Last updated on May 2018

PREVENTion of Clot in Orthopaedic Trauma


Brief description of study

The purpose of this study is to investigate the effectiveness of Low Molecular Weight Heparin (LMWH) compared to Aspirin in preventing death and clinically important pulmonary blood clots in patients who sustain trauma.

Detailed Study Description

In this study the efficacy of Low Molecular Weight Heparin (LMWH) (Enoxaparin) compared to Aspirin in the use of preventing death and clinically important blood clots in the lungs in patients who sustain trauma will be investigated. The following comparisons between aspirin and the LMWH are described in the specific aims below:

Specific Aim 1: Assess the proportion of patients who sustain death, clinically significant pulmonary embolism, or complication after orthopaedic trauma treated with injectable LMWH compared to those treated with aspirin.

Hypothesis 1a: The mortality rate will be non-inferior in the aspirin group Hypothesis 1b: The rate of clinically significant PE will be non-inferior in the aspirin group Hypothesis 1c: The rate of complications will be superior (i.e., lower) in the aspirin group Specific Aim 2: Assess satisfaction with care in orthopaedic trauma patients treated with injectable LMWH compared to those treated with aspirin Hypothesis2a : Satisfaction will be superior in the aspirin group Specific Aim 3: Document out of pocket patient costs in orthopaedic trauma patients treated with injectable LMWH compared to those treated with aspirin Hypothesis3a : Out of pocket costs will be lower in the aspirin group Specific Aim 4: Examine the proportion of minor clot events that are less important to patients (clots in the proximal legs, incidental PE) in orthopaedic trauma patients treated with injectable LMWH compared to those treated with aspirin.

Hypothesis4a : The rate will be non-inferior in the aspirin group Specific Aim 5: Examine the proportion of minor clot events that are less important to patients (clots in the proximal legs, incidental PE) in orthopaedic trauma patients treated with injectable LMWH compared to those treated with aspirin.

Hypothesis 5a: The rate will be non-inferior in the aspirin group.

Clinical Study Identifier: NCT02984384

Contact Investigators or Research Sites near you

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Bellal Joseph, MD

University of Arizona
Tucson, AZ United States
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Tanya Zakrison, MD

University of Miami Ryder Trauma Center
Miami, FL United States
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Benjamin Zarzaur, MD

Methodist Hospital
Indianapolis, IN United States
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Deborah Stein, MD

University of Maryland R Adams Cowley Shock Trauma Center
Baltimore, MD United States
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George Velmahos, MD

Massachusetts General Hospital
Boston, MA United States
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Matthew Kutcher, MD

University of Mississippi Medical Center
Jackson, MS United States
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Kurt Rhynhart, MD

Dartmouth-Hitchcock Medical Center
Lebanon, NH United States
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Ashley Christmas, MD

Carolinas Medical Center
Charlotte, NC United States
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Preston Miller, MD

Wake Forest University Baptist Medical Center
Winston-Salem, NC United States
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Jeffery Claridge, MD

MetroHealth Medical Center
Cleveland, OH United States
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Stephanie Lueckal, MD

Rhode Island Hospital, Brown University
Providence, RI United States
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Martin Croce, MD

University of Tennessee, RegionOne Medical Center
Memphis, TN United States
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Oscar Guillamondegui, MD

Vanderbilt Medical Center
Nashville, TN United States
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Bryan Cotton, MD

University of Texas Health Science Center at Houston
Houston, TX United States
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Kurt Edwards, MD

San Antonio Military Medical Center
San Antonio, TX United States
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Joseph Cuschieri

Harborview Medical Center
Seattle, WA United States
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Paul McBeth, MD

University of Calgary, Foothills Medical Centre
Calgary, AB Canada
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Johal Herman, MD

McMaster University, Hamilton General Hospital
Hamilton, ON Canada
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Recruitment Status: Open


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