Clinical trial NCT01330433: Effects of CoSeal on Bleeding & Adhesions in Pediatric Heart Surgery
Official title: Effects of CoSeal in Reducing Perioperative Bleeding & Adhesions in Pediatric Heart Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Congenital Heart Defect
Surgery-Induced Tissue Adhesions
Hemorrhage
Lead sponsor: Loma Linda University
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
First posted: 2011-04-07
Enrollment: 35
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Severity of Adhesions at the Retrosternal Site
timeFrame: Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery
measure: Severity of Adhesions at the Arterial Base Site.
timeFrame: Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery
measure: Severity of Adhesions at the Diaphragm Site
timeFrame: Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery
measure: Severity of Adhesions at the Left Lateral Site
timeFrame: Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery
measure: Severity of Adhesions at the Right Lateral Site
timeFrame: Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery
measure: Post-operative Bleeding
timeFrame: Post-operative bleeding data will be collected on average, during the first 36 hours after the surgery
measure: Adhesion Burden
timeFrame: Time it takes for patient to be put on bypass (an average time between 0 and 120 minutes)
Secondary outcomes:
measure: Hospital Stay
timeFrame: Length of stay after second surgery up to 1 month
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
Study officials:
affiliation: Loma Linda University Medical Center
name: Nahidh Hasaniya, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Loma Linda University Medical Center
name: Anees Razzouk, MD
role: STUDY_CHAIR
References: