CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 35 enrolled
Drug / intervention
CoSeal Surgical Spray Groupdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01330433
NCT01330433Phase 2Completed
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Effects of CoSeal in Reducing Perioperative Bleeding & Adhesions in Pediatric Heart Surgery

Loma Linda University·interventional·Posted Apr 7, 2011·Updated Dec 15, 2016

In Brief

A Phase 2 clinical trial evaluating CoSeal Surgical Spray Group for Congenital Heart Defect and 2 related conditions. Completed, enrolled 35 participants across 1 site.

Detailed Summary

This is a prospective, randomized, open-label, blinded-evaluator study that will evaluate the effectiveness of a surgical sealant (CoSeal) composed of biocompatible polyethylene glycol on the formation of mediastinal and pericardial adhesions in children undergoing staged surgical reconstruction (potential procedures include: Blalock-Taussig Type Operation, Classical Glenn Procedure, Bidirectional Glenn Procedure, Norwood). Additionally, bleeding will be evaluated by drainage post-operatively through surgical site drainage output.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCongenital Heart Defect, Surgery-Induced Tissue Adhesions, Hemorrhage
CountriesUnited States
CollaboratorsBaxter Healthcare Corporation

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 7, 2011
Enrollment StartAug 1, 2011
Primary CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 15.2 years ago

Interventions

CoSeal Surgical Spray Groupdevice

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