Overview

This trial is active, not recruiting.

Conditions venous thromboembolism, thromboprophylaxis, trauma
Treatments aspirin, enoxaparin
Phase phase 4
Sponsor University of Miami
Start date February 2016
End date May 2018
Trial size 800 participants
Trial identifier NCT02396732, 20140937

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Group will get both enoxaparin (standard of care) and aspirin (intervention).
aspirin
enoxaparin
(Active Comparator)
Group will get only enoxaparin (standard of care).
enoxaparin

Primary Outcomes

Measure
Venous thromboembolism
time frame: Patients will be followed throughout their hospitalization, estimated 1-2 months

Secondary Outcomes

Measure
Hypercoagulability
time frame: Patients will be followed throughout their hospitalization, estimated 1-2 months
Mortality
time frame: Patients will be followed throughout their hospitalization, estimated 1-2 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title The Role Of Combined Therapy With Aspirin and Enoxaparin In Prevention Of Venous Thromboembolism In Trauma Patients: A Randomized-Controlled Trial
Description This is a prospective, randomized, controlled, open-label clinical trial evaluating the effect of dual thromboprophylaxis with enoxaparin and aspirin versus enoxaparin alone on the incidence of VTE in trauma patients. Once a trauma patient is admitted to the Intensive Care Unit (ICU), study personnel will screen for entry criteria and, if eligible, will obtain informed consent from the patient or healthcare proxy. After informed consent, subjects will be randomized into one of 2 groups to receive either standard of care with enoxaparin alone (control group) or dual thromboprophylaxis with enoxaparin plus aspirin (intervention group). Alternative thromboprophylaxis will be permitted prior to consent or randomization or at anytime at the discretion of the attending physician for any reason. Standard drug dosages will be used (enoxaparin 30 mg subcutaneous twice daily; aspirin 81 mg oral daily). All consented subjects will be followed from admission until discharge from the hospital. Data collection will include demographic information, injury pattern, mechanism of injury, need for surgical intervention, admission and daily laboratory values (e.g. basic metabolic profile, complete blood count, coagulation studies, ROTEM), weekly venous duplex ultrasonography (VDU), admission and subsequent radiologic examinations, medication administration records (including missed doses of thromboprophylaxis), and outcomes measures (complications, VTE, mortality). Blood samples for complete blood count and coagulation studies will be ordered as medically necessary per the primary team; ROTEM samples will be taken pre-prophylaxis and post-prophylaxis and will be run in the Trauma Research Office. The amount drawn will not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection will not occur more frequently than 2 times per week. All clinical care will be at the discretion of the attending physician. Should the attending physician choose to change thromboprophylaxis medication, this will be permitted for the study and included in the data collection. Discontinuation of thromboprophylaxis generally occurs in a standardized fashion once the patient is fully ambulatory; however, should the attending physician stray from this regimen, it is permitted for the study and will be part of the data collection. For each patient admitted to the ICU and eligible for study participation, routine measures already obtained by clinical staff will be collected/calculated.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by University of Miami.