Antithrombin to Improve Thromboprophylaxis and Reduce the Incidence of Trauma-Related Venous Thromboembolism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE2

Total Enrollment

314 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-27

Study Completion Date

2027-03-31

Brief Summary

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The purpose of this study is to determine if additional interventions will assist with decreasing the risk and/or severity of thromboembolism (clotting complications) in patients who have experienced a major traumatic event.

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Detailed Description

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Conditions

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Trauma Injury Thromboembolism Venous Thromboembolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Multi-center, placebo-controlled, randomized, double-blind study

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

This will be a double-blind study.

Study Groups

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Thrombate infusion

Group Type EXPERIMENTAL

Thrombate infusion

Intervention Type DRUG

Bolus intravenous infusion of Thrombate will be given to achieve antithrombin (AT) activity levels at 150% before the 3rd dose of Enoxaparin. The dose will be based on patient weight.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Normal Saline will be given as one time IV before the 3rd dose of Enoxaparin. The dose will be based on patient weight.

Interventions

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Thrombate infusion

Bolus intravenous infusion of Thrombate will be given to achieve antithrombin (AT) activity levels at 150% before the 3rd dose of Enoxaparin. The dose will be based on patient weight.

Intervention Type DRUG

Placebo

Normal Saline will be given as one time IV before the 3rd dose of Enoxaparin. The dose will be based on patient weight.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Admission to trauma service
* Polytraumatic injuries OR pelvic/long bone fracture
* Planned admission to trauma ICU or step-down/SIMU setting (this includes STICU, SIMU/TIMU, BICU, and BIMU)
* Informed consent obtained

Exclusion Criteria

* Prisoners (defined as those directly admitted from correctional facility)
* Known or suspected pregnancy
* ≥ 20% total body surface area (TBSA) burned
* Nonsurvivable head injuries
* Known hematologic or immunologic disorders
* Known prehospital anticoagulant use
* Patients initially placed on unfractionated heparin for thromboprophylaxis
* Known allergy to Antithrombin or it's components
* Enrollment in another interventional study unless approved by Trial Principal Investigator

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No