A Phase 3 interventional study of Transfusion of blood products in Trauma, Trauma Injury and Trauma, Multiple, sponsored by Fundacion Clinica Valle del Lili. Recruiting at 1 site in Colombia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-27.
Sponsored by Fundacion Clinica Valle del Lili · Phase 3, Interventional, and Treatment
This study aims to evaluate among trauma patients with hemorrhagic shock the clinical impact of hemostatic resuscitation between whole blood vs. blood components therapy in the following outcomes in a hierarchical analysis: mortality at 28 days and evolution of organ dysfunction.
Background: Hemostatic resuscitation is a mainstay in the management of trauma patients. Factors such as blood loss and tissue injury contribute to coagulation and hemodynamic status imbalances. Hemorrhage remains a leading cause of death in trauma patients, despite advances in strategies such as damage control surgery, massive transfusion protocol, and intensive care.
Conventional therapy for hemostatic resuscitation is a blood transfusion seeking a 1:1:1 ratio of red blood cells, plasma, and platelets. However, this ratio has disadvantages in clinical practice, especially in low-resource settings. Whole blood transfusion can contribute to maintaining a physiological rate of cells, clotting factors, and hemostatic properties. Advances in the whole blood elucidated a new opportunity for its implementation in civilian trauma centers. However, the effect of initial resuscitation with whole blood in trauma patients is unclear. This study aims to determine the effect of hemostatic resuscitation using whole blood on mortality and evolution of organ dysfunction in severe trauma patients compared to blood components therapy. This clinical trial attempts to resolve the debate and uncertainty of using whole blood vs. blood components.
Study Design: An open-label, randomized, prospective, single-center and controlled trial will be performed. This study will be included prospectively randomized severe trauma patients who require a blood transfusion. Randomization can assign participants to the experimental arm, transfusing them with 3 units of whole blood. If the participant continues requiring transfusions, the second intervention of 3 units of whole blood can be administered. On the contrary, the randomization can assign to the control arm, where the participant will receive 3 red blood cell units, 3 fresh frozen plasma units, and half of a platelets apheresis, equivalent to 3 platelets units. If required, a second intervention with the same ratio can be transfused to participants.
The primary outcome is a hierarchical composite outcome based on mortality at 28 days and the evolution of organ dysfunction. Organ dysfunction will be measured as the difference in the score between the fifth and first days of the SOFA (Sequential Organ Failure Assessment). Secondary outcomes are mortality, coagulopathy profile, intensive care unit free days, length of hospital stay free days, and volumes of transfusion requirements. Safety outcomes are complications related to transfusion (anaphylaxis, acute hemolytic reaction, acute lung injury) and complications related to trauma patients (acute distress respiratory syndrome, pulmonary embolism, deep vein thrombosis, acute kidney injury with or without dialysis, stroke, myocardial infarction, cardiac arrest, sepsis, abdominal complications, abdominal compartment syndrome)
5,085 studies on the registry are indexed under Wounds and Injuries; 849 are open to participants now.
This study's planned enrollment of 220 is above the median of 52 across 3,261 interventional studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →Fundacion Clinica Valle del Lili is the lead sponsor of 25 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
Leukoreduced whole blood with a platelet-sparing filter. Participants will be transfused with 3 whole blood units. If the participant requires, an additional transfusion pack composite by 3 whole blood units will be administered.
Biological: Transfusion of blood products
1:1:1 ratio of red blood cells unit, plasma unit, and platelets unit. Participants will be transfused with 3 red blood cell units, 3 fresh frozen plasma units, and 3 platelets units. A second intervention with the same ratio can be transfused to participants if they require it.
Biological: Transfusion of blood products
The intervention will be either a) administration of 6 units of whole blood or b) administration of blood component therapy in the proportion of 6:6:6 units of red blood cells, plasma, and platelets.
The primary outcome is a hierarchical outcome consisting of mortality at 28 days post-randomization and evolution of organ dysfunction (difference of Sequential Organ Failure Assessment (SOFA) score between day 1 and day 5 post-randomization).
The primary outcome is a hierarchical composite outcome that will be analyzed using the Win-Ratio test. The first level will be 28-day mortality. The "winner" will be the participant who survival; in case of a tie, the second level will be the difference in SOFA score between fifth and first day. The "winner" will be participant with the lowest difference.
Time frame: 28 days post ED admission
24-hour mortality
The occurrence of deaths in the first 24 hours post-ED admission and we will document and record the time of death in hours.
Time frame: First 24 hours post ED admission.
In-hospital mortality
The occurrence of deaths during the hospital stays post-ED admission, and we will document and record the time of death in days.
Time frame: 28 days post ED admission
Multiple organ dysfunction incidence
Multiple organ dysfunction is a score ≥ 3 in two or more systems evaluated by SOFA score.
Time frame: 1-day / 3-day / 5-day / 7-day post-ED admission
Evolution of Coagulopathy
We will evaluate the values of INR, fibrinogen, and MA-TEG during the admission and the first 24 hours post-ED admission.
Time frame: Admission - 3 hours - 6 hours - 24 hours post-ED admission
Intensive care unit-free days
ICU-free days
Time frame: 28-days post-ED admission
Hospital length stay-free days
Hospital length stay-free days
Time frame: 28-days post-ED admission
Blood transfusion requirements during the first 24 hours
The number of units of whole blood or blood components transfused. Comparisons will be according to the following references: * 1 Unit of Whole blood = 1 Unit of packed red blood cells. * 1 Unit of Whole Blood = 1 Unit of Plasma * 1 Unit of Whole Blood = 1 Unit of Platelets
Time frame: Time frame 3 hours / 6 hours / 12 hours / 24 hours
Proportion of participants with transfusional adverse reactions
We will document transfusional adverse reactions such as acute hemolytic reaction, anaphylaxis, non-hemolytic febrile transfusion reaction, allergy, and potassium and calcium electrolyte disorders.
Time frame: 28-days post-ED admission
Proportion of participants with adverse reactions
We will document adverse reactions such as acute lung injury, acute respiratory distress syndrome, pulmonary embolism, deep vein thrombosis, acute kidney injury with or without dialysis, stroke, myocardial infarction, cardiac arrest, sepsis, abdominal complications, and abdominal compartment syndrome
Time frame: 28-days post-ED admission
Started Jan 2023 (actual). Primary completion is estimated for Dec 2025, 35 months after the start.
Of 63 non-industry phase 3 interventional studies under Wounds and Injuries, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 62. This study's planned 35 months is below that.
Counting every sponsor, half of 76 studies reached it within 37 months; a quarter within 17 and three quarters within 60.
Wounds and Injuries covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
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Fundacion Clinica Valle del Lili