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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. The completion date has passed and the status has not been verified in more than two years.
Verified November 2006 by Soroka University Medical Center.
Recruitment status was:  Not yet recruiting
Information provided by:
Soroka University Medical Center Identifier:
First received: November 1, 2006
Last updated: November 2, 2006
Last verified: November 2006
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 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)

Resource links provided by NLM:

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


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • patients admited for coronary artery bypass surgery

Exclusion Criteria:


  • 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 CVA.
  • Postoperative critical condition precluding safe performance of OCT examination.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00395369

Contact: Dan Abramov, MD 97286400962

Soroka Medical Center Active, not recruiting
Beer Sheva, Israel, 84101
Sponsors and Collaborators
Soroka University Medical Center
Principal Investigator: Dan Abramov, MD Soroka University Medical Center
  More Information Identifier: NCT00395369     History of Changes
Other Study ID Numbers: SOR439106CTIL
Study First Received: November 1, 2006
Last Updated: November 2, 2006

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

Additional relevant MeSH terms:
Trypsin Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on September 19, 2017