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Active Clinical Trials

PREVENTion of Clot in Orthopaedic Trauma (PREVENT CLOT)

Active NCT:
02984384
Allegheny General Hospital
Allegheny General Hospital

Federal North Building
Federal North Building

Sponsor: 
Major Extremity Trauma Research Consortium
Contact: 

For more information, please contact Tracy Salopek by telephone at 412-359-8528 or email at Traci.Salopek@AHN.ORG.

PREVENTion of Clot in Orthopaedic Trauma (PREVENT CLOT): A Randomized Pragmatic Trial Comparing the Complications and Safety of Blood Clot Prevention Medicines Used in Orthopaedic Trauma Patients

Purpose: 

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.

Ages Eligible for Study:  18 Years and older   (Adult, Older Adult)

Sexes Eligible for Study:  All

Accepts Healthy Volunteers:  No

Inclusion Criteria:

Trauma patients who are at increased risk of blood clots from their orthopaedic traumatic injury (operatively treated extremity injuries and all pelvis or acetabulum fractures that are treated either operatively or non operatively) and for whom a prophylactic blood thinner regimen would be standard of care at their institution.

18 years or older

Exclusion Criteria:

Patients who present to the hospital more than 48 hours post injury

Patients who received more than 2 doses of LMWH or Aspirin for initial prophylaxis

Patients on long term blood thinners (other than low-dose aspirin or platelet inhibitors such as Plavix or Aggrenox)

Patients who have had a VTE within the last 6 months

Patients on therapeutic (as opposed to prophylactic) blood thinners for an acute issue at the time of admission

Patients who have a newly diagnosed indication for therapeutic blood thinners (for example vascular injury) that will require therapeutic anticoagulation for more than one week

Patients who cannot receive either of the study medications due to an allergy (history of heparin induced thrombocytopenia, allergy to aspirin, or NSAIDs) or other medical contraindication to blood thinners

Patients who are on higher dose aspirin (>81 mg once a day or higher) for medical reasons or who will be treated with higher dose aspirin

Patients with underlying chronic clotting disorders (i.e. Factor V Leiden, hyperhomocysteinemia, Protein C and S deficiency) that require full dose anticoagulation or are a contraindication to venous thromboembolism chemoprophylaxis

Patients with end stage renal disease or impaired creatinine clearance <30 ml/min at time of randomization(note: creatinine clearance does not need to be documented if prescribing physician would order medication without test as SOC)

Pregnant or lactating patients

Patients contraindicated for any reason for either medicine

Prisoners

Patients who do not speak either English or Spanish

Patients may be excluded for other reasons at the discretion of the treating physician; the reason for exclusion must be documented on the screening form.