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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00395369
Recruitment Status : Unknown
Verified November 2006 by Soroka University Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : November 2, 2006
Last Update Posted : November 3, 2006
Information provided by:
Soroka University Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Cardiac Surgery Drug: intraoperative aprotinin administration Not Applicable

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Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Study Start Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery
Drug Information available for: Aprotinin

Primary Outcome Measures :
  1. optical coherance tomography findings

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00395369

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Contact: Dan Abramov, MD 97286400962

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Soroka Medical Center
Beer Sheva, Israel, 84101
Sponsors and Collaborators
Soroka University Medical Center
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Principal Investigator: Dan Abramov, MD Soroka University Medical Center
Layout table for additonal information Identifier: NCT00395369    
Other Study ID Numbers: SOR439106CTIL
First Posted: November 2, 2006    Key Record Dates
Last Update Posted: November 3, 2006
Last Verified: November 2006
Keywords provided by Soroka University Medical Center:
cardiac surgery
neurological dysfunction
optical coherance tomography
Additional relevant MeSH terms:
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Trypsin Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action