CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 329 enrolled
Drug / intervention
VTE prophylaxis with Enoxaparin 30mg BID +1 moredrug
Likely dose
VTE prophylaxis with Enoxaparin 30mg BIDfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02774265
NCT02774265Phase 3Completed
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A Different Approach to Preventing Thrombosis (ADAPT): A Randomized Controlled Trial Comparing Low Molecular Weight Heparin to Acetylsalicylic Acid in Orthopedic Trauma Patients

University of Maryland, Baltimore·interventional·Posted May 17, 2016·Updated Jan 5, 2022

In Brief

A Phase 3 clinical trial evaluating VTE prophylaxis with Enoxaparin 30mg BID and VTE prophylaxis with Aspirin 81mg BID for Venous Thromboembolism and Pulmonary Embolism. Completed, enrolled 329 participants across 1 site.

Detailed Summary

The purpose of this study is to perform a pragmatic randomized controlled trial to compare the use of low molecular weight heparin (LMWH, lovenox, enoxaparin) versus acetylsalicylic acid (ASA) for venous thromboembolism (VTE) prophylaxis in patients with high-risk lower extremity fractures.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVenous Thromboembolism, Pulmonary Embolism
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 17, 2016
Enrollment StartJan 1, 2016
Primary CompletionMay 1, 2017
Study CompletionSep 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 10.1 years ago

Interventions

VTE prophylaxis with Enoxaparin 30mg BIDdrug

Patients will receive Enoxaparin 30mg BID for DVT prophylaxis and will be followed to determine the efficacy, safety and cost when used for VTE prophylaxis in high-risk orthopedic traumas administered for the length of time indicated by standard of care based on the injury.

VTE prophylaxis with Aspirin 81mg BIDdrug

Patients will receive Aspirin 81mg BID for DVT prophylaxis and will be followed to determine the efficacy, safety and cost when used for VTE prophylaxis in high-risk orthopedic traumas administered for the length of time indicated by standard of care based on the injury.