Trial Outcomes & Findings for Washed Versus Standard Blood Cell Transfusions in Pediatric Open Heart Surgery (NCT NCT00693498)

Results Overview

plasma was obtained pre-op, immediately once off cardiopulmonary bypass (CPB), six hours following CPB and 12 hours following CPB. The plasma was centrifuged and the supernatant collected and stored at -70 degrees. The samples then underwent Luminex testing for IL-6 and IL-10 levels, and the IL-6:IL-10 ratio was calculated (IL-6 being the numerator and IL-12 being the denominator). The 12 hour ratio was the primary outcome measure.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

162 participants

Primary outcome timeframe

12 hours post-cardiopulmonary bypass

Results posted on

2018-01-08

Participant Flow

Potential subjects were recruited at pre-anesthesia inpatient assessments and outpatient pre-anesthesia appointments.

Participant milestones

Participant milestones
Measure	Standard Transfusion Group Standard leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group	Washed Transfusion Group Washed leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group
Overall Study STARTED	81	81
Overall Study COMPLETED	81	81
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Washed Versus Standard Blood Cell Transfusions in Pediatric Open Heart Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Transfusion Group n=81 Participants Standard leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group	Washed Transfusion Group n=81 Participants Washed leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group	Total n=162 Participants Total of all reporting groups
Age, Categorical <=18 years	81 Participants n=5 Participants	81 Participants n=7 Participants	162 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous Age	1 days FULL_RANGE NA • n=5 Participants	1 days n=7 Participants	1 days n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	18 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	64 Participants n=5 Participants	63 Participants n=7 Participants	127 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 hours post-cardiopulmonary bypass

Population: Only data from those subjects receiving transfusions was analyzed as the study intervention was the type of red blood cell and platelet transfusion (washed v. unwashed).

plasma was obtained pre-op, immediately once off cardiopulmonary bypass (CPB), six hours following CPB and 12 hours following CPB. The plasma was centrifuged and the supernatant collected and stored at -70 degrees. The samples then underwent Luminex testing for IL-6 and IL-10 levels, and the IL-6:IL-10 ratio was calculated (IL-6 being the numerator and IL-12 being the denominator). The 12 hour ratio was the primary outcome measure.

Outcome measures

Outcome measures
Measure	Standard Transfusion Group n=64 Participants Standard leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group	Washed Transfusion Group n=64 Participants Washed leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group
12 Hour Plasma Interleukin (IL)-6 to IL-10 Ratio	8.9 ratio Standard Error 1.2	3.8 ratio Standard Error 1.3

SECONDARY outcome

Timeframe: post op day 1 and 2

Population: 64 subjects in each group that received blood; all included in the analysis

wide range C reactive protein levels were obtained before surgery (pre-operatively) and on post-operative day 1 and 2 in transfused subjects

Outcome measures

Outcome measures
Measure	Standard Transfusion Group n=64 Participants Standard leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group	Washed Transfusion Group n=64 Participants Washed leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group
Median wrCRP Level POD #1	43 mg/dL Interval 0.0 to 300.0	38 mg/dL Interval 0.0 to 85.0
Median wrCRP Level POD #2	70 mg/dL Interval 0.0 to 375.0	59 mg/dL Interval 0.0 to 175.0

Adverse Events

Standard Transfusion Group

Serious events: 6 serious events

Other events: 13 other events

Deaths: 0 deaths

Washed Transfusion Group

Serious events: 2 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Standard Transfusion Group n=81 participants at risk Standard leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group	Washed Transfusion Group n=81 participants at risk Washed leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group
Cardiac disorders Death	7.4% 6/81 • Number of events 6	2.5% 2/81 • Number of events 2

Other adverse events

Other adverse events
Measure	Standard Transfusion Group n=81 participants at risk Standard leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group	Washed Transfusion Group n=81 participants at risk Washed leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group
Infections and infestations Infection	16.0% 13/81 • Number of events 13	16.0% 13/81 • Number of events 13

Additional Information

Jill M. Cholette MD, Principle Investigator

University of Rochester

Phone: 585-275-8138

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place