Rotational Thromboelastometry Activated Transfusion In Trauma Trial

University of Texas Southwestern Medical Center31 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Trauma

Interventions

Thromboelastometry guided transfusionPROCEDURE

Comparing resuscitation strategies with standard MTP v.s. ROTEM guided MTP

Eligibility

Sex: ALLMin age: 14 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (1)

Parkland Memorial Hospital

Dallas, Texas, United States

Outcomes

Primary Outcomes

Change in number of blood products utilized at 24 hours

Number of blood products utilized during that time frame will be recorded to determine if change in resuscitation strategies result in measurable differences

Time frame: 24 hours from time of randomization

Secondary Outcomes

Change in coagulation profile

Analyze coagulation profiles in each resuscitation strategy to determine if there is a change in the mechanism of coagulopathy

Time frame: 0 hours and 30 days

Change in inflammatory mediators

Analyze inflammatory mediators in each resuscitation strategy to determine if there is a change in the mechanism of coagulopathy

Time frame: 0 hours and 30 days

Changes in Resuscitation strategy-related adverse events

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)

Time frame: 30 days after admission

Data from ClinicalTrials.gov

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