Trial Outcomes & Findings for Effect of Red Blood Cell Transfusion on Brain Metabolism in Patients With Subarachnoid Hemorrhage (NCT NCT00968227)

NCT ID: NCT00968227

Last Updated: 2017-04-17

Results Overview

Change in oxygen delivery after transfusion in brain regions with low baseline delivery.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 56 participants
• Primary outcome timeframe: 1 hour
• Results posted on: 2017-04-17

Participant Flow

Participant milestones

Measure	Transfusion Red blood cell transfusion: Transfusion of 1 unit of packed red blood cells over 1 hour.
Overall Study STARTED	56
Overall Study COMPLETED	56
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Red Blood Cell Transfusion on Brain Metabolism in Patients With Subarachnoid Hemorrhage

Baseline characteristics by cohort

Measure	Transfusion n=56 Participants Red blood cell transfusion: Transfusion of 1 unit of packed red blood cells over 1 hour.
Age, Continuous	54 years n=5 Participants
Sex: Female, Male Female	42 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	12 Participants n=5 Participants
Race (NIH/OMB) White	44 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	56 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 hour

Change in oxygen delivery after transfusion in brain regions with low baseline delivery.

Outcome measures

Measure	Transfusion n=47 Participants Red blood cell transfusion: Transfusion of 1 unit of packed red blood cells over 1 hour.
Change in Oxygen Delivery in Vulnerable Brain Regions Baseline	3.7 ml/100g/min Standard Deviation 0.5
Change in Oxygen Delivery in Vulnerable Brain Regions Post transfusion	4.3 ml/100g/min Standard Deviation 0.9

SECONDARY outcome

Timeframe: 1 hour

Change in oxygen extraction fraction after transfusion of 1 unit of RBC in regions with low baseline delivery (DO2 < 4.5 ml/100g/min.

Outcome measures

Measure	Transfusion n=34 Participants Red blood cell transfusion: Transfusion of 1 unit of packed red blood cells over 1 hour.
Change in Oxygen Extraction Fraction in Regions With Low Baseline Delivery. Baseline	0.49 fraction Standard Deviation 0.14
Change in Oxygen Extraction Fraction in Regions With Low Baseline Delivery. Post transfusion	0.44 fraction Standard Deviation 0.14

Adverse Events

Transfusion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 4 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michael Diringer PI

Washington University

Phone: 314-362-2999

Email: diringerm@wustl.edu

Results disclosure agreements

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