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

Primary Purpose

Trauma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Thromboelastometry guided transfusion
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trauma focused on measuring rotational thromboelastometry, viscoelastic test, coagulopathy, trauma, hemorrhage

Eligibility Criteria

14 Years - 100 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Parkland Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Massive Transfusion Protocol Guided

Thromboelastometry guided transfusion

Arm Description

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

Clinicians will transfuse patients according to ROTEM results.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in coagulation profile
Analyze coagulation profiles in each resuscitation strategy to determine if there is a change in the mechanism of coagulopathy
Change in inflammatory mediators
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
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)

Full Information

First Posted
May 23, 2016
Last Updated
May 27, 2020
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03765866
Brief Title
Rotational Thromboelastometry Activated Transfusion In Trauma Trial
Acronym
ROTATE-IT
Official Title
Viscoelastic Guided Goal Directed Resuscitation of Severely Injured Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
December 17, 2018 (Actual)
Study Completion Date
December 17, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma
Keywords
rotational thromboelastometry, viscoelastic test, coagulopathy, trauma, hemorrhage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Massive Transfusion Protocol Guided
Arm Type
No Intervention
Arm Description
Clinicians will only transfuse patients according to standard massive transfusion protocol (MTP)
Arm Title
Thromboelastometry guided transfusion
Arm Type
Experimental
Arm Description
Clinicians will transfuse patients according to ROTEM results.
Intervention Type
Procedure
Intervention Name(s)
Thromboelastometry guided transfusion
Intervention Description
Comparing resuscitation strategies with standard MTP v.s. ROTEM guided MTP
Primary Outcome Measure Information:
Title
Change in number of blood products utilized at 24 hours
Description
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 Outcome Measure Information:
Title
Change in coagulation profile
Description
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
Title
Change in inflammatory mediators
Description
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
Title
Changes in Resuscitation strategy-related adverse events
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Trauma patient MTP Activation Only patients ≥ 14 years old Alive at 31 mins after arrival in ED Exclusion Criteria: Transfer from OSH Received CPR for more than 5 mins Burned Pregnant or Prisoner Known DNR Jehovah's witness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael W. Cripps, M.D.
Organizational Affiliation
UT Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Parkland Memorial Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75206
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24103457
Citation
Schlimp CJ, Voelckel W, Inaba K, Maegele M, Schochl H. Impact of fibrinogen concentrate alone or with prothrombin complex concentrate (+/- fresh frozen plasma) on plasma fibrinogen level and fibrin-based clot strength (FIBTEM) in major trauma: a retrospective study. Scand J Trauma Resusc Emerg Med. 2013 Oct 8;21:74. doi: 10.1186/1757-7241-21-74.
Results Reference
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Rotational Thromboelastometry Activated Transfusion In Trauma Trial

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