Rotational Thromboelastometry Activated Transfusion In Trauma Trial

Study Overview
=================
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.

Official Title
-----------------
Viscoelastic Guided Goal Directed Resuscitation of Severely Injured Patients

Conditions
-----------------
Trauma

Intervention / Treatment
-----------------
* Procedure: Thromboelastometry guided transfusion


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Massive Transfusion Protocol Guided<br>Clinicians will only transfuse patients according to standard massive transfusion protocol (MTP) | |
| Experimental: Thromboelastometry guided transfusion<br>Clinicians will transfuse patients according to ROTEM results. | Procedure: Thromboelastometry guided transfusion<br>* Comparing resuscitation strategies with standard MTP v.s. ROTEM guided MTP<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rotational thromboelastometry, viscoelastic test, coagulopathy, trauma, hemorrhage