Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT03477006 |
| Other study ID # |
R34HL135224 |
| Secondary ID |
R34HL135224 |
| Status |
Terminated |
| Phase |
Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
November 20, 2018 |
| Est. completion date |
October 30, 2020 |
Study information
| Verified date |
September 2021 |
| Source |
University of Pittsburgh |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Despite advances in trauma resuscitation, a paucity of therapeutic interventions are
available early enough to reduce the downstream morbidity and mortality attributable to
hemorrhage, shock and coagulopathy. Due to the time sensitive nature of the treatment of
hemorrhage, the ideal resuscitation intervention would entail use of a blood product
containing all essential hemostatic components, closest to time of injury, where prevention
or reversal of the devastating downstream consequences of shock and coagulopathy can occur.
This proposal will characterized the efficacy of whole blood resuscitation initiated in the
prehospital setting to patients in hemorrhagic shock which represents this ideal intervention
post-injury. These results will have great potential to dramatically change the way trauma
resuscitation occurs today.
Description:
Traumatic injury represents an incredible health care burden in the United States and
worldwide. Hemorrhage is estimated to be responsible for over 40% of all trauma-related
deaths. Ongoing traumatic blood loss is complicated by the well-known 'lethal triad' of
coagulopathy, hypothermia and acidosis which results in further unbridled hemorrhage.
Uncontrolled bleeding, resultant shock and organ dysfunction remain the leading causes of
early in-hospital mortality. Despite advances in trauma resuscitation, a paucity of
therapeutic interventions are available early enough to reduce the downstream morbidity and
mortality attributable to hemorrhage, shock and coagulopathy.
In-hospital resuscitation of traumatic hemorrhage has changed over the past decade. The
underlying principle of current resuscitation practice focuses on preventing or reversing the
effects of coagulopathy with the early use of a balanced component transfusion strategy
(1:1:1 - plasma: packed red blood cells: platelets). This reconstituted strategy has also
been coined 'whole blood-like' resuscitation despite being inferior compositionally to whole
blood. The use of whole blood was historically the gold standard for treating hemorrhagic
shock during World War I and II, prior to sweeping changes in blood banking practice. Whole
blood use continues today and is thought to provide the bleeding patient the identical
components they are losing with maximal resuscitative and hemostatic effects.
Recent military experiences continue to show the benefits of fresh whole blood resuscitation
demonstrating significant survival and hemostatic advantages. Whole blood has also been
postulated to improve microcirculatory hemodynamics, reduce the 'storage lesion' effect and
minimize donor exposure risks. A recent civilian study has also demonstrated benefit using
modified whole blood after arrival to the hospital where appropriate blood typing and cross
matching was performed prior to transfusion. Due to the time sensitive nature of the
treatment of hemorrhage, the ideal resuscitation intervention would entail use of a blood
product containing all essential hemostatic components, closest to time of injury, where
prevention or reversal of the devastating downstream consequences of shock and coagulopathy
can occur.
Initiation of whole blood resuscitation in the prehospital setting and continued through the
in-hospital phase of treatment to patients in hemorrhagic shock represents this ideal
intervention post-injury. Essential to the prehospital initiation of whole blood
resuscitation in the civilian population is need for it to be transfused without the need for
blood typing or cross matching. Of similar importance is the need for cold storage and
recycling of any unused whole blood product, allowing maximal utility of this precious
resource.
Based upon the belief that early whole blood resuscitation represents the most efficacious
hemostatic resuscitation product for the management of hemorrhage, the University of
Pittsburgh is currently utilizing cold stored, low titer, platelet replete-leukocyte reduced,
group O whole blood (LTLR-WB) for urgent release in the emergency department, without the
need for blood typing or cross matching, for patients in hemorrhagic shock. The hypothesis is
that the initiation of LTLR-WB resuscitation in the prehospital setting with continuation
through the in-hospital acute resuscitation phase of care will significantly reduce the
morbidity and mortality attributable to hemorrhagic shock post-injury as compared to standard
prehospital and in-hospital resuscitation practice. Thus, a large pragmatic clinical trial is
needed to definitively establish the efficacy and safety of whole blood resuscitation
initiated in the prehospital setting. Only a high quality clinical trial will provide the
essential evidence to justify and provide the impetus for the use of this precious blood
banking resource early post-injury. Because of the challenges associated with execution of
these types of large trials particularly in the prehospital setting, it is essential to
establish feasibility of this approach in a pilot study and provide experience to inform a
definitive large, multicenter whole blood trial. The University of Pittsburgh has a track
record of prehospital interventional trials post-injury and the clinical research
infrastructure to successfully execute the following this trial.
