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NCT03402035 · ClinicalTrials.gov registry record
Shock, Whole Blood, and Assessment of TBI S.W.A.T. (LITES TO 2)
A clinical trial, sponsored by University of Pittsburgh.
- Completed
- Registry status
- 1,051
- Enrollment target
NCT03402035: Completed study, sponsored by University of Pittsburgh.
NCT03402035 is a clinical trial that has completed, run by University of Pittsburgh. The registered enrollment target is 1,051 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03402035 has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- 1,051 participants
- Enrollment target
Study 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
Primary Outcome
mortality at 4 hours
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,051 participants |
| Start Date | 2018-05-01 |
| Est. Completion | 2022-03-02 |
What the finished NCT03402035 record still lists
NCT03402035 is an observational study that tracks outcomes without assigning an intervention. Its 1,051 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 0 interventions.
NCT03402035 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03402035 about?
NCT03402035 is a clinical study titled "Shock, Whole Blood, and Assessment of TBI S.W.A.T. (LITES TO 2)". 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 respo...
What is the current status of trial NCT03402035?
This trial is currently completed. The enrollment target is 1,051 participants. The study started on 2018-05-01. Estimated completion is 2022-03-02.
Who is sponsoring clinical trial NCT03402035?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
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