Transfusion Using Stored Whole Blood

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.

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