Effects of CoSeal on Bleeding & Adhesions in Pediatric Heart Surgery

Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01330433
• Other study ID #: 5110074
• Status: Completed
• Phase: Phase 2
• First received: March 31, 2011
• Last updated: March 23, 2016
• Start date: August 2011
• Est. completion date: August 2015

Study information

• Verified date: March 2016
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 17 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congenital Heart Defect
• Heart Defects, Congenital
• Hemorrhage
• Surgery-Induced Tissue Adhesions
• Tissue Adhesions

Intervention

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

Locations

Country	Name	City	State
United States	Loma Linda University Medical Center	Loma Linda	California

Sponsors (2)

Lead Sponsor	Collaborator
Loma Linda University	Baxter Healthcare Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of adhesions at seven predefined sites	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	No
Primary	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	No
Primary	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)	No
Secondary	Ease of use	Ease of use of CoSeal - graded by primary surgeon using a Likert-scale (ranging from 1 [very easy] to 5 [very difficult]).	Data on use of CoSeal will be collected immediately following the surgery (on average 0-60 minutes postoperatively)	No
Secondary	Type and duration of surgery	Type and duration of operation and reoperation	Type and duration of surgery is noted during the first 24 hours postoperatively	No