Effects of CoSeal on Bleeding & Adhesions in Pediatric Heart Surgery

This study is ongoing, but not recruiting participants.
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: August 28, 2014
Last verified: August 2014
  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:


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 Primary Completion Date: February 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
Loma Linda University Medical Center
Loma Linda, California, United States, 92602
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: August 28, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 22, 2014