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Effects of CoSeal on Bleeding & Adhesions in Pediatric Heart Surgery

NCT ID: NCT01330433

Last Updated: 2016-12-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2015-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Congenital Heart Defect Surgery-Induced Tissue Adhesions Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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No CoSeal Surgical Spray

A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.

Group Type NO_INTERVENTION

No interventions assigned to this group

CoSeal Spray Group

CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.

Group Type EXPERIMENTAL

CoSeal Surgical Spray Group

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Have an acceptable surrogate capable of giving consent on the subject's behalf.
* Pediatric patients ages 0 - 17
* Have a cardiac disease which requires staged cardiac surgery and resternotomy
* Non-emergent state or emergent state with sufficient time to educate and consent

Exclusion Criteria

* An immune system disorder
* Unplanned reoperation
* Known hypersensitivity to components in CoSeal
* Patients undergoing reoperation less than 3 months after the primary surgery
Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baxter Healthcare Corporation

INDUSTRY

Sponsor Role collaborator

Loma Linda University

OTHER

Sponsor Role lead

Responsible Party

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Nahidh Hasaniya

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nahidh Hasaniya, MD

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University Medical Center

Anees Razzouk, MD

Role: STUDY_CHAIR

Loma Linda University Medical Center

Locations

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Loma Linda University Medical Center

Loma Linda, California, United States

Site Status

Countries

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United States

Other Identifiers

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5110074

Identifier Type: -

Identifier Source: org_study_id