Massive Transfusion in Children-2: A Trial Examining Life Threatening Hemorrhage in Children
Recruiting
Phase 3
Interventional Study
Hemorrhagic Shock
Trauma Injury
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- Up to 17
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 1,000 (estimated)
- Sponsor
- Philip Spinella · Other
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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-c…
Trial Locations
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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 fo…
Contacts