RECRUITING

Massive Transfusion in Children-2: A Trial Examining Life Threatening Hemorrhage in Children

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 MATIC-2 is a multicenter clinical trial enrolling children who are less than 18 years of age with hemorrhagic shock potentially needing significant blood transfusion. The primary objective of the clinical trial is to determine the effectiveness of Low Titer Group O Whole Blood (LTOWB) compared to component therapy (CT), and Tranexamic Acid (TXA) compared to placebo in decreasing 24-hour all-cause mortality in children with traumatic life threatening hemorrhage.

Official Title

Massive Transfusion in Children: a Platform RCT of Whole Blood Compared to Component Therapy and Tranexamic Acid to Placebo in Life-threatening Traumatic Bleeding

Quick Facts

Study Start:2024-11-01
Study Completion:2028-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06070350

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:Not specified to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 1. Children, defined as less than estimated18 years of age with traumatic injury
  2. 2. MTP activation for confirmed or suspected active life-threatening traumatic bleeding
  3. 1. Hypotension for age (\< 5% tile)
  4. 2. Tachycardia for age (\>95th % tile)
  5. 3. Traumatic injury with exam findings consistent with severe bleeding (e.g., penetrating injury, hemothorax, distended abdomen with bruising, amputation of limb).
  1. 1. Patient with devastating traumatic brain injury not expected to survive due to magnitude of injury (example: Transhemispheric gunshot wound with signs of herniation, GCS score of 3 with fixed and dilated pupils)
  2. 2. MTP activated but no blood products given
  3. 3. Patients who required an ED thoracotomy or received more than 5 consecutive minutes of cardiopulmonary resuscitation (prior to receiving randomized blood products)
  4. 4. Patients who are known or suspected to be pregnant on clinical examination
  5. 5. Known prisoners as defined in protocol
  6. 6. Known ward of the state
  7. 7. Isolated hanging, drowning or burns
  8. 8. Previous enrollment in MATIC-2
  9. 9. Prior study opt-out with bracelet
  10. 1. Prehospital or pre-enrollment use of TXA
  11. 2. Greater than 3 hours since time of injury
  12. 3. History of seizure after the injury event
  13. 4. Known allergy or hypersensitivity reaction to TXA

Contacts and Locations

Study Contact

Jane Luce
CONTACT
412-383-7853
jane.luce@pitt.edu

Principal Investigator

Philip C Spinella, MD
PRINCIPAL_INVESTIGATOR
Univesrity of Pittsburgh

Study Locations (Sites)

University of Arizona
Tucson, Arizona, 84719
United States
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
United States
University of California Davis
Sacramento, California, 95817
United States
Children's National Hospital
Washington, District of Columbia, 20010
United States
Emory University-Arthur M. Blank Hospital
Atlanta, Georgia, 30329
United States
Emory University-Scottish Rite Hospital
Atlanta, Georgia, 30342
United States
Tulane School of Medicine
New Orleans, Louisiana, 70118
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216
United States
Washington University of St. Louis
Saint Louis, Missouri, 63110
United States
University of New Mexico
Albuquerque, New Mexico, 87131
United States
Wake Forest University Health Sciences
Wake Forest, North Carolina, 27157
United States
Nationwide Children's Hospital
Columbus, Ohio, 43205
United States
Oregon Health and Science University
Portland, Oregon, 97239
United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
United States
LeBonheur Children's Hospital
Memphis, Tennessee, 38103
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
The University of Texas Southwestern Medical Center
Dallas, Texas, 75390
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
Children's Memorial Hermann Hospital
Houston, Texas, 77030
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
United States
Primary Children's Hospital
Salt Lake City, Utah, 84112
United States
University of Washington Harborview
Seattle, Washington, 98195
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Philip Spinella

  • Philip C Spinella, MD, PRINCIPAL_INVESTIGATOR, Univesrity 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 Date2024-11-01
Study Completion Date2028-10-01

Study Record Updates

Study Start Date2024-11-01
Study Completion Date2028-10-01

Terms related to this study

Keywords Provided by Researchers

  • Children
  • Pediatrics
  • Transfusion

Additional Relevant MeSH Terms

  • Hemorrhagic Shock
  • Trauma Injury