Rotational Thromboelastometry Activated Transfusion In Trauma Trial
ROTATE-IT
Viscoelastic Guided Goal Directed Resuscitation of Severely Injured Patients
1 other identifier
interventional
31
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 23, 2016
CompletedFirst Posted
Study publicly available on registry
December 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 17, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 17, 2018
CompletedMay 29, 2020
May 1, 2020
2.6 years
May 23, 2016
May 27, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
24 hours from time of randomization
Secondary Outcomes (3)
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
Study Arms (2)
Massive Transfusion Protocol Guided
NO INTERVENTIONClinicians will only transfuse patients according to standard massive transfusion protocol (MTP)
Thromboelastometry guided transfusion
EXPERIMENTALClinicians will transfuse patients according to ROTEM results.
Interventions
Comparing resuscitation strategies with standard MTP v.s. ROTEM guided MTP
Eligibility Criteria
You may qualify if:
- Trauma patient
- MTP Activation
- Only patients ≥ 14 years old
- Alive at 31 mins after arrival in ED
You may not qualify if:
- Transfer from OSH
- Received CPR for more than 5 mins
- Burned
- Pregnant or Prisoner
- Known DNR
- Jehovah's witness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Parkland Memorial Hospital
Dallas, Texas, 75206, United States
Related Publications (1)
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.
PMID: 24103457BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael W. Cripps, M.D.
University of Texas Southwestern Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2016
First Posted
December 5, 2018
Study Start
May 1, 2016
Primary Completion
December 17, 2018
Study Completion
December 17, 2018
Last Updated
May 29, 2020
Record last verified: 2020-05