The Use of Low Molecular Weight Heparin in Traumatic Brain Injury
This study has suspended participant recruitment.
Sponsor:
Minneapolis Medical Research Foundation
Collaborator:
Aventis Pharmaceuticals
Information provided by:
Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier:
NCT00170378
First received: September 12, 2005
Last updated: October 3, 2012
Last verified: October 2012
| Tracking Information | |||||
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| First Received Date ICMJE | September 12, 2005 | ||||
| Last Updated Date | October 3, 2012 | ||||
| Start Date ICMJE | December 2002 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Safety: Assess if early administration of LMWH exacerbates intracranial hemorrhage. | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00170378 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Efficacy: Demonstrate effectiveness of dosing regimen in preventing VTE. | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Use of Low Molecular Weight Heparin in Traumatic Brain Injury | ||||
| Official Title ICMJE | The Use of Low Molecular Weight Heparin in Traumatic Brain Injury | ||||
| Brief Summary | To study the safety and efficacy of early administration of Low Molecular Weight Heparin to patients with traumatic brain injury. |
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| Detailed Description | Venous thromboembolic (VTE) prophylaxis in trauma patients is a critical clinical problem. Patients with traumatic brain injury usually have effective VTE prophylaxis withheld secondary to concerns of exacerbating intracranial hemorrhage. This study examines the safety and efficacy of early administration (within 24 hrs of admission) of low molecular weight heparin to this patient population with very high VTE risk. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: Enoxaparin | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Suspended | ||||
| Enrollment ICMJE | 300 | ||||
| Completion Date | August 2005 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00170378 | ||||
| Other Study ID Numbers ICMJE | HSR #02-2113 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Minneapolis Medical Research Foundation | ||||
| Collaborators ICMJE | Aventis Pharmaceuticals | ||||
| Investigators ICMJE |
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| Information Provided By | Minneapolis Medical Research Foundation | ||||
| Verification Date | October 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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