Effects of CoSeal on Bleeding & Adhesions in Pediatric Heart Surgery



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any - 17
Updated:4/21/2016
Start Date:August 2011
End Date:August 2015

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Trial Summary
Trial Overview
Inclusion Criteria

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.


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
We found this trial at
1
site
Loma Linda University Medical Center
11234 Anderson St
Loma Linda, California 92354
(909) 558-4000
Loma Linda University Medical Center An outgrowth of the original Sanitarium on the hill in...
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mi
from
Loma Linda, CA
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