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

ConditionsHemorrhagic ShockTrauma Injury
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

This trial does not accept healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

  • Low Titer Group O Whole Blood (LTOWB)

    Biological/Vaccine

    LTOWB is whole blood from group O donors with low titer (\<200) anti-A and anti-B antibodies. Up to 8 units of LTOWB will be allowed unless local clinical practice allows for a higher maximum dose.

  • Placebo

    Drug

    Placebo will be provided to the research pharmacy at each of the clinical sites

  • Tranexamic Acid (TXA)

    Drug

    TXA is a synthetic lysine analog that competitively inhibit activation of plasminogen, thereby decreasing the conversion of plasminogen to plasmin, preventing degradation of fibrin's matrix structure. Dose is 25mg/kg IV or IO (maximum 2 grams).

  • Component Therapy (CT)

    Biological/Vaccine

    Component Therapy (CT) will be RBCs, plasma and platelet units in a 1:1:1 unit ratio. This will be given with Placebo

Treatment groups

1,000 Participants
are divided into 4 treatment groups
Group A: Group 1 (LTOWB+TXA)Other 2 interventions
Group B: Group 2 (LTOWB+Placebo)Other 2 interventions
Group C: Group 3 (CT+TXA)Other 2 interventions
Group D: Group 4 (CT+Placebo)Other 2 interventions

Trial outcomes

Primary outcomes

1

24 hours all cause mortality

Time frame
24 hours

Secondary outcomes

1

6-hour, 72-hour and 28-day survival

Cumulative survival over time through 28 days post-enrollment: includes 6-hour, 72-hour and 28-day survival.

Time frame
6, 72 hours and 28 days
2

24 hours total blood product transfusion volumes

Total blood product transfusion in 24 hours after enrollment.

Time frame
24 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Philip Spinella

Lead sponsor

University of Pittsburgh

Sponsor institution

Biomedical Advanced Research and Development Authority

Collaborator

Source ClinicalTrials.gov
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