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Sponsors and Collaborators: |
University of Oulu Helsinki University |
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Information provided by: | University of Oulu |
ClinicalTrials.gov Identifier: | NCT00699465 |
Condition | Intervention | Phase |
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Intracerebral Hemorrhage |
Drug: enoxaparin Drug: enoxaparin placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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) |
Estimated Enrollment: | 320 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
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. |
2: Placebo Comparator
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.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 |
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: | Keijo Koivisto, MD, PhD | Etelä-Pohjanmaan Keskussairaala |
Principal Investigator: | Aimo Rissanen, MD, PhD | Keski-Suomen Keskussairaala |
Principal Investigator: | Heikki Numminen, MD, PhD | Tampere University Central Hospital |
Responsible Party: | Oulu University Hospital ( Oulu University Hospital (Matti Hillbom) ) |
Study ID Numbers: | EUDRACT 2007-006206-24 |
Study First Received: | June 12, 2008 |
Last Updated: | February 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00699465 History of Changes |
Health Authority: | Finland: National Agency for Medicines |
Thromboprophylaxis Prevention of venous thromboembolism after ICH Enoxaparin Intermittent pneumatic compression |
Cerebral Hemorrhage Anticoagulants Vascular Diseases Central Nervous System Diseases Fibrinolytic Agents Cardiovascular Agents Intracranial Hemorrhages Venous Thromboembolism Hemorrhage |
Brain Diseases Cerebrovascular Disorders Thromboembolism Thrombosis Enoxaparin Fibrin Modulating Agents Embolism and Thrombosis Embolism |
Cerebral Hemorrhage Anticoagulants Molecular Mechanisms of Pharmacological Action Hematologic Agents Nervous System Diseases Vascular Diseases Central Nervous System Diseases Fibrinolytic Agents Cardiovascular Agents Intracranial Hemorrhages Hemorrhage Venous Thromboembolism |
Brain Diseases Cerebrovascular Disorders Pharmacologic Actions Thrombosis Thromboembolism Enoxaparin Fibrin Modulating Agents Embolism and Thrombosis Pathologic Processes Therapeutic Uses Cardiovascular Diseases |