Clinical trial

Evaluation of Chemical Venous Thromboembolism Prophylaxis in Trauma

Name
028.PHA.2022.D
Description
Venous thromboembolism (VTE) causes up to 100,000 deaths annually. Between 10%-30% of patients die within one month of VTE diagnosis, while survivors remain at increased risk for VTE recurrence or other complications like post-thrombotic syndrome or chronic pulmonary hypertension in the following decade. Trauma patients have many risk factors that predispose them to a VTE. During the first 48 hours after blunt trauma, patients are prothrombotic due to the release of procoagulant factors, have excessive thrombin generation due to extensive tissue and vascular injury, and have reduced circulation of endogenous anticoagulants like protein C.
Trial arms
Trial start
2023-07-21
Estimated PCD
2024-08-31
Trial end
2024-08-31
Treatment
enoxaparin
dose of enoxaparin at 48 hours post-VTE prophylaxis initiation
Arms:
LMWH dosing strategies
Other names:
Accessing for contraindication for chemical VTE prophylaxis
Size
100
Primary endpoint
Episodes of clinically significant bleeding after VTE prophylaxis initiation
"48 Hours"
Time to clinically significant bleeding after VTE prophylaxis initiation
"48 Hours"
Eligibility criteria
Inclusion Criteria: * ≥18 years of age * Admitted to the trauma service between October 1,2021 and March 31, 2022 * Weight ≥50 kg * Received chemical VTE prophylaxis with LMWH for at least 48 hours * At "high risk" or "very high risk" of VTE8 Exclusion Criteria: * Death, discharge, or hospice within 48 hours of admission * Documented heparin allergy (heparin-induced thrombocytopenia) * Indication for therapeutic anticoagulation, either prior to admission or during hospitalization * Prisoners * \<18 years of age * Pregnancy
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2023-09-06

1 organization

1 product

2 indications

Product
enoxaparin
Indication
Thromboembolism
Indication
Venous