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

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ClinicalTrials.gov 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
Sponsor:
Information provided by:
Soroka University Medical Center

Study Description
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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 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 or disease Intervention/treatment Phase
Cardiac Surgery Drug: intraoperative aprotinin administration Not Applicable

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Study Design
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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
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. optical coherance tomography findings

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00395369     History of Changes
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:
aprotinin
cardiac surgery
neurological dysfunction
optical coherance tomography

Additional relevant MeSH terms:
Aprotinin
Hemostatics
Coagulants
Trypsin Inhibitors
 Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action