PREVENTion of Clot in Orthopaedic Trauma (NCT02984384) | Clinical Trial Compass
CompletedPhase 3
PREVENTion of Clot in Orthopaedic Trauma
United States12,424 participantsStarted 2017-04-24
Plain-language summary
The purpose of this study is to compare aspirin versus low-molecular weight heparin (LMWH) (Enoxaparin) as a thromboprophylaxis in patients who sustain a fracture.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients who have a planned operative or non-operative pelvis or acetabular fracture, or any operative extremity fracture proximal to the metatarsals or carpals.
* Patients at increased risk of blood clot(s) from their orthopaedic injury(ies) and will receive prophylactic blood thinner regimen per standard of care.
* Patients 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 VTE 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 …