NCT02984384

PREVENTion of Clot in Orthopaedic Trauma

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 12,424 (actual)
• Sponsor: Major Extremity Trauma Research Consortium · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients who sustain orthopaedic trauma are at an increased risk of venous thromboembolism (VTE), including fatal pulmonary embolism (PE). Current guidelines recommend low-molecular-weight heparin (LMWH) for VTE prophylaxis in orthopaedic trauma patients. However, emerging literature in total joint arthroplasty patients suggests the potential clinical benefits of VTE prophylaxis with aspirin. This trial aims to determine if aspirin is non-inferior to LMWH for thromboprophylaxis in fracture patients.

Conditions

• Blood Clot
• Trauma

Interventions

Type	Name	Description
DRUG	Acetylsalicylic acid	The Aspirin intervention will be 81 mg enteral (by mouth, feeding tube or rectal) twice a day with no variation in dosing allowed.
DRUG	Low Molecular Weight Heparin (LMWH)	The LMWH intervention will be 30 mg enoxaparin subcutaneous (under the skin) twice a day with variations in dosing allowed, per the standard of care at sites, as needed for patients who are very obese or exhibit renal dysfunction.

Timeline

• Start date: 2017-04-24
• Primary completion: 2022-02-18
• Completion: 2022-02-18
• First posted: 2016-12-06
• Last updated: 2024-05-14
• Results posted: 2024-05-14

Locations

21 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study