Effect of Intraoperative Aprotinin Administration on Post Cardiac Surgery Optic Nerve and Retinal Thickness.
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2006 by Soroka University Medical Center.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Soroka University Medical Center
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
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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 Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
| 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
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
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 |
| Health Authority: | Israel: Ministry of Health |
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 28, 2016