Prevention of Venous Thromboembolism in Patients With Acute Primary Intracerebral Hemorrhage
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|ClinicalTrials.gov Identifier: NCT00699465|
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
- 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|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
Active Comparator: 1
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.
Placebo Comparator: 2
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.
- 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 ]
- 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 ]
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
|Contact: Matti E Hillbom, MD, PhDemail@example.com|
|Contact: Juha T Huhtakangas, MDfirstname.lastname@example.org|
|Department of Neurology, Oulu University Hospital||Recruiting|
|Oulu, Finland, 90029 OYS|
|Contact: Matti E Hillbom, professor 358-8-315-4518 email@example.com|
|Contact: Juha T Huhtakangas, MD 358-8-315-4032 firstname.lastname@example.org|
|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:||Aimo Rissanen, MD, PhD||Keski-Suomen Keskussairaala|
|Principal Investigator:||Heikki Numminen, MD, PhD||Tampere University Hospital|