Status:
COMPLETED
Shock, Whole Blood, and Assessment of TBI S.W.A.T. (LITES TO 2)
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
United States Department of Defense
Conditions:
Hemorrhagic Shock
Traumatic Brain Injury
Eligibility:
All Genders
15-90 years
Brief 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 ...
Detailed Description
Background 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 ...
Eligibility Criteria
Inclusion
- Patients with blunt or penetrating injury who meet the following criteria: 1, 2, and 3
- Has 2 or more of any of the following:
- Hypotension (systolic blood pressure ≤ 90 mmHg) in the prehospital or emergency department setting,
- Penetrating mechanism,
- Positive FAST abdominal ultrasound,
- Heart Rate ≥ 120 in the prehospital or emergency department setting.
- AND
- Taken to the Operating Room (laparotomy, thoracotomy or vascular exploration) or Interventional Radiology within 60 minutes of arrival.
- AND
- Need of blood/blood component transfusion in prehospital setting, ED or OR within 60 minutes of arrival.
Exclusion
- Age ≤ 14
- CPR \> 5 consecutive minutes without ROSC
- Penetrating brain injury with brain matter exposed
- ED death
Key Trial Info
Start Date :
May 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 2 2022
Estimated Enrollment :
1051 Patients enrolled
Trial Details
Trial ID
NCT03402035
Start Date
May 1 2018
End Date
March 2 2022
Last Update
February 8 2024
Active Locations (1)
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1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213