Trauma
Conditions
Keywords
rotational thromboelastometry, viscoelastic test, coagulopathy, trauma, hemorrhage
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.
Interventions
PROCEDUREThromboelastometry guided transfusion
Comparing resuscitation strategies with standard MTP v.s. ROTEM guided MTP
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in number of blood products utilized at 24 hours | 24 hours from time of randomization | Number of blood products utilized during that time frame will be recorded to determine if change in resuscitation strategies result in measurable differences |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in coagulation profile | 0 hours and 30 days | Analyze coagulation profiles in each resuscitation strategy to determine if there is a change in the mechanism of coagulopathy |
| Change in inflammatory mediators | 0 hours and 30 days | 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 | 30 days after admission | 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) |
Countries
United States
Outcome results
None listed