Clinical trial NCT05634109: Whole Blood in Trauma Patients With Hemorrhagic Shock
Official title: Whole Blood vs. Blood Components Therapy in the Hemostatic Resuscitation of Severe Trauma Patients: An Open-label, Randomized, Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Trauma
Trauma Injury
Trauma, Multiple
Keywords: whole blood
Blood Transfusion
Blood Component Transfusion
Hemorrhage
Advanced Trauma Life Support Care
Hemostatic resuscitation
Lead sponsor: Fundacion Clinica Valle del Lili
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh
name: Hospital Universitario del Valle Evaristo Garcia
First posted: 2022-12-01
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single center, Controlled, Randomized, and Open label therapeutic trial.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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)

Eligibility criteria: Inclusion Criteria:

* Adult patients (\> 18 years)
* Activating institutional trauma code for trauma patients with hemorrhagic shock.
* Candidate for massive transfusion (Patient with an Assessment Blood Consumption (ABC) Score ≥ 2 or at the discretion of the treating physician)
* Concurrent availability of whole blood or blood component therapy

Exclusion Criteria:

* More than 4 hours from trauma to hospital admission
* More than 2 hours from hospital admission to randomization
* Transfusion of more than one packed red blood cell unit prior to randomization.
* Patients who have undergone surgery (laparotomy, thoracotomy, or sternotomy) before hospital admission.
* In-extremis patients with devastating injuries (expected to die within 60 minutes).
* Blood group other than to O or A and positive Rh factor
* Severe traumatic brain injury in which neurosurgical intervention is futile (partial decapitation, massive intracranial hemorrhage, or transcranial gunshot wounds).
* Burns over 20% of the total body surface area.
* Suspected airway burn.
* Cardiopulmonary resuscitation (CPR) before arrival at the ED.
* CPR for more than 5 minutes before randomization.
* Do not resuscitate order.
* Incarcerated/prisoners.
* Known pregnancy in the ED.
* Patient or legal representative who refuse to participate in clinical research studies.

Primary outcomes:
measure: 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).
timeFrame: 28 days post ED admission
Secondary outcomes:
measure: 24-hour mortality
timeFrame: First 24 hours post ED admission.
measure: In-hospital mortality
timeFrame: 28 days post ED admission
measure: Multiple organ dysfunction incidence
timeFrame: 1-day / 3-day / 5-day / 7-day post-ED admission
measure: Evolution of Coagulopathy
timeFrame: Admission - 3 hours - 6 hours - 24 hours post-ED admission
measure: Intensive care unit-free days
timeFrame: 28-days post-ED admission
measure: Hospital length stay-free days
timeFrame: 28-days post-ED admission
measure: Blood transfusion requirements during the first 24 hours
timeFrame: Time frame 3 hours / 6 hours / 12 hours / 24 hours
measure: Proportion of participants with transfusional adverse reactions
timeFrame: 28-days post-ED admission
measure: Proportion of participants with adverse reactions
timeFrame: 28-days post-ED admission
Other outcomes:
Locations:
city: Cali
country: Colombia
facility: Fundacion Clinica Valle del Lili
state: Valle del Cauca
Study officials:
affiliation: Fundacion Clinica Valle del Lili
name: Alberto F Garcia, MD MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Fundacion Clinica Valle del Lili
name: Carlos A Ordoñez, MD
role: PRINCIPAL_INVESTIGATOR
References: