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| Name | Class |
|---|---|
| Aventis Pharmaceuticals | INDUSTRY |
To study the safety and efficacy of early administration of Low Molecular Weight Heparin to patients with traumatic brain injury.
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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enoxaparin | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Assess if early administration of LMWH exacerbates intracranial hemorrhage. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Demonstrate effectiveness of dosing regimen in preventing VTE. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John K. Cumming, M.D. | Hennepin County Medical Center/MinneapolisMRF | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12131387 | Background | Kim J, Gearhart MM, Zurick A, Zuccarello M, James L, Luchette FA. Preliminary report on the safety of heparin for deep venous thrombosis prophylaxis after severe head injury. J Trauma. 2002 Jul;53(1):38-42; discussion 43. doi: 10.1097/00005373-200207000-00008. | |
| 12049541 | Background | Norwood SH, McAuley CE, Berne JD, Vallina VL, Kerns DB, Grahm TW, Short K, McLarty JW. Prospective evaluation of the safety of enoxaparin prophylaxis for venous thromboembolism in patients with intracranial hemorrhagic injuries. Arch Surg. 2002 Jun;137(6):696-701; discussion 701-2. doi: 10.1001/archsurg.137.6.696. |
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| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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| ID | Term |
|---|---|
| D017984 | Enoxaparin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
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| 11220715 | Background | Norwood SH, McAuley CE, Berne JD, Vallina VL, Kerns DB, Grahm TW, McLarty JW. A potentially expanded role for enoxaparin in preventing venous thromboembolism in high risk blunt trauma patients. J Am Coll Surg. 2001 Feb;192(2):161-7. doi: 10.1016/s1072-7515(00)00802-4. |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002241 |
| Carbohydrates |