Prevention of Venous Thromboembolism in Patients With Acute Primary Intracerebral Hemorrhage
NCT ID: NCT00699465
Last Updated: 2010-07-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
320 participants
INTERVENTIONAL
2008-08-31
2013-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
PREvention of VENous Thromboembolism In Hemorrhagic Stroke Patients
NCT01573169
Early Prophylactic Decompressive Hemicraniectomy Following Endovascular Therapy in Large Hemispheric Infarct Trial
NCT07118345
Endovascular Treatment With or Without Preceding Intravenous Tenecteplase (TNK) in Patients With Late-window acUte Ischemic Stroke Due to Middle Cerebral Artery Occlusion
NCT06221371
Intraventricular Fibrinolysis for Aneurysmal Subarachnoid Hemorrhage.
NCT03187405
Head COOLing in IscHemic Stroke Patients Undergoing EndovAscular Thrombectomy: a Feasibility and Safety StuDy
NCT06335641
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Early enoxaparin
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
Late enoxaparin
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* \> 17 years
* unable to walk
* admitted within 12 h after onset of ICH
* informed consent obtained
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Helsinki
OTHER
University of Oulu
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Oulu University Hospital
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Matti E Hillbom, MD, PhD
Role: STUDY_CHAIR
Oulu University Central Hospital, Department of Neurology
Seppo S Juvela, MD, PhD
Role: STUDY_DIRECTOR
Turku University Central Hospital, Department of Neurosurgery
Turgut Tatlisumak, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Helsinki University Central Hospital, Department of Neurology
Liisa K Luostarinen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Päijät-Häme Central Hospital, Department of Neurology
Aimo Rissanen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Keski-Suomen Keskussairaala
Heikki Numminen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Tampere University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Neurology, Oulu University Hospital
Oulu, , Finland
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Steiner T, Kaste M, Forsting M, Mendelow D, Kwiecinski H, Szikora I, Juvela S, Marchel A, Chapot R, Cognard C, Unterberg A, Hacke W. Recommendations for the management of intracranial haemorrhage - part I: spontaneous intracerebral haemorrhage. The European Stroke Initiative Writing Committee and the Writing Committee for the EUSI Executive Committee. Cerebrovasc Dis. 2006;22(4):294-316. doi: 10.1159/000094831. Epub 2006 Jul 28.
Broderick J, Connolly S, Feldmann E, Hanley D, Kase C, Krieger D, Mayberg M, Morgenstern L, Ogilvy CS, Vespa P, Zuccarello M; American Heart Association; American Stroke Association Stroke Council; High Blood Pressure Research Council; Quality of Care and Outcomes in Research Interdisciplinary Working Group. Guidelines for the management of spontaneous intracerebral hemorrhage in adults: 2007 update: a guideline from the American Heart Association/American Stroke Association Stroke Council, High Blood Pressure Research Council, and the Quality of Care and Outcomes in Research Interdisciplinary Working Group. Stroke. 2007 Jun;38(6):2001-23. doi: 10.1161/STROKEAHA.107.183689. Epub 2007 May 3.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EUDRACT 2007-006206-24
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.