Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
PHASE4
Total Enrollment
1200 participants
Study Classification
INTERVENTIONAL
Study Start Date
2013-07-31
Study Completion Date
2017-12-31
Brief Summary
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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.
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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Detailed Description
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Conditions
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Venous Thromboembolism
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
PREVENTION
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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Standard Dosing
Patients will receive standard VTE prophylaxis of enoxaparin SQ every 12 hours.
Group Type
ACTIVE_COMPARATOR
Dosing of enoxaparin for VTE prophylaxis
Intervention Type
DRUG
Weight Based Dosing
Patients will receive weight adjusted VTE prophylaxis of enoxaparin SQ every 12 hours.
Group Type
EXPERIMENTAL
Dosing of enoxaparin for VTE prophylaxis
Intervention Type
DRUG
Interventions
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Dosing of enoxaparin for VTE prophylaxis
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* 18 years of age or older
* Body Weight \>60 kg
* Admitted to the trauma services at Intermountain Medical Center
* Have received 1 standard dose of enoxaparin for VTE prophylaxis during current hospital admission.
* Body Weight \>60 kg
* Admitted to the trauma services at Intermountain Medical Center
* Have received 1 standard dose of enoxaparin for VTE prophylaxis during current hospital admission.
Exclusion Criteria
* Significant bleeding injury such as solid organ laceration or intracranial bleed at discretion of attending physician
* Renal insufficiency (GFR \<30)
* Platelet count \<100 thousand per cubic ml
* Hypersensitivity to heparin or prior documented heparin induced thrombocytopenia (HIT) by patient report or in medical record
* Pregnant or breast feeding
* Hemorrhagic stroke in proceeding 3 months
* abnormal baseline coagulation characterized by an INR \>1.4, obtained at the discretion of the treating clinician
* Required therapeutic anticoagulation for atrial fibrillation, prior VTE, or mechanical heart valve
* Treatment with concomitant antiplatelet agent other than aspirin 326 mg or more daily
* Subjects with a life expectancy less than 1 month
* Subjects hospitalized more than 72 hours prior to randomization.
* Renal insufficiency (GFR \<30)
* Platelet count \<100 thousand per cubic ml
* Hypersensitivity to heparin or prior documented heparin induced thrombocytopenia (HIT) by patient report or in medical record
* Pregnant or breast feeding
* Hemorrhagic stroke in proceeding 3 months
* abnormal baseline coagulation characterized by an INR \>1.4, obtained at the discretion of the treating clinician
* Required therapeutic anticoagulation for atrial fibrillation, prior VTE, or mechanical heart valve
* Treatment with concomitant antiplatelet agent other than aspirin 326 mg or more daily
* Subjects with a life expectancy less than 1 month
* Subjects hospitalized more than 72 hours prior to randomization.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Intermountain Health Care, Inc.
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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Intermountain Medical Center
Murray, Utah, United States
Site Status
Countries
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United States
References
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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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
BACKGROUND
Other Identifiers
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WEBet-664-1a
Identifier Type: -
Identifier Source: org_study_id
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