NCT00395369

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2006

Completed
1.1 years until next milestone

Study Start

First participant enrolled

December 1, 2007

Completed
Last Updated

November 3, 2006

Status Verified

November 1, 2006

First QC Date

November 1, 2006

Last Update Submit

November 2, 2006

Conditions

Cardiac Surgery

Keywords

aprotinincardiac surgeryneurological dysfunctionoptical coherance tomography

Outcome Measures

Primary Outcomes (1)

  • optical coherance tomography findings

Interventions

intraoperative aprotinin administrationDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients admited for coronary artery bypass surgery

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soroka Medical Center

Beersheba, 84101, Israel

Location

Study Officials

  • Dan Abramov, MD

    Soroka University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dan Abramov, MD

CONTACT

97286400962danab3@clalit.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 2006

First Posted

November 2, 2006

Study Start

December 1, 2007

Last Updated

November 3, 2006

Record last verified: 2006-11

Locations

IL(1)