Rotational Thromboelastometry Activated Transfusion In Trauma Trial

Trauma Clinical Trial

— ROTATE-IT  

Official title:

Viscoelastic Guided Goal Directed Resuscitation of Severely Injured Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03765866
• Other study ID #: 022015-093
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: December 17, 2018

Study information

• Verified date: May 2020
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: December 17, 2018
• Est. primary completion date: December 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Trauma
• Wounds and Injuries

Intervention

Procedure:
• Thromboelastometry guided transfusion
Comparing resuscitation strategies with standard MTP v.s. ROTEM guided MTP

Locations

Country	Name	City	State
United States	Parkland Memorial Hospital	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

Schlimp CJ, Voelckel W, Inaba K, Maegele M, Schöchl 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in coagulation profile	Analyze coagulation profiles in each resuscitation strategy to determine if there is a change in the mechanism of coagulopathy	0 hours and 30 days
Secondary	Change in inflammatory mediators	Analyze inflammatory mediators in each resuscitation strategy to determine if there is a change in the mechanism of coagulopathy	0 hours and 30 days
Secondary	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)	30 days after admission