Trial Outcomes & Findings for Shock, Whole Blood, and Assessment of TBI S.W.A.T. (LITES TO 2) (NCT NCT03402035)

NCT ID: NCT03402035

Last Updated: 2024-02-08

Results Overview

mortality at 4 hours

• Recruitment status: COMPLETED
• Target enrollment: 1051 participants
• Primary outcome timeframe: 4 hours
• Results posted on: 2024-02-08

Participant Flow

Participant milestones

Measure	Whole Blood Subjects that received whole blood for hemorrhagic shock	Component Therapy Subjects that received component therapy for hemorrhagic shock
Overall Study STARTED	624	427
Overall Study COMPLETED	624	427
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Whole Blood n=624 Participants Subjects that received whole blood for hemorrhagic shock	Component Therapy n=427 Participants Subjects that received component therapy for hemorrhagic shock	Total n=1051 Participants Total of all reporting groups
Age, Continuous	35.0 years n=5 Participants	35.0 years n=7 Participants	35.0 years n=5 Participants
Sex: Female, Male Female	78 Participants n=5 Participants	130 Participants n=7 Participants	208 Participants n=5 Participants
Sex: Female, Male Male	546 Participants n=5 Participants	297 Participants n=7 Participants	843 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	225 Participants n=5 Participants	139 Participants n=7 Participants	364 Participants n=5 Participants
Race (NIH/OMB) White	280 Participants n=5 Participants	235 Participants n=7 Participants	515 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	119 Participants n=5 Participants	53 Participants n=7 Participants	172 Participants n=5 Participants
Region of Enrollment United States	624 participants n=5 Participants	427 participants n=7 Participants	1051 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 hours

mortality at 4 hours

Outcome measures

Measure	Whole Blood n=624 Participants Subjects that received whole blood for hemorrhagic shock	Component Therapy n=427 Participants Subjects that received component therapy for hemorrhagic shock
4 Hour Mortality	50 Participants	32 Participants

SECONDARY outcome

Timeframe: 24 hours

mortality at 24 hours

Outcome measures

Measure	Whole Blood n=624 Participants Subjects that received whole blood for hemorrhagic shock	Component Therapy n=427 Participants Subjects that received component therapy for hemorrhagic shock
24 Hour Mortality	82 Participants	49 Participants

Adverse Events

Whole Blood

Serious events: 87 serious events

Other events: 0 other events

Deaths: 110 deaths

Component Therapy

Serious events: 48 serious events

Other events: 0 other events

Deaths: 66 deaths

Serious adverse events

Measure	Whole Blood n=624 participants at risk Subjects that received whole blood for hemorrhagic shock	Component Therapy n=427 participants at risk Subjects that received component therapy for hemorrhagic shock
Blood and lymphatic system disorders Deep Vein Thrombosis	7.9% 49/624 • Number of events 49 • 28 days	5.2% 22/427 • Number of events 22 • 28 days
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	6.1% 38/624 • Number of events 38 • 28 days	6.1% 26/427 • Number of events 26 • 28 days

Other adverse events

Adverse event data not reported

Additional Information

Jason Sperry

University of Pittsburgh

Phone: 4128028270

Email: sperryjl@upmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place