Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
The LITES Network is an operational trauma center consortium which has the expertise, track
record and confirmed capabilities to conduct prospective, multicenter, injury care and
outcomes research of relevance to the Department of Defense (DoD).
Hemorrhage and Traumatic Brain Injury (TBI) are responsible for the largest proportion of all
trauma-related deaths. It is the poly-trauma patient who suffers both hemorrhagic shock and
traumatic brain injury where a paucity of evidence exists to direct treatment, limiting the
development of beneficial trauma practice guidelines.
The use of Whole Blood (WB) for early trauma resuscitation has been touted as the 'essential
next step' in the evolution of trauma resuscitation. Despite its historical and more recent
use, little is known regarding WB's benefit relative to the 'current practice' ratio-based
blood component therapy in the acutely bleeding patient, and even less is known regarding its
effects in patients with TBI.
AIM#1: Evaluate patient centered outcomes associated with early whole blood resuscitation
practice as compared to component resuscitation in poly-trauma patients with hemorrhagic
shock and further characterize outcome benefits in those with traumatic brain injury.
AIM#2: Characterize blood pressure and resuscitation endpoints during the acute resuscitation
phase of care and the associated/attributable outcomes for traumatic brain injury in patients
with hemorrhagic shock.
General Hypothesis #1: Whole blood resuscitation will be associated with improved mortality
and resuscitation outcomes in poly-trauma patients and long term neurological outcome in
those patients with traumatic brain injury as compared to those resuscitated with component
therapy.
General Hypothesis #2: Differences in prehospital and acute phase resuscitation systolic
blood pressure will be associated with differential outcomes in patients with traumatic brain
injury at discharge and at 6 months.
Study Design: The LITES network will perform a multicenter, prospective, observational cohort
study over a 4 year period to determine the impact of whole blood resuscitation in trauma
patients with hemorrhagic shock at risk of large volume resuscitation with and without TBI.
Early whole blood resuscitation will be compared to standard component resuscitation. The
study will also further characterize blood pressure and resuscitation endpoints in
poly-trauma patients with traumatic brain injury. Six Trauma sites with appropriate
characteristics will be selected from 12 LITES Network sites across the country.
Study Setting: The study will be performed utilizing busy level I trauma centers within the
LITES Network located across the country, at sites where either whole blood has currently
been incorporated into standard of care or where component blood transfusion is being
utilized for patients in hemorrhagic shock at risk for large volume resuscitation.
Study Population: The study will focus on patients who suffer blunt or penetrating injury,
transported to a SWAT participating LITES trauma center with evidence of hemorrhagic shock at
risk of large volume blood resuscitation.
Phase
N/A
Funding Agency/Sponsor
Other
Disease
Trauma and Surgical Critical Care
Enrollment Eligibility
Inclusion Criteria:
Patients with blunt or penetrating injury who meet the following criteria: 1, 2, and 3
1. Has 2 or more of any of the following:
1. Hypotension (systolic blood pressure ≤ 90 mmHg) in the prehospital or emergency
department setting,
2. Penetrating mechanism,
3. Positive FAST abdominal ultrasound,
4. Heart Rate ≥ 120 in the prehospital or emergency department setting.
AND
2. Taken to the Operating Room (laparotomy, thoracotomy or vascular exploration) or
Interventional Radiology within 60 minutes of arrival.
AND
3. Need of blood/blood component transfusion in prehospital setting, ED or OR within 60
minutes of arrival.
Exclusion Criteria:
1. Age ≤ 14
2. CPR > 5 consecutive minutes without ROSC
3. Penetrating brain injury with brain matter exposed
4. ED death