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Hospitalized trauma patients frequently suffer from blood clots in the legs or lungs. To minimize the risk of these blood clots developing, patients may be given a blood-thinner drug such as enoxaparin.
Until now, a set dose of enoxaparin has been given to a patient, regardless of his or her weight. However, a recent study suggests that for obese patients, the set dose may be inadequate. The purpose of this study is to evaluate whether or not a dose of enoxaparin that is based on the patient's weight will help to prevent the formation of blood clots.
The information gathered through this study will help doctors to understand the best way to prevent blood clots in future trauma patients. The potential risks of participating in this study include the minor risks of blood draws and ultrasounds, as well as the more significant risks of bleeding as a side effect of the enoxaparin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Dosing | Active Comparator | Patients will receive standard VTE prophylaxis of enoxaparin SQ every 12 hours. |
|
| Weight Based Dosing | Experimental | Patients will receive weight adjusted VTE prophylaxis of enoxaparin SQ every 12 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dosing of enoxaparin for VTE prophylaxis | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Asymptomatic lower-extremity DVT identified during hospitalization | Hospitalization |
| Measure | Description | Time Frame |
|---|---|---|
| Symptomatic lower extremity DVT during hospitalization and at 90 days | 90 Days | |
| Asymptomatic proximal DVT during hospitalization | Hospitalization | |
| Symptomatic proximal DVT during hospitalization and at 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intermountain Medical Center | Murray | Utah | 84157-7000 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15136370 | Background | Mosen D, Elliott CG, Egger MJ, Mundorff M, Hopkins J, Patterson R, Gardner RM. The effect of a computerized reminder system on the prevention of postoperative venous thromboembolism. Chest. 2004 May;125(5):1635-41. doi: 10.1378/chest.125.5.1635. | |
| 15758007 | Background | Kucher N, Koo S, Quiroz R, Cooper JM, Paterno MD, Soukonnikov B, Goldhaber SZ. Electronic alerts to prevent venous thromboembolism among hospitalized patients. N Engl J Med. 2005 Mar 10;352(10):969-77. doi: 10.1056/NEJMoa041533. |
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| 90 Days |
| Symptomatic upper-extremity DVT during hospitalization and at 90 days | 90 Days |
| Symptomatic PE during hospitalization and at 90 Days | 90 Days |
| Major Bleeding | Major Bleeding as defined by the criteria of the International Society of Thrombosis. | Hospitalization and at 90 Days |
| 11115458 | Background | Goldhaber SZ, Dunn K, MacDougall RC. New onset of venous thromboembolism among hospitalized patients at Brigham and Women's Hospital is caused more often by prophylaxis failure than by withholding treatment. Chest. 2000 Dec;118(6):1680-4. doi: 10.1378/chest.118.6.1680. |
| 17095499 | Background | Khouli H, Shapiro J, Pham VP, Arfaei A, Esan O, Jean R, Homel P. Efficacy of deep venous thrombosis prophylaxis in the medical intensive care unit. J Intensive Care Med. 2006 Nov-Dec;21(6):352-8. doi: 10.1177/0885066606292880. |
| 16439370 | Background | Cohen AT, Davidson BL, Gallus AS, Lassen MR, Prins MH, Tomkowski W, Turpie AG, Egberts JF, Lensing AW; ARTEMIS Investigators. Efficacy and safety of fondaparinux for the prevention of venous thromboembolism in older acute medical patients: randomised placebo controlled trial. BMJ. 2006 Feb 11;332(7537):325-9. doi: 10.1136/bmj.38733.466748.7C. Epub 2006 Jan 26. |
| 10477777 | Background | Samama MM, Cohen AT, Darmon JY, Desjardins L, Eldor A, Janbon C, Leizorovicz A, Nguyen H, Olsson CG, Turpie AG, Weisslinger N. A comparison of enoxaparin with placebo for the prevention of venous thromboembolism in acutely ill medical patients. Prophylaxis in Medical Patients with Enoxaparin Study Group. N Engl J Med. 1999 Sep 9;341(11):793-800. doi: 10.1056/NEJM199909093411103. |
| 15289368 | Background | Leizorovicz A, Cohen AT, Turpie AG, Olsson CG, Vaitkus PT, Goldhaber SZ; PREVENT Medical Thromboprophylaxis Study Group. Randomized, placebo-controlled trial of dalteparin for the prevention of venous thromboembolism in acutely ill medical patients. Circulation. 2004 Aug 17;110(7):874-9. doi: 10.1161/01.CIR.0000138928.83266.24. Epub 2004 Aug 2. |
| 17310052 | Background | Dentali F, Douketis JD, Gianni M, Lim W, Crowther MA. Meta-analysis: anticoagulant prophylaxis to prevent symptomatic venous thromboembolism in hospitalized medical patients. Ann Intern Med. 2007 Feb 20;146(4):278-88. doi: 10.7326/0003-4819-146-4-200702200-00007. |
| 17409325 | Background | Francis CW. Clinical practice. Prophylaxis for thromboembolism in hospitalized medical patients. N Engl J Med. 2007 Apr 5;356(14):1438-44. doi: 10.1056/NEJMcp067264. No abstract available. |
| 16100192 | Background | Spyropoulos AC. Emerging strategies in the prevention of venous thromboembolism in hospitalized medical patients. Chest. 2005 Aug;128(2):958-69. doi: 10.1378/chest.128.2.958. |
| 11742929 | Background | Arnold DM, Kahn SR, Shrier I. Missed opportunities for prevention of venous thromboembolism: an evaluation of the use of thromboprophylaxis guidelines. Chest. 2001 Dec;120(6):1964-71. doi: 10.1378/chest.120.6.1964. |
| 17573514 | Background | Tapson VF, Decousus H, Pini M, Chong BH, Froehlich JB, Monreal M, Spyropoulos AC, Merli GJ, Zotz RB, Bergmann JF, Pavanello R, Turpie AG, Nakamura M, Piovella F, Kakkar AK, Spencer FA, Fitzgerald G, Anderson FA Jr; IMPROVE Investigators. Venous thromboembolism prophylaxis in acutely ill hospitalized medical patients: findings from the International Medical Prevention Registry on Venous Thromboembolism. Chest. 2007 Sep;132(3):936-45. doi: 10.1378/chest.06-2993. Epub 2007 Jun 15. |
| 16516275 | Background | Kahn SR, Panju A, Geerts W, Pineo GF, Desjardins L, Turpie AG, Glezer S, Thabane L, Sebaldt RJ; CURVE study investigators. Multicenter evaluation of the use of venous thromboembolism prophylaxis in acutely ill medical patients in Canada. Thromb Res. 2007;119(2):145-55. doi: 10.1016/j.thromres.2006.01.011. Epub 2006 Mar 3. |
| 21108553 | Background | Freeman AL, Pendleton RC, Rondina MT. Prevention of venous thromboembolism in obesity. Expert Rev Cardiovasc Ther. 2010 Dec;8(12):1711-21. doi: 10.1586/erc.10.160. |
| 19272635 | Background | Rondina MT, Wheeler M, Rodgers GM, Draper L, Pendleton RC. Weight-based dosing of enoxaparin for VTE prophylaxis in morbidly obese, medically-Ill patients. Thromb Res. 2010 Mar;125(3):220-3. doi: 10.1016/j.thromres.2009.02.003. Epub 2009 Mar 9. |
| 8703169 | Background | Geerts WH, Jay RM, Code KI, Chen E, Szalai JP, Saibil EA, Hamilton PA. A comparison of low-dose heparin with low-molecular-weight heparin as prophylaxis against venous thromboembolism after major trauma. N Engl J Med. 1996 Sep 5;335(10):701-7. doi: 10.1056/NEJM199609053351003. |