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NCT Number: NCT01330433

Effects of CoSeal on 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.

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Key information

Conditions

Congenital Heart Defect Cardiovascular Abnormalities Cardiovascular Diseases Cicatrix Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Fibrosis Heart Defects, Congenital Heart Diseases Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Surgery-Induced Tissue Adhesions Tissue Adhesions

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Loma Linda University Medical Center

Loma Linda, California, 92602, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CoSeal Surgical Spray Group

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

Primary outcomes

  1. Severity of Adhesions at the Retrosternal Site

    Time frame: Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery

    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).

  2. Severity of Adhesions at the Arterial Base Site.

    Time frame: Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery

    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).

  3. Severity of Adhesions at the Diaphragm Site

    Time frame: Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery

    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).

  4. Severity of Adhesions at the Left Lateral Site

    Time frame: Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery

    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).

  5. Severity of Adhesions at the Right Lateral Site

    Time frame: Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery

    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).

  6. Post-operative Bleeding

    Time frame: Post-operative bleeding data will be collected on average, during the first 36 hours after the surgery

    Post-operative bleeding through surgical site drainage output.

  7. Adhesion Burden

    Time frame: Time it takes for patient to be put on bypass (an average time between 0 and 120 minutes)

    Skin to bypass time as an indicator of adhesion burden.

Secondary outcomes

  1. Hospital Stay

    Time frame: Length of stay after second surgery up to 1 month

    Number of days post surgery.

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Collaborators

  • Baxter Healthcare Corporation

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Apr 7, 2011
Registry last updated
Dec 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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