Aspirin and Enoxaparin for VTE in Trauma

University of Miami

Status and phase: Terminated; Phase 4

Conditions: Venous Thromboembolism; Trauma; Thromboprophylaxis

Treatments: Drug: Aspirin; Drug: Enoxaparin

Study type: Interventional

Funder types: Other

Identifiers

NCT02396732

20140937

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 2 patient groups

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

Experimental group

Description:

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

Treatment:

Drug: Enoxaparin

Drug: Aspirin

Low Molecular Weight Heparin (LMWH) Alone

Active Comparator group

Description:

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

Treatment:

Drug: Enoxaparin