Transfusion Using Stored Whole Blood
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Hospital, Hematology |
| Therapuetic Areas: | Hematology, Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 10/28/2017 |
| Start Date: | October 18, 2017 |
| End Date: | October 2019 |
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.
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.
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:
1. 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.
2. 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.
3. 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.
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:
1. 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.
2. 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.
3. 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
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