Trial Outcomes & Findings for Erythropoietin and Pediatric Cardiac Surgery (NCT NCT00451698)

NCT ID: NCT00451698

Last Updated: 2018-11-08

Results Overview

Troponin I levels (ng/ml) measured at 4 time points

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 9 participants
• Primary outcome timeframe: 4 postoperative time points up to 48 hours
• Results posted on: 2018-11-08

Participant Flow

Participant milestones

Measure	Acyanotic Placebo Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% \_ Received placebo	Acyanotic Study Drug Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% - Received study drug
Overall Study STARTED	3	6
Overall Study COMPLETED	3	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Erythropoietin and Pediatric Cardiac Surgery

Baseline characteristics by cohort

Measure	Acyanotic Placebo n=3 Participants Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% \_ Received placebo	Acyanotic Study Drug n=6 Participants Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% - Received study drug	Total n=9 Participants Total of all reporting groups
Age, Categorical <=18 years	3 Participants n=5 Participants	6 Participants n=7 Participants	9 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	3.1 years STANDARD_DEVIATION 1.2 • n=5 Participants	12.9 years STANDARD_DEVIATION 4.5 • n=7 Participants	9.6 years STANDARD_DEVIATION 6.1 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	6 participants n=7 Participants	9 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 postoperative time points up to 48 hours

Population: Analysis was limited to descriptive statistics due to low enrollment and study closure.

Troponin I levels (ng/ml) measured at 4 time points

Outcome measures

Measure	Acyanotic Placebo n=3 Participants Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% \_ Received placebo	Acyanotic Study Drug n=6 Participants Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% - Received study drug
Biochemical Markers of Heart Damage 60 minutes post bypass	31.1 ng/ml Standard Deviation 12.2	12.3 ng/ml Standard Deviation 9.2
Biochemical Markers of Heart Damage 4 hrs post bypass	27.2 ng/ml Standard Deviation 8.6	15 ng/ml Standard Deviation 8.2
Biochemical Markers of Heart Damage 24 hrs post bypass	10 ng/ml Standard Deviation 6.2	10.7 ng/ml Standard Deviation 10.4
Biochemical Markers of Heart Damage 48 hrs post bypass	5.2 ng/ml Standard Deviation 1.9	5.2 ng/ml Standard Deviation 5.2

PRIMARY outcome

Timeframe: 4 postoperative time points

Population: There were 43 samples taken from the 9 subjects but no analysis was performed - the laboratory did not set up the assay to run the samples because the study did not have enough subjects to achieve statistical power.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 24 hours postop

Population: These data were not collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 and 48 hours post operative

Population: These data were not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At hospital discharge, up to 30 days

Population: Analysis was limited to descriptive statistics due to low enrollment and study closure.

Outcome measures

Measure	Acyanotic Placebo n=3 Participants Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% \_ Received placebo	Acyanotic Study Drug n=6 Participants Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% - Received study drug
Length of Hospitalization	4.6 days Standard Deviation 1.2	6 days Standard Deviation 5.2

Adverse Events

Acyanotic Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Acyanotic Study Drug

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Acyanotic Placebo n=3 participants at risk Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% \_ Received placebo	Acyanotic Study Drug n=6 participants at risk Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% - Received study drug
Nervous system disorders Seizure	33.3% 1/3 • Number of events 1	0.00% 0/6

Additional Information

Dr. Steven Zangwill

Medical College of Wisconsin

Phone: 414-266-2380

Email: szangwill@chw.org

Results disclosure agreements

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