Trial Outcomes & Findings for Pragmatic Prehospital Group O Whole Blood Early Resuscitation Trial (NCT NCT03477006)

NCT ID: NCT03477006

Last Updated: 2021-10-06

Results Overview

28 day all cause mortality

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 86 participants
• Primary outcome timeframe: 28 days from admission
• Results posted on: 2021-10-06

Participant Flow

Participant milestones

Measure	LTLR-WB Receiving 2 units of low titer, leucocyte reduced, platelet replete whole blood initiated in the prehospital setting during air medical transport and continued (up to 6 units of whole blood followed by standard component resuscitation) thru the early in-hospital phase of care Whole blood: Low titer, group O, leukocyte reduced, platelet replete, cold stored whole blood	Standard Care Receiving standard prehospital air medical care and standard of care component (1:1:1) trauma resuscitation thru the early in-hospital phase of care
Overall Study STARTED	40	46
Overall Study COMPLETED	40	46
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pragmatic Prehospital Group O Whole Blood Early Resuscitation Trial

Baseline characteristics by cohort

Measure	LTLR-WB n=40 Participants Receiving 2 units of low titer, leucocyte reduced, platelet replete whole blood initiated in the prehospital setting during air medical transport and continued (up to 6 units of whole blood followed by standard component resuscitation) thru the early in-hospital phase of care Whole blood: Low titer, group O, leukocyte reduced, platelet replete, cold stored whole blood	Standard Care n=46 Participants Receiving standard prehospital air medical care and standard of care component (1:1:1) trauma resuscitation thru the early in-hospital phase of care	Total n=86 Participants Total of all reporting groups
Age, Continuous	46 years n=5 Participants	51 years n=7 Participants	48.5 years n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	31 Participants n=7 Participants	54 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	15 Participants n=7 Participants	32 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	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	34 Participants n=5 Participants	43 Participants n=7 Participants	77 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	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants	46 participants n=7 Participants	86 participants n=5 Participants

PRIMARY outcome

Timeframe: 28 days from admission

28 day all cause mortality

Outcome measures

Measure	LTLR-WB n=40 Participants Receiving 2 units of low titer, leucocyte reduced, platelet replete whole blood initiated in the prehospital setting during air medical transport and continued (up to 6 units of whole blood followed by standard component resuscitation) thru the early in-hospital phase of care Whole blood: Low titer, group O, leukocyte reduced, platelet replete, cold stored whole blood	Standard Care n=46 Participants Receiving standard prehospital air medical care and standard of care component (1:1:1) trauma resuscitation thru the early in-hospital phase of care
28 Day All Cause Mortality	10 Participants	12 Participants

SECONDARY outcome

Timeframe: 28 days from admission

multiple organ failure using the Denver post-injury MOF score which is a summed score and when the score is 4 or greater from 4 organ system scores, MOF is designated; 4 organ systems (pulmonary [0-3], renal [0-3], hepatic [0-3], cardiovascular [0-3])

Outcome measures

Measure	LTLR-WB n=40 Participants Receiving 2 units of low titer, leucocyte reduced, platelet replete whole blood initiated in the prehospital setting during air medical transport and continued (up to 6 units of whole blood followed by standard component resuscitation) thru the early in-hospital phase of care Whole blood: Low titer, group O, leukocyte reduced, platelet replete, cold stored whole blood	Standard Care n=46 Participants Receiving standard prehospital air medical care and standard of care component (1:1:1) trauma resuscitation thru the early in-hospital phase of care
Incidence of Multiple Organ Failure	4 Participants	9 Participants

SECONDARY outcome

Timeframe: 24 hours from admission

24 hour mortality

Outcome measures

Measure	LTLR-WB n=40 Participants Receiving 2 units of low titer, leucocyte reduced, platelet replete whole blood initiated in the prehospital setting during air medical transport and continued (up to 6 units of whole blood followed by standard component resuscitation) thru the early in-hospital phase of care Whole blood: Low titer, group O, leukocyte reduced, platelet replete, cold stored whole blood	Standard Care n=46 Participants Receiving standard prehospital air medical care and standard of care component (1:1:1) trauma resuscitation thru the early in-hospital phase of care
24 Hour Mortality	6 Participants	8 Participants

Adverse Events

LTLR-WB

Serious events: 7 serious events

Other events: 0 other events

Deaths: 10 deaths

Standard Care

Serious events: 11 serious events

Other events: 1 other events

Deaths: 12 deaths

Serious adverse events

Measure	LTLR-WB n=40 participants at risk Receiving 2 units of low titer, leucocyte reduced, platelet replete whole blood initiated in the prehospital setting during air medical transport and continued (up to 6 units of whole blood followed by standard component resuscitation) thru the early in-hospital phase of care Whole blood: Low titer, group O, leukocyte reduced, platelet replete, cold stored whole blood	Standard Care n=46 participants at risk Receiving standard prehospital air medical care and standard of care component (1:1:1) trauma resuscitation thru the early in-hospital phase of care
Nervous system disorders stroke	2.5% 1/40 • Number of events 1 • During Hospital admission up to 28 days	6.5% 3/46 • Number of events 3 • During Hospital admission up to 28 days
Respiratory, thoracic and mediastinal disorders ARDS	7.5% 3/40 • Number of events 3 • During Hospital admission up to 28 days	2.2% 1/46 • Number of events 1 • During Hospital admission up to 28 days
Blood and lymphatic system disorders DVT	2.5% 1/40 • Number of events 1 • During Hospital admission up to 28 days	6.5% 3/46 • Number of events 3 • During Hospital admission up to 28 days
Respiratory, thoracic and mediastinal disorders pulmonary embolus	2.5% 1/40 • Number of events 1 • During Hospital admission up to 28 days	2.2% 1/46 • Number of events 1 • During Hospital admission up to 28 days
Musculoskeletal and connective tissue disorders Rhabdomyolysis	2.5% 1/40 • Number of events 1 • During Hospital admission up to 28 days	4.3% 2/46 • Number of events 2 • During Hospital admission up to 28 days
Gastrointestinal disorders gastrointestinal bleed	0.00% 0/40 • During Hospital admission up to 28 days	2.2% 1/46 • Number of events 1 • During Hospital admission up to 28 days

Other adverse events

Measure	LTLR-WB n=40 participants at risk Receiving 2 units of low titer, leucocyte reduced, platelet replete whole blood initiated in the prehospital setting during air medical transport and continued (up to 6 units of whole blood followed by standard component resuscitation) thru the early in-hospital phase of care Whole blood: Low titer, group O, leukocyte reduced, platelet replete, cold stored whole blood	Standard Care n=46 participants at risk Receiving standard prehospital air medical care and standard of care component (1:1:1) trauma resuscitation thru the early in-hospital phase of care
Metabolism and nutrition disorders hyponatremia	0.00% 0/40 • During Hospital admission up to 28 days	2.2% 1/46 • Number of events 1 • During Hospital admission up to 28 days

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