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

Find a site near you

Start Over