Aspirin and Enoxaparin for VTE in Trauma

NCT02396732 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: 20140937
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Venous Thromboembolism; Thromboprophylaxis; Trauma

Keywords

Aspirin; Enoxaparin; Thromboprophylaxis; Trauma; Venous thromboembolism

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Hypercoagulability

  Baseline, up to 2 months hospitalization

• Mortality

  Up to 2 months of hospitalization

Study Arms (2)

Low Molecular Weight Heparin (LMWH) + Aspirin (ASA)

EXPERIMENTAL

Group will get both enoxaparin (standard of care) and aspirin (intervention) after consent up to Intensive Care Unit (ICU) discharge.

Drug: Aspirin; Drug: Enoxaparin

Low Molecular Weight Heparin (LMWH) Alone

ACTIVE COMPARATOR

Group will get only enoxaparin (standard of care) after consent up to Intensive Care Unit (ICU) discharge.

Drug: Enoxaparin

Interventions

Aspirin DRUG

Daily dose is 81 mg oral tablet

Low Molecular Weight Heparin (LMWH) + Aspirin (ASA)

Enoxaparin DRUG

Daily dose is by subcutaneous injection and weight based at the discretion of the treating clinician.

Low Molecular Weight Heparin (LMWH) + Aspirin (ASA); Low Molecular Weight Heparin (LMWH) Alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

Ryder Trauma Center

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Venous Thromboembolism; Wounds and Injuries

Interventions

Aspirin; Enoxaparin

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Kenneth Proctor
• Organization: University of Miami

kproctor@med.miami.edu

305-585-1178

Study Officials

• Kenneth Proctor, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: March 12, 2015
• First Posted: March 24, 2015
• Study Start: February 1, 2016
• Primary Completion: May 15, 2018
• Study Completion: May 15, 2018
• Last Updated: November 19, 2019
• Results First Posted: November 19, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)