TraumaNCT02926274
Transfusion Using Stored Whole Blood
An observational study of Trauma and Hemorrhage, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Massive hemorrhage is a major cause of potentially preventable death following trauma. A common consequence of hemorrhagic shock is uncontrollable bleeding from coagulopathy, leading to death from exsanguination. Even when bleeding is controlled, patients are at increased risk of complications and mortality. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Trauma, Hemorrhage, Coagulopathy
- How many people
- 330 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2017to 24 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All trauma patients presenting to Ronald Reagan UCLA Medical Center with systolic blood pressure <100 suspected due to hemorrhage are eligible. Adult males will receive whole blood when available. Adult female patients will receive component therapy.
Who may be able to join
- All adult trauma patients presenting to Ronald Reagan University of California Los Angeles (UCLA) Medical Center with systolic blood pressure <100 suspected due to hemorrhage are eligible. Adult males will receive whole blood when available. Adult female patients will receive component therapy.
Who cannot join
- Burn patients, patients with medical bracelets or other directives refusing blood transfusion if known during emergent resuscitation for traumatic injury, pediatric patients
Trial locations and contacts
1 site in 1 country.
United States1 site
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
About this study
Official title: Transfusion of Stored Whole Blood in a Civilian Trauma Center: A Prospective Evaluation of Feasibility and Outcomes
Massive hemorrhage is a major cause of potentially preventable death following trauma. A common consequence of hemorrhagic shock is uncontrollable bleeding from coagulopathy, leading to death from exsanguination. Even when bleeding is controlled, patients are at increased risk of complications and mortality. Reconstituted whole blood, or component therapy with packed red blood cells (PRBCs), plasma, and platelets was introduced by the military in recent conflicts in Iraq and Afghanistan with remarkable results and has been adopted by most civilian trauma centers. Despite improving coagulopathy, it is apparent that transfusion of blood components is not equivalent to whole blood transfusion. Transfusion of high plasma volumes may be associated with increased risk of allergic reaction, transfusion associated acute lung injury (TRALI), hypervolemic cardiac failure, and acute respiratory distress syndrome (ARDS). Military services have recently reintroduced fresh whole blood (WB) for standard resuscitation of massive hemorrhage, have found that WB offers a survival advantage over component therapy, and that risks of transfusion reactions are similar for WB and PRBCs. On the civilian side, whole blood is an FDA-licensed product that has been in use in pediatric open heart surgery and autologous blood donation but is no longer commonly available for other indications. However, the military results are renewing interest in whole blood for trauma resuscitation. The use of low-antibody titer whole blood leukoreduced with a platelet-sparing filter was recently approved by the University of California Los Angeles Blood and Blood Derivatives Committee and two other trauma centers for male trauma patients. This study will test the feasibility of providing stored WB for resuscitation of patients in hemorrhagic shock and determine the effects of WB on clinical outcomes as well as the effects on coagulation, fibrinolysis, and inflammation, compared to standard blood component therapy.
Read the detailed description
Most current massive transfusion protocols attempt to treat the early coagulopathic state induced by severe injury and hemorrhagic shock with transfusion of red blood cells, plasma, and platelets in a 1:1:1 ratio replicating whole blood. Civilian trauma centers have now begun to initiate resuscitation of adult male patients with stored whole blood as a standard of care, however.
The main hypothesis behind this change in practice is that transfusion of whole blood (WB) rather than attempted reconstitution from its banked components is safer, more efficient and effective treatment of hemorrhagic shock following injury and will result in less frequent development of clinical coagulopathy and subsequent mortality. Whole blood offers the advantages of more precisely approximating shed blood; decreased volume of additives per unit; and exposure to a decreased number of donors for a patient undergoing massive transfusion. It remains to be seen whether this will translate into differences in coagulopathy, inflammation, and mortality. The purpose of this study is to investigate the feasibility of developing a system to collect, store, and deliver whole blood for trauma resuscitations in a civilian trauma center.
The universal donor blood type for patients with unknown blood type is type O positive blood for males and O negative for females. Because O negative blood is rare the study will initiate the change in practice in adult male patients and later extend it to female patients if feasible. The study will determine the effects of WB transfusion in adult male patients compared to transfusion of PRBCS, plasma, and platelets in a 1:1:1 ratio in non adult male patients on markers of coagulation, fibrinolysis, and inflammation, as well as the development of complications and hospital mortality following severe injury.
Specific aims are to:
- Determine the appropriate shelf life of WB that has been leukoreduced with a platelet sparing filter by measuring changes in levels of coagulation factors and global clotting potential of banked units over time. To accomplish this the investigators will measure variables known to reflect potential and actual clotting capacity including platelet function and overall clotting ability by thromboelastography (TEG) and thrombin generation analysis in whole blood up to 35 days.
- Prospectively determine the effectiveness of trauma resuscitation using WB compared to component therapy and its effects on variables known to reflect potential and actual clotting capacity including markers of coagulation, fibrinolysis, inflammation, platelet function and global hemostatic potential post transfusion, as well as hospital outcomes including development of coagulopathy, infection, venous thromboembolism (VTE), multiple organ failure (MOF), total transfusion requirements, and mortality.
- Test the feasibility and implementation of a system to provide WB for resuscitation of trauma patients in hemorrhagic shock in civilian trauma centers. This will be accomplished by monitoring cost, storage needs, frequency of blood collection, number of donors, inventory, utilization and wastage of unused units.
- Conditions
- Trauma, Hemorrhage, Coagulopathy
- Keywords
- whole blood, trauma, transfusion, coagulopathy
- Medical subject headings
- Wounds and Injuries, Hemorrhage, Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Whole Blood | Adult male trauma patients presenting with systolic blood pressure <100 will receive up to 6 units of whole blood when available. | |
| Component therapy | Adult female patients presenting with systolic blood pressure <100, as well as adult male patients with systolic blood pressure <100 during periods when whole blood is not available, will receive component therapy (1:1:1 packed red blood cells: plasma:platelets) for transfusion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of blood products transfused during resuscitation
Volume of blood products transfused (whole blood, packed red blood cells, platelets, and plasma) within the first 24 hours of admission.
Measured: From admission to 24 hours after admission
Secondary outcomes (20)
mortality
Measured: Mortality at 30 days after injury
platelet mapping by thromboelastography
Platelet mapping determines the degree of inhibition of platelet function, measured on blood samples from patients being resuscitated during hemorrhagic shock. The primary outcome is the sample taken immediately following transfusion of 6 units of whole blood or packed red blood cells during initial resuscitation (almost always within one day of injury); or, if less than 6 units are transfused before hemostasis is achieved, immediately after transfusion of the last unit (within one day after injury).
Measured: within one day of injury, after 6 units of whole blood or packed red blood cell transfusion, or after hemostasis is achieved if less than 6 units are required
Thromboelastography reaction time
Determines the time to first evidence of clot formation, measured on blood samples from patients being resuscitated during hemorrhagic shock. The primary outcome is the sample taken immediately following transfusion of 6 units of whole blood or packed red blood cells during initial resuscitation (almost always within one day of injury); or, if less than 6 units are transfused before hemostasis is achieved, immediately after transfusion of the last unit (within one day after injury).
Measured: within one day of injury, after 6 units of whole blood or packed red blood cell transfusion, or after hemostasis is achieved if less than 6 units are required
Thromboelastography K value
Determines the time from first evidence of clot formation to the time the clot reaches a diameter of 20mm, thus representing the rate of clot formation. This will be measured on blood samples from patients being resuscitated during hemorrhagic shock. The primary outcome is the sample taken immediately following transfusion of 6 units of whole blood or packed red blood cells during initial resuscitation (almost always within one day of injury); or, if less than 6 units are transfused before hemostasis is achieved, immediately after transfusion of the last unit (within one day after injury).
Measured: within one day of injury, after 6 units of whole blood or packed red blood cell transfusion, or after hemostasis is achieved if less than 6 units are required
Thromboelastography maximum amplitude (MA)
Maximum amplitude is a measure of overall clot strength measured on blood samples from patients being resuscitated during hemorrhagic shock. The primary outcome is the sample taken immediately following transfusion of 6 units of whole blood or packed red blood cells during initial resuscitation (almost always within one day of injury); or, if less than 6 units are transfused before hemostasis is achieved, immediately after transfusion of the last unit (within one day after injury).
Measured: within one day of injury, after 6 units of whole blood or packed red blood cell transfusion, or after hemostasis is achieved if less than 6 units are required
total units of blood products transfused (includes whole blood, packed red blood cells, plasma, platelets, and cryoprecipitate).
Measured: 3 and 6 hours after admission, 24 hours after admission, and total for hospital stay within 30 days of injury
venous thromboembolism
Measured: any venous thromboembolism occurring during hospitalization within 30 days of injury.
infection (documentation of suspected or confirmed infection in the medical chart including urinary tract infection, pneumonia, wound infection, infectious colitis, and bacteremia).
Measured: during hospitalization within 30 days of injury.
Development of clinical coagulopathy
Documentation of diffuse clinical bleeding or documented clinical coagulopathy based on laboratory evidence by the primary team
Measured: Within 24 hours of injury, and during hospitalization within 30 days
Development of Acute Respiratory Distress Syndrome
Measured: During hospitalization within 30 days
Development of acute kidney injury requiring renal replacement therapy
Measured: During hospitalization within 30 days
Hemolysis
- Hemolysis as measured by haptoglobin, bilirubin, lactate dehydrogenase, and direct antiglobulin
Measured: within 24 hours of admission
cerebrovascular accident
Measured: During hospitalization within 30 days
acute coronary syndrome
Measured: During hospitalization within 30 days
transfusion-related lung injury
Measured: During hospitalization within 30 days
transfusion-associated cardiac overload
Measured: During hospitalization within 30 days
Duration of need for renal replacement therapy
Measured: During hospitalization within 30 days
Duration of need for mechanical ventilation
Measured: During hospitalization within 30 days
Duration ICU admission
Measured: During hospitalization
Duration hospital admission
Measured: During hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study start18 Oct 2017
- Primary completion24 Aug 2019
- Study completion24 Aug 2019
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.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02926274
- Sponsor's protocol ID
- NTI-JWMRP-201501
- Status last verified
- Mar 2025
- First submitted
- 29 Aug 2016
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Fully deidentified data will be available to other researchers upon request
Publications
Siletz AE, Blair KJ, Cooper RJ, Nguyen NC, Lewis SJ, Fang A, Ward DC, Jackson NJ, Rodriguez T, Grotts J, Hwang J, Ziman A, Cryer HM. A pilot study of stored low titer group O whole blood + component therapy versus component therapy only for civilian trauma patients. J Trauma Acute Care Surg. 2021 Oct 1;91(4):655-662. doi: 10.1097/TA.0000000000003334.
PubMed 34225348
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transfusion of Stored Whole Blood in a Civilian Trauma Center: A Prospective Evaluation of Feasibility and Outcomes
- ClinicalTrials.gov ID
- NCT02926274
- Acronym / sponsor ID
- NTI-JWMRP-201501
- Conditions
- Trauma, Hemorrhage, Coagulopathy
- Keywords
- whole blood, trauma, transfusion, coagulopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 18 Oct 2017 (actual)
- Primary completion
- 24 Aug 2019 (actual)
- Study completion
- 24 Aug 2019 (actual)
- First posted
- 6 Oct 2016 (estimated)
- 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.
Massive hemorrhage is a major cause of potentially preventable death following trauma. A common consequence of hemorrhagic shock is uncontrollable bleeding from coagulopathy, leading to death from exsanguination. Even when bleeding is controlled, patients are at increased risk of complications and mortality. Reconstituted whole blood, or component therapy with packed red blood cells (PRBCs), plasma, and platelets was introduced by the military in recent conflicts in Iraq and Afghanistan with remarkable results and has been adopted by most civilian trauma centers. Despite improving coagulopathy, it is apparent that transfusion of blood components is not equivalent to whole blood transfusion. Transfusion of high plasma volumes may be associated with increased risk of allergic reaction, transfusion associated acute lung injury (TRALI), hypervolemic cardiac failure, and acute respiratory distress syndrome (ARDS). Military services have recently reintroduced fresh whole blood (WB) for standard resuscitation of massive hemorrhage, have found that WB offers a survival advantage over component therapy, and that risks of transfusion reactions are similar for WB and PRBCs. On the civilian side, whole blood is an FDA-licensed product that has been in use in pediatric open heart surgery and autologous blood donation but is no longer commonly available for other indications. However, the military results are renewing interest in whole blood for trauma resuscitation. The use of low-antibody titer whole blood leukoreduced with a platelet-sparing filter was recently approved by the University of California Los Angeles Blood and Blood Derivatives Committee and two other trauma centers for male trauma patients. This study will test the feasibility of providing stored WB for resuscitation of patients in hemorrhagic shock and determine the effects of WB on clinical outcomes as well as the effects on coagulation, fibrinolysis, and inflammation, compared to standard blood component therapy.
Detailed description
Most current massive transfusion protocols attempt to treat the early coagulopathic state induced by severe injury and hemorrhagic shock with transfusion of red blood cells, plasma, and platelets in a 1:1:1 ratio replicating whole blood. Civilian trauma centers have now begun to initiate resuscitation of adult male patients with stored whole blood as a standard of care, however.
The main hypothesis behind this change in practice is that transfusion of whole blood (WB) rather than attempted reconstitution from its banked components is safer, more efficient and effective treatment of hemorrhagic shock following injury and will result in less frequent development of clinical coagulopathy and subsequent mortality. Whole blood offers the advantages of more precisely approximating shed blood; decreased volume of additives per unit; and exposure to a decreased number of donors for a patient undergoing massive transfusion. It remains to be seen whether this will translate into differences in coagulopathy, inflammation, and mortality. The purpose of this study is to investigate the feasibility of developing a system to collect, store, and deliver whole blood for trauma resuscitations in a civilian trauma center.
The universal donor blood type for patients with unknown blood type is type O positive blood for males and O negative for females. Because O negative blood is rare the study will initiate the change in practice in adult male patients and later extend it to female patients if feasible. The study will determine the effects of WB transfusion in adult male patients compared to transfusion of PRBCS, plasma, and platelets in a 1:1:1 ratio in non adult male patients on markers of coagulation, fibrinolysis, and inflammation, as well as the development of complications and hospital mortality following severe injury.
Specific aims are to:
- Determine the appropriate shelf life of WB that has been leukoreduced with a platelet sparing filter by measuring changes in levels of coagulation factors and global clotting potential of banked units over time. To accomplish this the investigators will measure variables known to reflect potential and actual clotting capacity including platelet function and overall clotting ability by thromboelastography (TEG) and thrombin generation analysis in whole blood up to 35 days.
- Prospectively determine the effectiveness of trauma resuscitation using WB compared to component therapy and its effects on variables known to reflect potential and actual clotting capacity including markers of coagulation, fibrinolysis, inflammation, platelet function and global hemostatic potential post transfusion, as well as hospital outcomes including development of coagulopathy, infection, venous thromboembolism (VTE), multiple organ failure (MOF), total transfusion requirements, and mortality.
- Test the feasibility and implementation of a system to provide WB for resuscitation of trauma patients in hemorrhagic shock in civilian trauma centers. This will be accomplished by monitoring cost, storage needs, frequency of blood collection, number of donors, inventory, utilization and wastage of unused units.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole Blood | – | –Adult male trauma patients presenting with systolic blood pressure <100 will receive up to 6 units of whole blood when available. |
| Component therapy | – | –Adult female patients presenting with systolic blood pressure <100, as well as adult male patients with systolic blood pressure <100 during periods when whole blood is not available, will receive component therapy (1:1:1 packed red blood cells: plasma:platelets) for transfusion. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All trauma patients presenting to Ronald Reagan UCLA Medical Center with systolic blood pressure <100 suspected due to hemorrhage are eligible. Adult males will receive whole blood when available. Adult female patients will receive component therapy.
Key inclusion criteria (1 listed)
- All adult trauma patients presenting to Ronald Reagan University of California Los Angeles (UCLA) Medical Center with systolic blood pressure <100 suspected due to hemorrhage are eligible. Adult males will receive whole blood when available. Adult female patients will receive component therapy.
Key exclusion criteria (1 listed)
- Burn patients, patients with medical bracelets or other directives refusing blood transfusion if known during emergent resuscitation for traumatic injury, pediatric patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Volume of blood products transfused during resuscitation
Time frame: From admission to 24 hours after admission
Volume of blood products transfused (whole blood, packed red blood cells, platelets, and plasma) within the first 24 hours of admission.
20 secondary outcomes
mortality
Time frame: Mortality at 30 days after injury
platelet mapping by thromboelastography
Time frame: within one day of injury, after 6 units of whole blood or packed red blood cell transfusion, or after hemostasis is achieved if less than 6 units are required
Thromboelastography reaction time
Time frame: within one day of injury, after 6 units of whole blood or packed red blood cell transfusion, or after hemostasis is achieved if less than 6 units are required
Thromboelastography K value
Time frame: within one day of injury, after 6 units of whole blood or packed red blood cell transfusion, or after hemostasis is achieved if less than 6 units are required
Thromboelastography maximum amplitude (MA)
Time frame: within one day of injury, after 6 units of whole blood or packed red blood cell transfusion, or after hemostasis is achieved if less than 6 units are required
total units of blood products transfused (includes whole blood, packed red blood cells, plasma, platelets, and cryoprecipitate).
Time frame: 3 and 6 hours after admission, 24 hours after admission, and total for hospital stay within 30 days of injury
venous thromboembolism
Time frame: any venous thromboembolism occurring during hospitalization within 30 days of injury.
infection (documentation of suspected or confirmed infection in the medical chart including urinary tract infection, pneumonia, wound infection, infectious colitis, and bacteremia).
Time frame: during hospitalization within 30 days of injury.
Development of clinical coagulopathy
Time frame: Within 24 hours of injury, and during hospitalization within 30 days
Development of Acute Respiratory Distress Syndrome
Time frame: During hospitalization within 30 days
Development of acute kidney injury requiring renal replacement therapy
Time frame: During hospitalization within 30 days
Hemolysis
Time frame: within 24 hours of admission
cerebrovascular accident
Time frame: During hospitalization within 30 days
acute coronary syndrome
Time frame: During hospitalization within 30 days
transfusion-related lung injury
Time frame: During hospitalization within 30 days
transfusion-associated cardiac overload
Time frame: During hospitalization within 30 days
Duration of need for renal replacement therapy
Time frame: During hospitalization within 30 days
Duration of need for mechanical ventilation
Time frame: During hospitalization within 30 days
Duration ICU admission
Time frame: During hospitalization
Duration hospital admission
Time frame: During hospitalization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Derived from this study: PubMed 34225348Siletz AE, Blair KJ, Cooper RJ, Nguyen NC, Lewis SJ, Fang A, Ward DC, Jackson NJ, Rodriguez T, Grotts J, Hwang J, Ziman A, Cryer HM. A pilot study of stored low titer group O whole blood + component therapy versus component therapy only for civilian trauma patients. J Trauma Acute Care Surg. 2021 Oct 1;91(4):655-662. doi: 10.1097/TA.0000000000003334.
- Individual participant dataSharing planned: Yes. Fully deidentified data will be available to other researchers upon request
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma and Hemorrhage, run by University of California, Los Angeles at 1 site in United States.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 27 Mar 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 United States. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume of blood products transfused during resuscitation (time frame: From admission to 24 hours after 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 NCT02926274, 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 Mar 2025.