Rotational Thromboelastometry Activated Transfusion In Trauma Trial

Not Applicable

Completed

• Conditions: Trauma
• Interventions: Procedure: Thromboelastometry guided transfusion

• Registration Number: NCT03765866
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

This is a randomized controlled trial to compare viscoelastic (VE) guided resuscitation to fixed-ratio resuscitation in trauma patients with hemorrhagic shock on the utilization of blood products, effects on coagulation and inflammatory mediators, and how these strategies affect post resuscitation adverse events.

Detailed Description

This is an open labeled study as the VE guided resuscitation will be based on the visible VE results. Aim 1 will compare the number of blood products utilized in each resuscitation strategy. Aim 2 will analyze the coagulation and inflammatory mediators in each resuscitation strategy to determine if there is a difference in the mechanism of coagulopathy. Aim 3 will determine if the different resuscitation strategies have an effect on post resuscitation adverse events.

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-23
• Study First Submitted QC: 2018-12-03
• Study First Posted: 2018-12-05
• Primary Completion: 2018-12-17
• Study Completion: 2018-12-17
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-27
• Last Update Posted: 2020-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

1. Trauma patient
2. MTP Activation
3. Only patients ≥ 14 years old
4. Alive at 31 mins after arrival in ED

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Exclusion Criteria

1. Transfer from OSH
2. Received CPR for more than 5 mins
3. Burned
4. Pregnant or Prisoner
5. Known DNR
6. Jehovah's witness

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thromboelastometry guided transfusion	Thromboelastometry guided transfusion	Clinicians will transfuse patients according to ROTEM results.

Primary Outcome Measures

Name	Time	Method
Change in number of blood products utilized at 24 hours	24 hours from time of randomization	Number of blood products utilized during that time frame will be recorded to determine if change in resuscitation strategies result in measurable differences

Secondary Outcome Measures

Name	Time	Method
Change in coagulation profile	0 hours and 30 days	Analyze coagulation profiles in each resuscitation strategy to determine if there is a change in the mechanism of coagulopathy
Change in inflammatory mediators	0 hours and 30 days	Analyze inflammatory mediators in each resuscitation strategy to determine if there is a change in the mechanism of coagulopathy
Changes in Resuscitation strategy-related adverse events	30 days after admission	Rate of resuscitation strategies-related adverse events as a composite, including (transfusion related acute lung injury, transfusion associated circulatory overload, hyperkalemia, hypocalcemia, allergic reaction, hemolysis and transfusion transmitted infection)

Trial Locations

Locations (1)

Parkland Memorial Hospital; 🇺🇸 Dallas, Texas, United States