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Effects of CoSeal on Bleeding & Adhesions in Pediatric Heart Surgery

This study is currently recruiting participants.
Verified March 2012 by Loma Linda University
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Nahidh Hasaniya, Loma Linda University
ClinicalTrials.gov Identifier:
NCT01330433
First received: March 31, 2011
Last updated: March 6, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Congenital Heart Defect
Surgery-Induced Tissue Adhesions
Hemorrhage
 Device: CoSeal Surgical Spray Group
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of CoSeal in Reducing Perioperative Bleeding & Adhesions in Pediatric Heart Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Loma Linda University:

Primary Outcome Measures:
  • Severity of adhesions at seven predefined sites [ Time Frame: Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery ] [ Designated as safety issue: No ]
    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).

  • Post-operative bleeding [ Time Frame: Post-operative bleeding data will be collected on average, during the first 36 hours after the surgery ] [ Designated as safety issue: No ]
    Post-operative bleeding through surgical site drainage output.

  • Adhesion Burden [ Time Frame: Time it takes for patient to be put on bypass (an average time between 0 and 120 minutes) ] [ Designated as safety issue: No ]
    Skin to bypass time as an indicator of adhesion burden.


Secondary Outcome Measures:
  • Ease of use [ Time Frame: Data on use of CoSeal will be collected immediately following the surgery (on average 0-60 minutes postoperatively) ] [ Designated as safety issue: No ]
    Ease of use of CoSeal - graded by primary surgeon using a Likert-scale (ranging from 1 [very easy] to 5 [very difficult]).

  • Type and duration of surgery [ Time Frame: Type and duration of surgery is noted during the first 24 hours postoperatively ] [ Designated as safety issue: No ]
    Type and duration of operation and reoperation


Estimated Enrollment: 40
Study Start Date: August 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01330433

Contacts
Contact: Megan Russell, MA 909-558-4354 merussell@llu.edu
Contact: Nahidh Hasaniya, MD 909-558-4354 nhasaniya@llu.edu

Locations
United States, California
Loma Linda University Medical Center Recruiting
Loma Linda, California, United States, 92602
Contact: Megan ET Russell, MA     909-558-4354     merussell@llu.edu    
Contact: Nahidh Hasaniya, MD     909-558-4354     nhasaniya@llu.edu    
Principal Investigator: Nahidh Hasaniya, MD, PhD            
Sub-Investigator: Leonard L Bailey, MD            
Sub-Investigator: Anees Razzouk, MD            
Sub-Investigator: Alfredo Rasi, MD            
Sub-Investigator: Aziz Ghaly, MD            
Sub-Investigator: Rosario Floridia, MD            
Sponsors and Collaborators
Loma Linda University
Baxter Healthcare Corporation
Investigators
Principal Investigator: Nahidh Hasaniya, MD Loma Linda University Medical Center
Study Chair: Anees Razzouk, MD Loma Linda University Medical Center
  More Information

No publications provided

Responsible Party: Nahidh Hasaniya, Associate Professor, Loma Linda University
ClinicalTrials.gov Identifier: NCT01330433     History of Changes
Other Study ID Numbers: 5110074
Study First Received: March 31, 2011
Last Updated: March 6, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Tissue Adhesions
Heart Defects, Congenital
Hemorrhage
Cicatrix
Fibrosis
 Pathologic Processes
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on June 17, 2013