Effects of CoSeal on Bleeding & Adhesions in Pediatric Heart Surgery

Status Completed

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.

Clinical Trial Description

n/a

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01330433
Study type	Interventional
Source	Loma Linda University
Contact
Status	Completed
Phase	Phase 2
Start date	August 2011
Completion date	August 2015

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02815670` - Reversal Dabigatran Anticoagulant Effect With Idarucizumab	Phase 3
Completed	`NCT04588350` - Clinical Investigation Evaluating a New Autotransfusion Device in Cardiac Surgery	N/A
Recruiting	`NCT02972385` - Pharmacogenomics of Warfarin in Hispanics and Latinos
Completed	`NCT02554006` - Predischarge Bundle to Minimize Negative Impact on Quality of Life of Nuisance Bleedings	N/A
Completed	`NCT02569606` - Transfusion and Coagulation Management in Trauma Patients After the Introduction of a Coagulation Algorithm
Recruiting	`NCT02446730` - Efficacy and Safety of BiomatrixTM Stent and 5mg-Maintenance Dose of Prasugrel in Patients With Acute Coronary Syndrome	Phase 4
Completed	`NCT01955720` - Safety, Tolerability, PK and PD of BI 655075 and Establishment of BI 655075 Dose(s) Effective to Reverse Prolongation of Blood Coagulation Time by Dabigatran	Phase 1
Completed	`NCT01935427` - Comparison of Compensatory Reserve Index to Intravascular Volume Change and Stroke Volume	N/A
Recruiting	`NCT01709786` - Non-Invasive Hemoglobin Monitoring in Patients With Hemorrhage	N/A
Completed	`NCT01136590` - Multicenter, Randomized Placebo-controlled Clinical Trial to Evaluate the Effect of Perioperative Use of Tranexamic Acid on Transfusion Requirements and Surgical Bleeding in Major Spine Surgery	Phase 4
Completed	`NCT01191554` - Dose-ranging Study of Tranexamic Acid in Valve Surgery	N/A
Completed	`NCT01210417` - Trauma Heart to Arm Time	N/A
Completed	`NCT01085006` - The Effect of Tranexamic Acid on Postpartum Hemorrhage During and After Cesarean Delivery	Phase 1/Phase 2
Completed	`NCT00700141` - Non-Interventional Study About Treatment of Hemorrhages in Thyroid Surgery With TachoSil®	N/A
Completed	`NCT00375466` - Tranexamic Acid, Hemorrhage and Transfusions After Combined Aortic Valve Replacement and Coronary Artery Bypass Surgery.	N/A
Completed	`NCT00479362` - Anticoagulant Therapy During Pacemaker Implantation	Phase 4
Completed	`NCT00147420` - RCT of Zhi Byed 11 (ZB11) Versus Misoprostol in Tibet	N/A
Recruiting	`NCT05945680` - Tranexamic Acid in Breast Esthetic Surgery.	Phase 4
Completed	`NCT03273322` - Assessment of Dual Antiplatelet Therapy Versus Rivaroxaban In Atrial Fibrillation Patients Treated With Left Atrial Appendage Closure	Phase 2/Phase 3
Withdrawn	`NCT05672407` - The Role of Local Tranexamic Acid on Periorbital Oculoplastic Surgery	Phase 4