Shock, Whole Blood, and Assessment of TBI S.W.A.T. (LITES TO 2)

NCT03402035 | Completed Results DMC

• 1 other identifier: PRO17090104
• Study Type: observational
• Target: 1,051
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Hemorrhagic Shock; Traumatic Brain Injury

Keywords

Whole Blood Resuscitation

Outcome Measures

Primary Outcomes (1)

• 4 Hour Mortality

  mortality at 4 hours

  4 hours

Secondary Outcomes (1)

• 24 Hour Mortality

  24 hours

Study Arms (2)

Whole Blood

Subjects at enrolling centers that utilize whole blood for hemorrhagic shock

Component Therapy

Subjects at enrolling centers that utilize component therapy for hemorrhagic shock

Eligibility Criteria

• Age: 15 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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 resuscitation.

You may qualify if:

• 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.

You may not qualify if:

• Age ≤ 14
• CPR \> 5 consecutive minutes without ROSC
• Penetrating brain injury with brain matter exposed
• ED death

Sponsors & Collaborators

• University of Pittsburgh: lead
• United States Department of Defense: collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Mechanistic Banked Samples Mechanistic Biomarkers

MeSH Terms

Conditions

Shock, Hemorrhagic; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Results Point of Contact

• Title: Jason Sperry
• Organization: University of Pittsburgh

sperryjl@upmc.edu

4128028270

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 14, 2017
• First Posted: January 17, 2018
• Study Start: May 1, 2018
• Primary Completion: September 26, 2021
• Study Completion: March 2, 2022
• Last Updated: February 8, 2024
• Results First Posted: February 8, 2024

Record last verified: 2023-06

Locations

US (1)