- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02926274
Transfusion Using Stored Whole Blood
Transfusion of Stored Whole Blood in a Civilian Trauma Center: A Prospective Evaluation of Feasibility and Outcomes
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90095
- Ronald Reagan UCLA Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Burn patients, patients with medical bracelets or other directives refusing blood transfusion if known during emergent resuscitation for traumatic injury, pediatric patients
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Whole Blood
Adult male trauma patients presenting with systolic blood pressure <100 will receive up to 6 units of whole blood when available.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Volume of blood products transfused during resuscitation
Time Frame: From admission to 24 hours after admission
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Volume of blood products transfused (whole blood, packed red blood cells, platelets, and plasma) within the first 24 hours of admission.
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From admission to 24 hours after admission
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
mortality
Time Frame: Mortality at 30 days after injury
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Mortality at 30 days after injury
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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
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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).
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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
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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
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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).
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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
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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
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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).
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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
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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
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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).
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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
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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
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3 and 6 hours after admission, 24 hours after admission, and total for hospital stay within 30 days of injury
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venous thromboembolism
Time Frame: any venous thromboembolism occurring during hospitalization within 30 days of injury.
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any venous thromboembolism occurring during hospitalization within 30 days of injury.
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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.
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during hospitalization within 30 days of injury.
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Development of clinical coagulopathy
Time Frame: Within 24 hours of injury, and during hospitalization within 30 days
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Documentation of diffuse clinical bleeding or documented clinical coagulopathy based on laboratory evidence by the primary team
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Within 24 hours of injury, and during hospitalization within 30 days
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Development of Acute Respiratory Distress Syndrome
Time Frame: During hospitalization within 30 days
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During hospitalization within 30 days
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Development of acute kidney injury requiring renal replacement therapy
Time Frame: During hospitalization within 30 days
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During hospitalization within 30 days
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Hemolysis
Time Frame: within 24 hours of admission
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7. Hemolysis as measured by haptoglobin, bilirubin, lactate dehydrogenase, and direct antiglobulin
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within 24 hours of admission
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cerebrovascular accident
Time Frame: During hospitalization within 30 days
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During hospitalization within 30 days
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acute coronary syndrome
Time Frame: During hospitalization within 30 days
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During hospitalization within 30 days
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transfusion-related lung injury
Time Frame: During hospitalization within 30 days
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During hospitalization within 30 days
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transfusion-associated cardiac overload
Time Frame: During hospitalization within 30 days
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During hospitalization within 30 days
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Duration of need for renal replacement therapy
Time Frame: During hospitalization within 30 days
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During hospitalization within 30 days
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Duration of need for mechanical ventilation
Time Frame: During hospitalization within 30 days
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During hospitalization within 30 days
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Duration ICU admission
Time Frame: During hospitalization
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During hospitalization
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Duration hospital admission
Time Frame: During hospitalization
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During hospitalization
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NTI-JWMRP-201501
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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