NCT06070350 Massive Transfusion in Children-2: A Trial Examining Life Threatening Hemorrhage in Children
| NCT ID | NCT06070350 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Philip Spinella |
| Condition | Hemorrhagic Shock |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2024-11-01 |
| Primary Completion | 2028-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 1,000 participants in total. It began in 2024-11-01 with a primary completion date of 2028-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
General Inclusion Criteria: 1. Children, defined as less than estimated18 years of age with traumatic injury 2. MTP activation for confirmed or suspected active life-threatening traumatic bleeding AND Confirmed or suspected active life-threatening traumatic bleeding with at least 2 of 3 of the following criteria: 1. Hypotension for age (\< 5% tile) 2. Tachycardia for age (\>95th % tile) 3. Traumatic injury with exam findings consistent with severe bleeding (e.g., penetrating injury, hemothorax, distended abdomen with bruising, amputation of limb). General Exclusion Criteria: 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. MTP activated but no blood products given 3. Patients who required an ED thoracotomy or received more than 5 consecutive minutes of cardiopulmonary resuscitation (prior to receiving randomized blood products) 4. Patients who are known or suspected to be pregnant on clinical examination 5. Known prisoners as defined in protocol 6. Known ward of the state 7. Isolated hanging, drowning or burns 8. Previous enrollment in MATIC-2 9. Prior study opt-out with bracelet Exclusion Criteria for the TXA/Placebo Domain 1. Prehospital or pre-enrollment use of TXA 2. Greater than 3 hours since time of injury 3. History of seizure after the injury event 4. Known allergy or hypersensitivity reaction to TXA
Contact & Investigator
Philip C Spinella, MD
PRINCIPAL INVESTIGATOR
Univesrity of Pittsburgh
Frequently Asked Questions
Who can join the NCT06070350 clinical trial?
This trial is open to participants of all sexes, up to 17 Years, studying Hemorrhagic Shock. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06070350 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 1,000 participants.
Is NCT06070350 currently recruiting?
Yes, NCT06070350 is actively recruiting participants. Contact the research team at tdb33@pitt.edu for enrollment information.
Where is the NCT06070350 trial being conducted?
This trial is being conducted at Tucson, United States, Little Rock, United States, Sacramento, United States, Washington D.C., United States and 11 additional locations.
Who is sponsoring the NCT06070350 clinical trial?
NCT06070350 is sponsored by Philip Spinella. The principal investigator is Philip C Spinella, MD at Univesrity of Pittsburgh. The trial plans to enroll 1,000 participants.