Trauma Resuscitation With Low-Titer Group O Whole Blood or Products

Обзор

The goal of this clinical trial is to compare the effectiveness of unseparated whole blood (referred to as Low-Titer Group O Whole Blood) and the separate components of whole blood (including red cells, plasma, platelets, and cryoprecipitate) in critically injured patients who require large-volume blood transfusions.

Подробное описание

Trauma is one of the leading causes of death in the United States, and disproportionately affects the young, killing those who might otherwise have lived long and productive lives. Injuries account for more years of potential life lost before age 75 than any other cause. Hemorrhage remains the most common cause of preventable death after injury, and blood transfusion is an essential part of treatment. Modern blood banking practices separate donated whole blood into components. The current standard of care in trauma transfusion is the balanced administration of equal numbers of units of blood components (packed red blood cells, plasma, and platelets), effectively attempting to reconstitute whole blood. A renewed approach to blood transfusion therapy in trauma is to use whole blood from the outset, which has not been separated. Compared with component therapy, whole blood offers several potential advantages, but there are only a small number of, mostly observational, studies comparing whole blood and component therapy, and they are very heterogeneous.

The TROOP trial will include injured adults with hemorrhagic shock anticipated to require massive blood transfusions, who will be randomized to receive either whole blood (LTOWB) or blood components. This will allow a direct comparison to see if one type of transfusion is more strongly associated with improved clinical outcomes over the other.

The knowledge gained from this clinical trial will transform the way in which massively bleeding trauma patients are transfused. The trial is exceedingly well positioned to improve mortality from trauma and reduce the number of preventable deaths resulting from hemorrhagic shock.

Вмешательства

• Биопрепарат LTOWB
  Participants will receive Low Titer O Whole Blood administered intravenously or intraosseously.
• Биопрепарат Components
  Participants will receive separated blood components (i.e., units of red cells, plasma, platelets, and cryoprecipitate) co-administered intravenously or intraosseously.

Первичные конечные точки

• 6-hour Mortality [Срок оценки: First 6 hours after randomization]

Вторичные конечные точки (12)

• 24-hour Mortality [Срок оценки: First 24 hours after randomization]
• Hospital/30-day Mortality [Срок оценки: From randomization to hospital discharge or 30-days post randomization (whichever the earlier)]
• Incidence of Pre-specified Complications [Срок оценки: From randomization to hospital discharge or 30-days post randomization (whichever the earlier)]
• Adjudicated Primary Cause of Death [Срок оценки: 30-days post randomization]
• Length of Stay (Hospital and Intensive Care Unit) [Срок оценки: From randomization to hospital discharge or 30-days post randomization (whichever the earlier)]
• Hospital-, Ventilator- and Intensive Care Unit-free days [Срок оценки: 30-days post randomization]
• Incidence of major surgical procedures [Срок оценки: From randomization to hospital discharge or 30-days post randomization (whichever the earlier)]
• Time to hemostasis in those undergoing procedures with a hemostatic component [Срок оценки: From randomization to hospital discharge or 30-days post randomization (whichever the earlier)]
• Number and type of blood products used until hemostasis is achieved and from hemostasis to 24 hours after randomization [Срок оценки: First 24 hours after randomization]
• Discharge destination [Срок оценки: At hospital discharge or 30-days post randomization (whichever the earlier)]
• Functional status [Срок оценки: From randomization to hospital discharge or 30-days post randomization (whichever the earlier)]
• Patient's quality of life [Срок оценки: From randomization to hospital discharge or 30-days post randomization (whichever the earlier)]

Критерии участия

Критерии включения

• Adult trauma patient (estimated age > 15 or weight > 50 kg, if age unknown)
• Patient taken to trauma center directly from scene
• Commencement of blood transfusion (PRBC, plasma or LTOWB), in pre-hospital or in-hospital setting
• Activation of site-specific Massive Hemorrhage Protocol or Massive Transfusion Protocol
• Traumatic injury with at least one of the following:

• Confirmed or suspected acute major bleeding
• Assessment of Blood Consumption (ABC) Score ≥2

Критерии исключения

• Patients who have received, prehospital or in-hospital more than two units of LTOWB; the equivalent in components (two units of packed red blood cells and two units of plasma); or a combination of the two (more than one unit of LTOWB, one unit of packed cells, and one unit of plasma). Most trauma centers hold two units of either packed red blood cells (with two units of plasma) or two units of LTOWB in the emergency department. This stock is used to initiate transfusion, while the massive hemorrhage protocol is activated from the blood bank.
• Patients transferred from another hospital
• Children <15 years (in most communities, patients aged 15-18 years are treated at adult trauma centers, and patients in this age group frequently suffer life-threatening injuries, and will therefore be included)
• Known prisoners, defined as individuals involuntarily confined or detained in a penal institution (including juvenile detention, involuntary psychiatric commitment, or court-ordered residential substance abuse treatment)
• Moribund patients expected to die within 1 hour
• Patients who required an ED thoracotomy or received more than 5 consecutive minutes of cardiopulmonary resuscitation (prior to receiving randomized blood products)
• Patients with known "do not resuscitate" orders prior to randomization
• Patients who refuse the administration of blood products
• Individuals with a research "opt out" bracelet.
• Greater than 20% total body surface area (TBSA) burns
• Suspected inhalation injury victims
• Patients who are obviously pregnant on clinical examination or known to be pregnant as provided by the subject or legally authorized representative

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 13 центров

• University of Alabama at Birmingham, UAB Hospital — Birmingham
• Los Angeles County + University of Southern California (LAC + USC) Medical Center — Los Angeles
• University Medical Center New Orleans LCMC Health — New Orleans
• University of Maryland Medical Center — Baltimore
• Washington University School of Medicine — St Louis
• Atrium Health Wake Forest Baptist — Winston-Salem
• University of Cincinnati Medical Center — Cincinnati
• Oregon Health and Sciences University Hospital — Portland
• … и ещё 5 центров

Публикации

• Jansen JO, Pedroza C, Novelo LL, Hao T, DeWildt GR, Coton CF, Mansoor K, Stephens SW, Marques MB, Stubbs JR, Richter JR, Wang HE, Holcomb JB, DeSantis SM. Trauma resuscitation with Low-Titer Group O Whole Blood Or Products: study protocol for a randomized clinical trial (the TROOP trial). Trials. 2025 Aug 2;26(1):266. doi: 10.1186/s13063-025-08971-y. PMID 40753420
• Meizoso JP, Cotton BA, Lawless RA, Kodadek LM, Lynde JM, Russell N, Gaspich J, Maung A, Anderson C, Reynolds JM, Haines KL, Kasotakis G, Freeman JJ. Whole blood resuscitation for injured patients requiring transfusion: A systematic review, meta-analysis, and practice management guideline from the Eastern Association for the Surgery of Trauma. J Trauma Acute Care Surg. 2024 Sep 1;97(3):460-470. doi PMID 38531812

Идентификаторы

NCT: NCT05638581 · 1UG3HL157401-01A1 · 1UG3HL157401-01A1 · 1U24HL157310-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗