Effects of CoSeal on Bleeding & Adhesions in Pediatric Heart Surgery

PHASE2CompletedINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

August 31, 2011

Primary Completion Date

August 31, 2015

Study Completion Date

August 31, 2015

Conditions
Congenital Heart DefectSurgery-Induced Tissue AdhesionsHemorrhage
Interventions
DEVICE

CoSeal Surgical Spray Group

"A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.~The dose regimen is as follows:~* Patients weighing \< 3kg will receive 1ml of CoSeal~* Patients weighing 3-10kg will receive 1-2ml of CoSeal~* Patients weighing \>10kg will receive 2-4ml of CoSeal"

Trial Locations (1)

92602

Loma Linda University Medical Center, Loma Linda

All Listed Sponsors
collaborator

Baxter Healthcare Corporation

INDUSTRY

lead

Loma Linda University

OTHER

NCT01330433 - Effects of CoSeal on Bleeding & Adhesions in Pediatric Heart Surgery | Biotech Hunter | Biotech Hunter