Effects of CoSeal on Bleeding & Adhesions in Pediatric Heart Surgery

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

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 Overview

• Status: Completed
• Conditions: Hemorrhage; Congenital Heart Defect; Surgery-Induced Tissue Adhesions
• Intervention / Treatment: Device: CoSeal Surgical Spray Group

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92602
      • Loma Linda University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: CoSeal Spray Group; CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 data will be collected during approximately the first 30-60 minutes of the second staged surgery
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 data will be collected during approximately the first 30-60 minutes of the second staged surgery
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 data will be collected during approximately the first 30-60 minutes of the second staged surgery
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 data will be collected during approximately the first 30-60 minutes of the second staged surgery
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).	Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery
Post-operative Bleeding	Post-operative bleeding through surgical site drainage output.	Post-operative bleeding data will be collected on average, during the first 36 hours after the surgery
Adhesion Burden	Skin to bypass time as an indicator of adhesion burden.	Time it takes for patient to be put on bypass (an average time between 0 and 120 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Stay	Number of days post surgery.	Length of stay after second surgery up to 1 month

Collaborators and Investigators

• Sponsor: Loma Linda University
• Collaborators: Baxter Healthcare Corporation
• Investigators: Principal Investigator: Nahidh Hasaniya, MD, Loma Linda University Medical Center; Study Chair: Anees Razzouk, MD, Loma Linda University Medical Center

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: March 31, 2011
• First Submitted That Met QC Criteria: April 5, 2011
• First Posted (Estimate): April 7, 2011

Study Record Updates

• Last Update Posted (Estimate): December 15, 2016
• Last Update Submitted That Met QC Criteria: October 24, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Fibrosis; Cardiovascular Abnormalities; Cicatrix; Hemorrhage; Heart Defects, Congenital; Tissue Adhesions
• Other Study ID Numbers: 5110074