Massive Transfusion in Children-2: A Trial Examining Life Threatening Hemorrhage in Children
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
AgeUp to 17
SponsorPhilip Spinella
About this trial
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.
Eligibility criteria
Qualifiers
Children, defined as less than estimated18 years of age with traumatic injury
MTP activation for confirmed or suspected active life-threatening traumatic bleeding
Hypotension for age (< 5% tile)
Tachycardia for age (>95th % tile)
Disqualifiers
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)
MTP activated but no blood products given
Patients who required an ED thoracotomy or received more than 5 consecutive minutes of cardiopulmonary resuscitation (prior to receiving randomized blood products)
Patients who are known or suspected to be pregnant on clinical examination
Trial design
Treatments tested in this trial
- Low Titer Group O Whole Blood (LTOWB)
- Placebo
- Tranexamic Acid (TXA)
- Component Therapy (CT)
Treatment groups
1,000 Participants
are divided into 4 treatment groupsSponsors and collaborators
Philip Spinella
Lead sponsor
University of Pittsburgh
Sponsor institution
Biomedical Advanced Research and Development Authority
Collaborator
Source ClinicalTrials.gov