Rotational Thromboelastometry Activated Transfusion In Trauma Trial (ROTATE-IT)

May 27, 2020 updated by: University of Texas Southwestern Medical Center

Viscoelastic Guided Goal Directed Resuscitation of Severely Injured Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75206
        • Parkland Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 100 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Massive Transfusion Protocol Guided
Clinicians will only transfuse patients according to standard massive transfusion protocol (MTP)
EXPERIMENTAL: Thromboelastometry guided transfusion
Clinicians will transfuse patients according to ROTEM results.
Procedure: Thromboelastometry guided transfusion
Comparing resuscitation strategies with standard MTP v.s. ROTEM guided MTP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in number of blood products utilized at 24 hours
Time Frame: 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
24 hours from time of randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in coagulation profile
Time Frame: 0 hours and 30 days
Analyze coagulation profiles in each resuscitation strategy to determine if there is a change in the mechanism of coagulopathy
0 hours and 30 days
Change in inflammatory mediators
Time Frame: 0 hours and 30 days
Analyze inflammatory mediators in each resuscitation strategy to determine if there is a change in the mechanism of coagulopathy
0 hours and 30 days
Changes in Resuscitation strategy-related adverse events
Time Frame: 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)
30 days after admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Investigators

  • Principal Investigator: Michael W. Cripps, M.D., UT Southwestern Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (ACTUAL)

December 17, 2018

Study Completion (ACTUAL)

December 17, 2018

Study Registration Dates

First Submitted

May 23, 2016

First Submitted That Met QC Criteria

December 3, 2018

First Posted (ACTUAL)

December 5, 2018

Study Record Updates

Last Update Posted (ACTUAL)

May 29, 2020

Last Update Submitted That Met QC Criteria

May 27, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 022015-093

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Trauma

Clinical Trials on Thromboelastometry guided transfusion

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahamas

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe