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

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 Intervention Model: Single Group Assignment Masking: None (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


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

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 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


ClinicalTrials.gov 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:


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

ClinicalTrials.gov processed this record on September 19, 2017

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