Low Titer Group O Whole Blood for Severe Bleeding in Kids
Massive Transfusion in Children-2: A Trial Examining Life Threatening Hemorrhage in Children
Recruiting
Phase 3Interventional Study
Hemorrhagic ShockTrauma 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.
Ready to participate?
Review the details below, then apply to join this clinical 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
Who this trial is looking for
This trial is looking for children under 18 who are experiencing life-threatening bleeding from a traumatic injury. Participants will receive either Low Titer Group O Whole Blood or standard treatment to see which is more effective in improving survival.
Are You a Good Fit for This Trial?
You may be able to join if
I am under 18 years old
I have a traumatic injury
I have life-threatening bleeding
I have low blood pressure for my age
I have a fast heart rate for my age
I have signs of severe bleeding, like a deep wound or bruising
You may not be able to join if
I have a serious brain injury that isn't survivable
I was activated for massive transfusion but didn't receive any blood
I needed chest surgery or CPR for more than 5 minutes
I am pregnant
I am a prisoner
I am a ward of the state
I have only been injured by hanging, drowning, or burns
I have previously participated in this trial
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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.
Trial Locations
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City
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Status
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…
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
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