Massive Transfusion in Children-2: A Trial Examining Life Threatening Hemorrhage in Children (MATIC-2)
Hemorrhagic Shock, Trauma Injury
About this trial
This is an interventional treatment trial for Hemorrhagic Shock focused on measuring Children, Pediatrics, Transfusion
Eligibility Criteria
Inclusion Criteria: Children, defined as less than 18 years of age with traumatic injury 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: Hypotension for age (< 5% tile) Tachycardia for age (>95th % tile) Traumatic injury with exam findings consistent with severe bleeding (e.g., penetrating injury, hemothorax, distended abdomen with bruising, amputation of limb). Exclusion Criteria: Unknown time of injury Greater than 3 hours since time of injury History of seizure after the injury event Known allergy or hypersensitivity reaction to TXA Comatose (Glasgow Coma Score of 3) with fixed and dilated pupils suggesting nonsurvivable brain injury 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 obviously pregnant on clinical examination Known prisoners as defined in protocol Known ward of the state Isolated hanging, drowning or burns Previous enrollment in MATIC-2 Prior study opt-out with bracelet
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Other
Other
Other
Other
Group 1 (LTOWB+TXA)
Group 2 (LTOWB+Placebo)
Group 3 (TXA+CT)
Group 4 (CT+Placebo)
Concurrent administration of LTOWB and TXA.
Concurrent administration of LTOWB and Placebo
Concurrent administration of TXA and CT
Concurrent administration of CT and Placebo