Aspirin and Enoxaparin for VTE in Trauma

Trauma Clinical Trial

Official title:

The Role Of Combined Therapy With Aspirin and Enoxaparin In Prevention Of Venous Thromboembolism In Trauma Patients: A Randomized-Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02396732
• Other study ID #: 20140937
• Status: Terminated
• Phase: Phase 4
• Start date: February 2016
• Est. completion date: May 15, 2018

Study information

• Verified date: October 2019
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: May 15, 2018
• Est. primary completion date: May 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thromboembolism
• Thromboprophylaxis
• Trauma
• Venous Thromboembolism
• Wounds and Injuries

Intervention

Drug:
• Aspirin
Daily dose is 81 mg oral tablet
• Enoxaparin
Daily dose is by subcutaneous injection and weight based at the discretion of the treating clinician.

Locations

Country	Name	City	State
United States	Ryder Trauma Center	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Venous Thromboembolism	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	Up to 2 months of hospitalization
Secondary	Change in Hypercoagulability	Assessed via the combination of routine laboratory values (Prothrombin Time and Partial Thromboplastin Time) evaluated through weekly thromboelastography (TEG)	Baseline, up to 2 months hospitalization
Secondary	Mortality	Mortality will be reported as the number of participants with reported death upon hospital discharge	Up to 2 months of hospitalization