COMPLETED

Type O Whole Blood and Assessment of Age During Prehospital Resuscitation Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Open label, multi-center, pre-hospital randomized trial utilizing 10 level-1 trauma centers designed to determine the efficacy and safety of low titer whole blood resuscitation as compared to standard of care resuscitation in patients at risk of hemorrhagic shock and to appropriately characterize the hemostatic competency of whole blood relative to its age.

Official Title

Type O Whole Blood and Assessment of Age During Prehospital Resuscitation (TOWAR) Trial

Quick Facts

Study Start:2022-04-19
Study Completion:2025-08-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT04684719

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 89 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1.) Injured patients at risk of hemorrhagic shock being transported from scene or referral hospital to a participating TOWAR trial site that meet requirements for initiation of blood or blood component transfusion
  1. 1. Wearing NO TOWAR opt-out bracelet
  2. 2. Age \> 90 or \< 18 years of age
  3. 3. Isolated fall from standing injury mechanism
  4. 4. Known prisoner or known pregnancy
  5. 5. Traumatic arrest with \> 5 minutes of CPR without return of vital signs
  6. 6. Brain matter exposed or penetrating brain injury (GSW)
  7. 7. Isolated drowning or hanging victims
  8. 8. Objection to study voiced by subject or family member at the scene
  9. 9. Inability to obtain IV or intraosseous access
  10. 10. Isolated burns without evidence of traumatic injury

Contacts and Locations

Principal Investigator

Jason L Sperry, MD
PRINCIPAL_INVESTIGATOR
University of Pittsburgh

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
University of Louisville
Louisville, Kentucky, 40292
United States
University of Mississippi Medical Center (UMMC)
Jackson, Mississippi, 39216
United States
University of Cincinatti
Cincinnati, Ohio, 45267
United States
Metrohealth Systems
Cleveland, Ohio, 44109
United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
University of Texas Health Science Center at Houston
Houston, Texas, 77030
United States
University of Washington
Seattle, Washington, 98104
United States

Collaborators and Investigators

Sponsor: Jason Sperry

  • Jason L Sperry, MD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-19
Study Completion Date2025-08-12

Study Record Updates

Study Start Date2022-04-19
Study Completion Date2025-08-12

Terms related to this study

Keywords Provided by Researchers

  • hemorrhage
  • trauma
  • whole blood

Additional Relevant MeSH Terms

  • Hemorrhagic Shock
  • Traumatic Injury