Contact: Matti E Hillbom, MD, PhD | 358-8-315-4518 | matti.hillbom@oulu.fi | |
| Contact: Juha T Huhtakangas, MD | 358-8-315-4032 | juha.huhtakangas@ppshp.fi |
Locations
| Finland | |
| Department of Neurology, Oulu University Hospital | Recruiting |
| Oulu, Finland, 90029 OYS | |
| Contact: Matti E Hillbom, professor 358-8-315-4518 matti.hillbom@oulu.fi | |
| Contact: Juha T Huhtakangas, MD 358-8-315-4032 juha.huhtakangas@ppshp.fi | |
| Sub-Investigator: Tarja H Haapaniemi, MD, PhD | |
| Sub-Investigator: Sami T Tetri, MD | |
| Sub-Investigator: Michaela Bode, MD, PhD | |
| Sub-Investigator: Pertti Saloheimo, MD, PhD | |
| Sub-Investigator: Eeva-Riitta Savolainen, MD, PhD | |
Sponsors and Collaborators
University of Oulu
University of Helsinki
Investigators
| Study Chair: | Matti E Hillbom, MD, PhD | Oulu University Central Hospital, Department of Neurology | |
| Study Director: | Seppo S Juvela, MD, PhD | Turku University Central Hospital, Department of Neurosurgery | |
| Principal Investigator: | Turgut Tatlisumak, MD, PhD | Helsinki University Central Hospital, Department of Neurology | |
| Principal Investigator: | Liisa K Luostarinen, MD, PhD | Päijät-Häme Central Hospital, Department of Neurology | |
| Principal Investigator: | Aimo Rissanen, MD, PhD | Keski-Suomen Keskussairaala | |
| Principal Investigator: | Heikki Numminen, MD, PhD | Tampere University Hospital |
Publications:
| Responsible Party: | Oulu University Hospital (Matti Hillbom), Oulu University Hospital |
| ClinicalTrials.gov Identifier: | NCT00699465 |
| Other Study ID Numbers: |
EUDRACT 2007-006206-24 |
| First Posted: | June 18, 2008 Key Record Dates |
| Last Update Posted: | July 2, 2010 |
| Last Verified: | July 2010 |
Keywords provided by University of Oulu:
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Thromboprophylaxis Prevention of venous thromboembolism after ICH Enoxaparin Intermittent pneumatic compression |
Additional relevant MeSH terms:
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Cerebral Hemorrhage Thromboembolism Venous Thromboembolism Hemorrhage Pathologic Processes Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Intracranial Hemorrhages |
Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Enoxaparin Anticoagulants Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action |