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PREVENTion of Clot in Orthopaedic Trauma

NCT02984384 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 12424

Last updated 2024-05-14

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Patient-Centered Outcomes Research Institute

    collaborator OTHER

  • Major Extremity Trauma Research Consortium

    lead OTHER

Principal Investigators

  • Robert O'Toole, MD · University of Maryland

  • Renan Castillo, PhD · Johns Hopkins Bloomberg School of Public Health

  • Tara Taylor, MPH · Johns Hopkins Bloomberg School of Public Health

  • Katherine Frey, PhD, MPH, RN · Johns Hopkins Bloomberg School of Public Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-24
Primary Completion
2022-02-18
Completion
2022-02-18
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02984384 on ClinicalTrials.gov