View Clinical Trial (Medical Research Study)
Effects of CoSeal in Reducing Perioperative Bleeding & Adhesions in Pediatric Heart Surgery
| City: |
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Loma Linda |
| State: |
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California |
| Zip Code: |
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92602 |
| Conditions: |
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Congenital Heart Defect - Surgery-Induced Tissue Adhesions - Hemorrhage |
| Purpose: |
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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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| Study Summary: |
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| Criteria: |
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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
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| NCT ID: |
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NCT01330433 |
| Primary Contact: |
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Principal Investigator
Nahidh Hasaniya, MD
Loma Linda University Medical Center
Megan Russell, MA
Phone: 909-558-4354
Email: merussell@llu.edu
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| Backup Contact: |
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Email: nhasaniya@llu.edu
Nahidh Hasaniya, MD
Phone: 909-558-4354
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| Location Contact: |
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Loma Linda, California 92602
United States
Megan ET Russell, MA
Phone: 909-558-4354
Email: merussell@llu.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2013 |
| Modifications to this listing: |
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