Effect of Intraoperative Aprotinin Administration on Post Cardiac Surgery Optic Nerve and Retinal Thickness. - Full Text View

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

This study is not yet open for participant recruitment.
Verified by Soroka University Medical Center, November 2006

Sponsored by:	Soroka University Medical Center
Information provided by:	Soroka University Medical Center
ClinicalTrials.gov Identifier:	NCT00395369

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

MedlinePlus related topics:

CT Scans

ChemIDplus related topics:

Aprotinin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Placebo Control, Single Group Assignment, Efficacy Study

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

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

Keywords provided by Soroka University Medical Center:

aprotinin

cardiac surgery

neurological dysfunction

optical coherance tomography

Study placed in the following topic categories:

Aprotinin

Additional relevant MeSH terms:

Serine Proteinase Inhibitors

Coagulants

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Hematologic Agents

Trypsin Inhibitors

Enzyme Inhibitors

Hemostatics

Pharmacologic Actions

Protease Inhibitors

ClinicalTrials.gov processed this record on September 23, 2008