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

The University of Texas System (UT)

Status: Completed

Conditions: Trauma

Treatments: Procedure: Thromboelastometry guided transfusion

Study type: Interventional

Funder types: Other

Identifiers

NCT03765866

022015-093

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 14 to 100 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 2 patient groups

Massive Transfusion Protocol Guided

No Intervention group

Description:

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

Thromboelastometry guided transfusion

Experimental group

Description:

Clinicians will transfuse patients according to ROTEM results.

Treatment:

Procedure: Thromboelastometry guided transfusion