Effects of CoSeal on Bleeding & Adhesions in Pediatric Heart Surgery

Back to results

Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

CoSeal Surgical Spray Group

About this trial

This is an interventional treatment trial for Congenital Heart Defect

Eligibility Criteria

undefined - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Loma Linda University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

No CoSeal Surgical Spray

CoSeal Spray Group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Severity of Adhesions at the Retrosternal Site

Severity of adhesions at seven predefined sites (pericardial or retrosternal, inferior or diaphragmatic region, right lateral or arterial region, region around great vessels). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites).

Severity of Adhesions at the Arterial Base Site.

Severity of adhesions at five predefined sites (retrosternal, diaphragmatic region, right lateral, left lateral, arterial base). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites).

Severity of Adhesions at the Diaphragm Site

Severity of adhesions at five predefined sites (retrosternal, diaphragmatic region, right lateral, left lateral, arterial base). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites).

Severity of Adhesions at the Left Lateral Site

Severity of adhesions at five predefined sites (retrosternal, diaphragmatic region, right lateral, left lateral, arterial base). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites).

Severity of Adhesions at the Right Lateral Site

Severity of adhesions at five predefined sites (retrosternal, diaphragmatic region, right lateral, left lateral, arterial base). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites).

Post-operative Bleeding

Post-operative bleeding through surgical site drainage output.

Adhesion Burden

Skin to bypass time as an indicator of adhesion burden.

Secondary Outcome Measures

Hospital Stay

Number of days post surgery.

Full Information

NCT ID

NCT01330433

First Posted

March 31, 2011

Last Updated

October 24, 2016

Sponsor

Loma Linda University

Collaborators

Baxter Healthcare Corporation

1. Study Identification

Unique Protocol Identification Number

NCT01330433

Brief Title

Effects of CoSeal on Bleeding & Adhesions in Pediatric Heart Surgery

Official Title

Effects of CoSeal in Reducing Perioperative Bleeding & Adhesions in Pediatric Heart Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

August 2011 (undefined)

Primary Completion Date

August 2015 (Actual)

Study Completion Date

August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Loma Linda University

Collaborators

Baxter Healthcare Corporation

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Congenital Heart Defect, Surgery-Induced Tissue Adhesions, Hemorrhage

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

No CoSeal Surgical Spray

Arm Type

No Intervention

Arm Description

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.

Arm Title

CoSeal Spray Group

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

CoSeal Surgical Spray Group

Intervention Description

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

Primary Outcome Measure Information:

Title

Severity of Adhesions at the Retrosternal Site

Description

Severity of adhesions at seven predefined sites (pericardial or retrosternal, inferior or diaphragmatic region, right lateral or arterial region, region around great vessels). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites).

Time Frame