Aspirin and Enoxaparin for VTE in Trauma

Phase 4

Terminated

• Conditions: Thromboprophylaxis; Trauma; Venous Thromboembolism
• Interventions: Drug: Aspirin; Drug: Enoxaparin

• Registration Number: NCT02396732
• Lead Sponsor: University of Miami

Brief Summary

The purpose of this study is to determine if the addition of antiplatelet therapy (i.e. aspirin) to low-molecular-weight-heparin (i.e. enoxaparin) will decrease the incidence of venous thromboembolism (VTE) in high-risk critically injured patients. The investigators further aim to determine the safety and efficacy of dual thromboprophylaxis with aspirin and enoxaparin for decreasing the incidence of VTE after trauma.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-12
• Study First Submitted QC: 2015-03-17
• Study First Posted: 2015-03-24
• Study Start: 2016-02
• Primary Completion: 2018-05-15
• Study Completion: 2018-05-15
• Status Verified: 2019-10
• Results First Submitted: 2019-10-26
• Results First Submitted QC: 2019-10-31
• Last Update Submitted: 2019-10-31
• Results First Posted: 2019-11-19
• Last Update Posted: 2019-11-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• Age 18 years or older
• Blunt or penetrating trauma
• Requires VTE thromboprophylaxis
• High-risk for VTE

Exclusion Criteria

• Presence of VTE upon admission
• Pregnant or nursing
• Inability to give informed consent by patient or healthcare proxy
• Contraindication to enoxaparin
• Contraindication to aspirin
• Epidural or subdural hematoma
• Presence, or removal within the last 12 hours, of an epidural or spinal catheter, or recent (within the last 12 hours) epidural or spinal anesthesia/procedures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Molecular Weight Heparin (LMWH) + Aspirin (ASA)	Aspirin	Group will get both enoxaparin (standard of care) and aspirin (intervention) after consent up to Intensive Care Unit (ICU) discharge.
Low Molecular Weight Heparin (LMWH) + Aspirin (ASA)	Enoxaparin	Group will get both enoxaparin (standard of care) and aspirin (intervention) after consent up to Intensive Care Unit (ICU) discharge.
Low Molecular Weight Heparin (LMWH) Alone	Enoxaparin	Group will get only enoxaparin (standard of care) after consent up to Intensive Care Unit (ICU) discharge.

Primary Outcome Measures

Name	Time	Method
Incidence of Venous Thromboembolism	Up to 2 months of hospitalization	Incidence of VTE is defined as new cases reported of: 1. Deep Vein Thrombosis (DVT), symptomatic or asymptomatic as assessed via venous duplex ultrasonography, and 2. Pulmonary Embolism (PE), symptomatic or asymptomatic as assessed via chest computed tomography with angiography (CTA) or ventilation-perfusion (VQ) Scan

Secondary Outcome Measures

Name	Time	Method
Change in Hypercoagulability	Baseline, up to 2 months hospitalization	Assessed via the combination of routine laboratory values (Prothrombin Time and Partial Thromboplastin Time) evaluated through weekly thromboelastography (TEG)
Mortality	Up to 2 months of hospitalization	Mortality will be reported as the number of participants with reported death upon hospital discharge

Trial Locations

Locations (1)

Ryder Trauma Center; 🇺🇸 Miami, Florida, United States