RECRUITING

Trauma Resuscitation With Low-Titer Group O Whole Blood or Products

Conditions

Wounds and Injuries Shock, Hemorrhagic Massive Transfusion Trauma Shock Hemorrhage Plasma Platelets Red Blood Cells Low-Titer Group O Whole Blood Blood components

Quick Navigation

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

The goal of this clinical trial is to compare the effectiveness of unseparated whole blood (referred to as Low-Titer Group O Whole Blood) and the separate components of whole blood (including red cells, plasma, platelets, and cryoprecipitate) in critically injured patients who require large-volume blood transfusions.

Official Title

Trauma Resuscitation With Low-Titer Group O Whole Blood or Products

Quick Facts

Study Start:2023-07-27

Study Completion:2027-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05638581

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:15 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Adult trauma patient (estimated age \> 15 or weight \> 50 kg, if age unknown) 2. Patient taken to trauma center directly from scene 3. Commencement of blood transfusion (PRBC, plasma or LTOWB), in pre-hospital or in-hospital setting 4. Activation of site-specific Massive Hemorrhage Protocol or Massive Transfusion Protocol 5. Traumatic injury with at least one of the following: 1. Confirmed or suspected acute major bleeding 2. Assessment of Blood Consumption (ABC) Score ≥2	1. Patients who have received, prehospital or in-hospital more than two units of LTOWB; the equivalent in components (two units of packed red blood cells and two units of plasma); or a combination of the two (more than one unit of LTOWB, one unit of packed cells, and one unit of plasma). Most trauma centers hold two units of either packed red blood cells (with two units of plasma) or two units of LTOWB in the emergency department. This stock is used to initiate transfusion, while the massive hemorrhage protocol is activated from the blood bank. 2. Patients transferred from another hospital 3. Children \<15 years (in most communities, patients aged 15-18 years are treated at adult trauma centers, and patients in this age group frequently suffer life-threatening injuries, and will therefore be included) 4. Known prisoners, defined as individuals involuntarily confined or detained in a penal institution (including juvenile detention, involuntary psychiatric commitment, or court-ordered residential substance abuse treatment) 5. Moribund patients expected to die within 1 hour 6. Patients who required an ED thoracotomy or received more than 5 consecutive minutes of cardiopulmonary resuscitation (prior to receiving randomized blood products) 7. Patients with known "do not resuscitate" orders prior to randomization 8. Patients who refuse the administration of blood products 9. Individuals with a research "opt out" bracelet. 10. Greater than 20% total body surface area (TBSA) burns 11. Suspected inhalation injury victims 12. Patients who are obviously pregnant on clinical examination or known to be pregnant as provided by the subject or legally authorized representative

Inclusion Criteria

Exclusion Criteria

1. Adult trauma patient (estimated age \> 15 or weight \> 50 kg, if age unknown)
2. Patient taken to trauma center directly from scene
3. Commencement of blood transfusion (PRBC, plasma or LTOWB), in pre-hospital or in-hospital setting
4. Activation of site-specific Massive Hemorrhage Protocol or Massive Transfusion Protocol
5. Traumatic injury with at least one of the following:
1. Confirmed or suspected acute major bleeding
2. Assessment of Blood Consumption (ABC) Score ≥2

1. Patients who have received, prehospital or in-hospital more than two units of LTOWB; the equivalent in components (two units of packed red blood cells and two units of plasma); or a combination of the two (more than one unit of LTOWB, one unit of packed cells, and one unit of plasma). Most trauma centers hold two units of either packed red blood cells (with two units of plasma) or two units of LTOWB in the emergency department. This stock is used to initiate transfusion, while the massive hemorrhage protocol is activated from the blood bank.
2. Patients transferred from another hospital
3. Children \<15 years (in most communities, patients aged 15-18 years are treated at adult trauma centers, and patients in this age group frequently suffer life-threatening injuries, and will therefore be included)
4. Known prisoners, defined as individuals involuntarily confined or detained in a penal institution (including juvenile detention, involuntary psychiatric commitment, or court-ordered residential substance abuse treatment)
5. Moribund patients expected to die within 1 hour
6. Patients who required an ED thoracotomy or received more than 5 consecutive minutes of cardiopulmonary resuscitation (prior to receiving randomized blood products)
7. Patients with known "do not resuscitate" orders prior to randomization
8. Patients who refuse the administration of blood products
9. Individuals with a research "opt out" bracelet.
10. Greater than 20% total body surface area (TBSA) burns
11. Suspected inhalation injury victims
12. Patients who are obviously pregnant on clinical examination or known to be pregnant as provided by the subject or legally authorized representative

Contacts and Locations

Study Contact

Shannon Stephens, EMTP, CCEMTP

CONTACT

205-934-5890

swstephens@uabmc.edu

Kiran Mansoor, MBBS

CONTACT

713-500-9643

Kiran.Mansoor@uth.tmc.edu

Principal Investigator

Jan Jansen, MBBS, PhD

PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Study Locations (Sites)

University of Alabama at Birmingham, UAB Hospital

Birmingham, Alabama, 35294

United States

Los Angeles County + University of Southern California (LAC + USC) Medical Center

Los Angeles, California, 90033

United States

University Medical Center New Orleans LCMC Health

New Orleans, Louisiana, 70112

United States

University of Maryland Medical Center

Baltimore, Maryland, 21201

United States

Washington University School of Medicine

Saint Louis, Missouri, 63110

United States

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157

United States

University of Cincinnati Medical Center

Cincinnati, Ohio, 45267

United States

Oregon Health and Sciences University Hospital

Portland, Oregon, 97239

United States

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104

United States

University of Texas Health Science Center Houston

Houston, Texas, 77030

United States

University of Texas Health San Antonio and University Health System

San Antonio, Texas, 78229

United States

Harborview Medical Center

Seattle, Washington, 98104

United States

Froedtert Hospital

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

Jan Jansen, MBBS, PhD, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

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 Date2023-07-27

Study Completion Date2027-06-30

Study Record Updates

Study Start Date2023-07-27

Study Completion Date2027-06-30

Terms related to this study

Keywords Provided by Researchers

Massive Transfusion
Trauma
Shock
Hemorrhage
Plasma
Platelets
Red Blood Cells
Low-Titer Group O Whole Blood
Blood components

Additional Relevant MeSH Terms

Wounds and Injuries
Shock, Hemorrhagic