Viscoelastic Guided Goal Directed Resuscitation of Severely Injured Patients

Rotational Thromboelastometry Activated Transfusion In Trauma Trial

Sponsors

Lead sponsor: University of Texas Southwestern Medical Center

Source 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.

Overall Status Recruiting
Start Date May 2016
Completion Date May 2020
Primary Completion Date May 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in number of blood products utilized at 24 hours 24 hours from time of randomization
Secondary Outcome
Measure Time Frame
Change in coagulation profile 0 hours and 30 days
Change in inflammatory mediators 0 hours and 30 days
Changes in Resuscitation strategy-related adverse events 30 days after admission
Enrollment 100
Condition
Intervention

Intervention type: Procedure

Intervention name: Thromboelastometry guided transfusion

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

Arm group label: Thromboelastometry guided transfusion

Eligibility

Criteria:

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

Gender: All

Minimum age: 14 Years

Maximum age: 100 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Michael W. Cripps, M.D. Principal Investigator UT Southwestern Medical Center
Overall Contact

Last name: Michael W. Cripps, M.D.

Phone: 214-648-2708

Email: [email protected]

Location
facility status contact investigator
Parkland Memorial Hospital Recruiting Michael W Cripps, MD 214-648-2708 [email protected] Michael W Cripps, MD Principal Investigator
Location Countries

United States

Verification Date

May 2020

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Massive Transfusion Protocol Guided

Arm group type: No Intervention

Description: Clinicians will only transfuse patients according to standard massive transfusion protocol (MTP)

Arm group label: Thromboelastometry guided transfusion

Arm group type: Experimental

Description: Clinicians will transfuse patients according to ROTEM results.

Acronym ROTATE-IT
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov