Aspirin and Enoxaparin for VTE in Trauma

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2018-05-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Venous Thromboembolism Thromboprophylaxis Trauma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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

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

Group Type EXPERIMENTAL

Aspirin

Intervention Type DRUG

Daily dose is 81 mg oral tablet

Enoxaparin

Intervention Type DRUG

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

Low Molecular Weight Heparin (LMWH) Alone

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

Group Type ACTIVE_COMPARATOR

Enoxaparin

Intervention Type DRUG

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

Interventions

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Aspirin

Daily dose is 81 mg oral tablet

Intervention Type DRUG

Enoxaparin

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No