TraumaPhase 3WEBSTERNCT05634109
Whole Blood in Trauma Patients With Hemorrhagic Shock
A Phase 3 study testing Transfusion of blood products in people with Trauma and Trauma Injury, run by Fundacion Clinica Valle del Lili at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma, Trauma Injury, Trauma, Multiple
- What is being tested?
- Transfusion of blood products
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteColombia
- Study dates
- 14 Jan 2023to Mar 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Colombia1 site, 1 recruiting
- Recruiting
Fundacion Clinica Valle del Lili
Cali, Valle del Cauca Department
Sergio I Prada, MPA PhD, +57 (2) 3319090 ext. 4022, sergio.prada@fvl.org.co
Alberto F Garcia, MD MSc
About this study
Official title: Whole Blood vs. Blood Components Therapy in the Hemostatic Resuscitation of Severe Trauma Patients: An Open-label, Randomized, Controlled Clinical Trial
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.
Read the 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)
- Conditions
- Trauma, Trauma Injury, Trauma, Multiple
- Being tested
- Transfusion of blood products
- Keywords
- whole blood, Blood Transfusion, Blood Component Transfusion, Hemorrhage, Advanced Trauma Life Support Care, Hemostatic resuscitation
- Medical subject headings
- Wounds and Injuries, Accidental Injuries, Multiple Trauma, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transfusion of blood productsBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Whole Blood | Experimental | 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. Receives: Biological: Transfusion of blood products |
| Blood Components Therapy | Active comparator | 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. Receives: Biological: Transfusion of blood products |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days post ED admission
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Admission - 3 hours - 6 hours - 24 hours post-ED admission
Intensive care unit-free days
ICU-free days
Measured: 28-days post-ED admission
Hospital length stay-free days
Hospital length stay-free days
Measured: 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
Measured: 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.
Measured: 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
Measured: 28-days post-ED admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2022
- Study start14 Jan 2023
- Primary completionDec 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single center, Controlled, Randomized, and Open label therapeutic trial.
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Clinica Valle del Lili
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh, Hospital Universitario del Valle Evaristo Garcia
- Responsible party
- Sponsor
- Investigators
- Alberto F Garcia, MD MSc, Principal investigator, Fundacion Clinica Valle del LiliCarlos A Ordoñez, MD, Principal investigator, Fundacion Clinica Valle del Lili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05634109
- Sponsor's protocol ID
- 1938
- Acronym
- WEBSTER
- Status last verified
- Feb 2025
- First submitted
- 16 Nov 2022
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Garcia AF, Caicedo Y, Gempeler A, Vallecilla L, Macia C, Orlas C, Fernandez MI, Lancheros-Ramirez P, Quintero M, Hernandez E, Vargas S, Cardenas-Perez L, Ariza F, Zarama V, Carvajal S, Billefals E, Sanchez A, Badiel M, Rosso F, Granados M, Albornoz LA, Puyana JC, Ospina-Tascon G, Ordonez CA. Transfusion of modified whole blood versus blood components therapy in patients with severe trauma: Randomized controlled trial protocol (WEBSTER trial). Injury. 2025 May;56(5):112173. doi: 10.1016/j.injury.2025.112173. Epub 2025 Jan 23.
PubMed 40087111
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole Blood vs. Blood Components Therapy in the Hemostatic Resuscitation of Severe Trauma Patients: An Open-label, Randomized, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05634109
- Acronym / sponsor ID
- WEBSTER / 1938
- Conditions
- Trauma, Trauma Injury, Trauma, Multiple
- Keywords
- whole blood, Blood Transfusion, Blood Component Transfusion, Hemorrhage, Advanced Trauma Life Support Care, Hemostatic resuscitation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Fundacion Clinica Valle del LiliUniversity, hospital or other
- Collaborators
- University of Pittsburgh, Hospital Universitario del Valle Evaristo Garcia
- Study start
- 14 Jan 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 1 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single center, Controlled, Randomized, and Open label therapeutic trial.
| Arm | Type | Receives |
|---|---|---|
| Whole Blood | Experimental | Biological: Transfusion of blood productsLeukoreduced 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. |
| Blood Components Therapy | Active comparator | Biological: Transfusion of blood products1:1:1 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transfusion of blood productsThe 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. | Biological | Blood Components Therapy, Whole Blood |
Primary outcome
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).
Time frame: 28 days post ED admission
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.
9 secondary outcomes
24-hour mortality
Time frame: First 24 hours post ED admission.
In-hospital mortality
Time frame: 28 days post ED admission
Multiple organ dysfunction incidence
Time frame: 1-day / 3-day / 5-day / 7-day post-ED admission
Evolution of Coagulopathy
Time frame: Admission - 3 hours - 6 hours - 24 hours post-ED admission
Intensive care unit-free days
Time frame: 28-days post-ED admission
Hospital length stay-free days
Time frame: 28-days post-ED admission
Blood transfusion requirements during the first 24 hours
Time frame: Time frame 3 hours / 6 hours / 12 hours / 24 hours
Proportion of participants with transfusional adverse reactions
Time frame: 28-days post-ED admission
Proportion of participants with adverse reactions
Time frame: 28-days post-ED admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Derived from this study: PubMed 40087111Garcia AF, Caicedo Y, Gempeler A, Vallecilla L, Macia C, Orlas C, Fernandez MI, Lancheros-Ramirez P, Quintero M, Hernandez E, Vargas S, Cardenas-Perez L, Ariza F, Zarama V, Carvajal S, Billefals E, Sanchez A, Badiel M, Rosso F, Granados M, Albornoz LA, Puyana JC, Ospina-Tascon G, Ordonez CA. Transfusion of modified whole blood versus blood components therapy in patients with severe trauma: Randomized controlled trial protocol (WEBSTER trial). Injury. 2025 May;56(5):112173. doi: 10.1016/j.injury.2025.112173. Epub 2025 Jan 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alberto F Garcia, MD MSc principal investigator
Fundacion Clinica Valle del Lili
Carlos A Ordoñez, MD principal investigator
Fundacion Clinica Valle del Lili
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Transfusion of blood products in people with Trauma and Trauma Injury, run by Fundacion Clinica Valle del Lili at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alberto F Garcia, MD MSc (+576023319090 ext. 4299, alberto.garcia@fvl.org.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). (time frame: 28 days post ED admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05634109, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.