search
Back to results

Whole Blood in Trauma Patients With Hemorrhagic Shock (WEBSTER)

Primary Purpose

Trauma, Trauma Injury, Trauma, Multiple

Status
Recruiting
Phase
Phase 3
Locations
Colombia
Study Type
Interventional
Intervention
Transfusion of blood products
Sponsored by
Fundacion Clinica Valle del Lili
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trauma focused on measuring whole blood, Blood Transfusion, Blood Component Transfusion, Hemorrhage, Advanced Trauma Life Support Care, Hemostatic resuscitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fundacion Clinica Valle del LiliRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Whole Blood

Blood Components Therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Multiple organ dysfunction incidence
Multiple organ dysfunction is a score ≥ 3 in two or more systems evaluated by SOFA score.
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.
Intensive care unit-free days
ICU-free days
Hospital length stay-free days
Hospital length stay-free days
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
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.
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

Full Information

First Posted
November 16, 2022
Last Updated
January 17, 2023
Sponsor
Fundacion Clinica Valle del Lili
Collaborators
University of Pittsburgh, Hospital Universitario del Valle Evaristo Garcia
search

1. Study Identification

Unique Protocol Identification Number
NCT05634109
Brief Title
Whole Blood in Trauma Patients With Hemorrhagic Shock
Acronym
WEBSTER
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 14, 2023 (Actual)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacion Clinica Valle del Lili
Collaborators
University of Pittsburgh, Hospital Universitario del Valle Evaristo Garcia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma, Trauma Injury, Trauma, Multiple
Keywords
whole blood, Blood Transfusion, Blood Component Transfusion, Hemorrhage, Advanced Trauma Life Support Care, Hemostatic resuscitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Single center, Controlled, Randomized, and Open label therapeutic trial.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Whole Blood
Arm Type
Experimental
Arm Description
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.
Arm Title
Blood Components Therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Transfusion of blood products
Intervention Description
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.
Primary Outcome Measure Information:
Title
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).
Description
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
Secondary Outcome Measure Information:
Title
24-hour mortality
Description
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.
Title
In-hospital mortality
Description
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
Title
Multiple organ dysfunction incidence
Description
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
Title
Evolution of Coagulopathy
Description
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
Title
Intensive care unit-free days
Description
ICU-free days
Time Frame
28-days post-ED admission
Title
Hospital length stay-free days
Description
Hospital length stay-free days
Time Frame
28-days post-ED admission
Title
Blood transfusion requirements during the first 24 hours
Description
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
Title
Proportion of participants with transfusional adverse reactions
Description
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
Title
Proportion of participants with adverse reactions
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alberto F Garcia, MD MSc
Phone
+576023319090
Ext
4299
Email
alberto.garcia@fvl.org.co
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alberto F Garcia, MD MSc
Organizational Affiliation
Fundacion Clinica Valle del Lili
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carlos A Ordoñez, MD
Organizational Affiliation
Fundacion Clinica Valle del Lili
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fundacion Clinica Valle del Lili
City
Cali
State/Province
Valle Del Cauca
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sergio I Prada, MPA PhD
Phone
+57 (2) 3319090
Ext
4022
Email
sergio.prada@fvl.org.co
First Name & Middle Initial & Last Name & Degree
Alberto F Garcia, MD MSc
First Name & Middle Initial & Last Name & Degree
Carlos A Ordoñez, MD
First Name & Middle Initial & Last Name & Degree
Carmenza Macia, MD
First Name & Middle Initial & Last Name & Degree
Gustavo Ospina, MD PhD
First Name & Middle Initial & Last Name & Degree
Yaset Caicedo, MD
First Name & Middle Initial & Last Name & Degree
Andres Gempeler, MD MSc
First Name & Middle Initial & Last Name & Degree
Liliana Vallecilla, MD

12. IPD Sharing Statement

Learn more about this trial

Whole Blood in Trauma Patients With Hemorrhagic Shock

We'll reach out to this number within 24 hrs