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Completed

NCT Number: NCT03765866

Rotational Thromboelastometry Activated Transfusion In Trauma Trial

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.

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Key information

Conditions

Trauma Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Hemostatic Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases Wounds and Injuries

Age range

14 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Parkland Memorial Hospital

Dallas, Texas, 75206, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thromboelastometry guided transfusion

Procedure

Comparing resuscitation strategies with standard MTP v.s. ROTEM guided MTP

Primary outcomes

  1. Change in number of blood products utilized at 24 hours

    Time frame: 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 outcomes

  1. Change in coagulation profile

    Time frame: 0 hours and 30 days

    Analyze coagulation profiles in each resuscitation strategy to determine if there is a change in the mechanism of coagulopathy

  2. Change in inflammatory mediators

    Time frame: 0 hours and 30 days

    Analyze inflammatory mediators in each resuscitation strategy to determine if there is a change in the mechanism of coagulopathy

  3. Changes in Resuscitation strategy-related adverse events

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

Viscoelastic Guided Goal Directed Resuscitation of Severely Injured Patients

Acronym: ROTATE-IT

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 5, 2018
Registry last updated
May 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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