PREVENTion of Clot in Orthopaedic Trauma

(PREVENT CLOT Trial)

Recruiting at20 trial locations

Overseen by Renan Castillo, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Major Extremity Trauma Research Consortium

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Katherine Frey, PhD, MPH, RN

Principal Investigator

Johns Hopkins Bloomberg School of Public Health

Robert O'Toole, MD

Principal Investigator

University of Maryland

Renan Castillo, PhD

Principal Investigator

Johns Hopkins Bloomberg School of Public Health

Tara Taylor, MPH

Principal Investigator

Johns Hopkins Bloomberg School of Public Health

Eligibility Criteria

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.

Treatment Details

Interventions

• Acetylsalicylic acid (Antiplatelet Agent)
• Enoxaparin (Anticoagulant)

Participant Groups

Group I: Low Molecular Weight Heparin (LMWH)-Enoxaparin Active Control 1 Intervention

Injection of 30 mg enoxaparin, twice a day via injection

Group II: Acetylsalicylic acid (ASA)-Aspirin Active Control 1 Intervention

Enteral ingestion or administration of 81 mg ASA, twice a day

Who Is Running the Clinical Trial?

Major Extremity Trauma Research Consortium

Lead Sponsor

Trials

32

Recruited

27,400+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Nakela L. Cook

Patient-Centered Outcomes Research Institute

Chief Executive Officer since 2020

MD, MPH

Harv Feldman

Patient-Centered Outcomes Research Institute

Chief Medical Officer

MD, MSCE