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Effect of Intraoperative Aprotinin Administration on Post Cardiac Surgery Optic Nerve and Retinal Thickness.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2006 by Soroka University Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT00395369
First received: November 1, 2006
Last updated: November 2, 2006
Last verified: November 2006
History of Changes
  Purpose

Cognitive and neurological dysfunction after coronary artery bypass surgery (CABG) is common and multi-factorial in origin. Several previous studies have shown that intraoperative aprotinin administration may be neuroprotective.in the current prospective randomized study, the effect of intraoperative aprotinin administration on the integrity of the optic nerve and retinal nerve fiber layer will be examined. Optical coherance tomography will be used to examin the optic nerve and retinal nerve fiber layer.


Condition Intervention
Cardiac Surgery
 Drug: intraoperative aprotinin administration

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label

Resource links provided by NLM:

MedlinePlus related topics: Heart Surgery
Drug Information available for: Aprotinin
U.S. FDA Resources

Further study details as provided by Soroka University Medical Center:

Primary Outcome Measures:
  • optical coherance tomography findings

Estimated Enrollment: 30
Study Start Date: December 2007
  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients admited for coronary artery bypass surgery

Exclusion Criteria:

Preoperative:

  • Patients requiring concomitant noncoronary procedures.
  • Urgent operation.
  • Intra aortic balloon pump
  • Presence of allergy to aprotinin or bleeding diathesis.
  • Previous CVA.
  • Previous eye operation.
  • Glaucoma.
  • Retinopathy.

Postoperative:

  • Postoperative CVA.
  • Postoperative critical condition precluding safe performance of OCT examination.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00395369

Contacts
Contact: Dan Abramov, MD 97286400962 danab3@clalit.org.il

Locations
Israel
Soroka Medical Center Active, not recruiting
Beer Sheva, Israel, 84101
Sponsors and Collaborators
Soroka University Medical Center
Investigators
Principal Investigator: Dan Abramov, MD Soroka University Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00395369     History of Changes
Other Study ID Numbers: SOR439106CTIL
Study First Received: November 1, 2006
Last Updated: November 2, 2006
Health Authority: Israel: Ministry of Health

Keywords provided by Soroka University Medical Center:
aprotinin
cardiac surgery
neurological dysfunction
optical coherance tomography

Additional relevant MeSH terms:
Aprotinin
Trypsin Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013