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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03402035
Recruitment Status : Active, not recruiting
First Posted : January 17, 2018
Last Update Posted : February 11, 2022
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Jason Sperry, University of Pittsburgh

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.


Condition or disease
Hemorrhagic Shock Traumatic Brain Injury

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 1050 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Shock, Whole Blood and Assessment of TBI- S.W.A.T.- Linking Investigations in Trauma and Emergency Services (LITES) Task Order 2
Actual Study Start Date : May 1, 2018
Actual Primary Completion Date : September 26, 2021
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Group/Cohort
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



Primary Outcome Measures :
  1. 4 hour mortality [ Time Frame: 4 hours ]
    mortality at 4 hours


Secondary Outcome Measures :
  1. 24 hour mortality [ Time Frame: 24 hours ]
    mortality at 24 hours

  2. 24 hour blood and blood component transfusion requirements [ Time Frame: 24 hours ]
    Transfusion requirements of blood and blood components in first 24 hours of admission

  3. Glasgow Outcome Score - 6 months [ Time Frame: 6 month ]
    long term Glasgow Outcome Score at 6 months from admission

  4. In hospital mortality [ Time Frame: up to 250 days ]
    Death in the hospital


Biospecimen Retention:   Samples Without DNA
Mechanistic Banked Samples Mechanistic Biomarkers


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03402035


Locations
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United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
United States Department of Defense
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Responsible Party: Jason Sperry, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03402035    
Other Study ID Numbers: PRO17090104
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: February 11, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jason Sperry, University of Pittsburgh:
Whole Blood Resuscitation
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Shock
Shock, Hemorrhagic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Pathologic Processes
Hemorrhage