Trial Outcomes & Findings for Modified Perfusion for Neonatal Aortic Arch Reconstruction (NCT NCT00490256)

NCT ID: NCT00490256

Last Updated: 2014-06-03

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 14 participants
• Primary outcome timeframe: Baseline and 0, 3, 12, and 24 hours after surgery
• Results posted on: 2014-06-03

Participant Flow

Participant milestones

Measure	Control Arm 1 is the control arm. This arm will receive the standard cardiopulmonary bypass circuit.	Experimental This arm is the modified selective perfusion arm. This arm will receive the modified cardiopulmonary circuit.
Overall Study STARTED	7	7
Overall Study Intraoperative Portion of the Study	7	7
Overall Study COMPLETED	7	7
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Modified Perfusion for Neonatal Aortic Arch Reconstruction

Baseline characteristics by cohort

Measure	Control n=7 Participants Arm 1 is the control arm. This arm will receive the standard cardiopulmonary bypass circuit.	Experimental n=7 Participants This arm is the modified selective perfusion arm. This arm will receive the modified cardiopulmonary circuit.	Total n=14 Participants Total of all reporting groups
Age, Categorical <=18 years	7 Participants n=5 Participants	7 Participants n=7 Participants	14 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	9.9 years STANDARD_DEVIATION 8.5 • n=5 Participants	4.7 years STANDARD_DEVIATION 2.9 • n=7 Participants	7.3 years STANDARD_DEVIATION 6.6 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants	7 participants n=7 Participants	14 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 0, 3, 12, and 24 hours after surgery

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Immediate postop

intestinal fatty acid binding protein level immediately postop

Outcome measures

Measure	Control n=7 Participants Arm 1 is the control arm. This arm will receive the standard cardiopulmonary bypass circuit.	Experimental n=7 Participants This arm is the modified selective perfusion arm. This arm will receive the modified cardiopulmonary circuit.
iFAB Post-op	1590 mcg/ml Standard Deviation 1188	564 mcg/ml Standard Deviation 272

SECONDARY outcome

Timeframe: 24 hours

Outcome measures

Outcome data not reported

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Experimental

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Paul Kirshbom, MD

Emory University

Phone: 404-785-6330

Email: pkirshb@emory.edu

Results disclosure agreements

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