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Sponsors and Collaborators: |
University Hospital Freiburg German Research Foundation |
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Information provided by: | University Hospital Freiburg |
ClinicalTrials.gov Identifier: | NCT00810472 |
Penetrating keratoplasty is one of the most commonly performed transplantation surgeries. Graft rejection is a major complication. HLA compatibility has already been demonstrated an effective prophylaxis in several retrospective investigations. The purpose of the investigators randomized clinical trial is to demonstrate superiority of HLA matching in comparison to random graft assignment with respect to the endpoint 'time to first endothelial graft rejection' in penetrating keratoplasty. The investigators will perform DNA-based allele resolution typing.
Condition | Intervention |
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Corneal Diseases |
Other: HLA Matching Procedure: Penetrating keratoplasty |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Clinical Trial to Investigate Superiority of HLA Matching in Comparison to Random Graft Assignment With Respect to the Endpoint 'Time to First Endothelial Graft Rejection' in Penetrating Keratoplasty. |
Estimated Enrollment: | 650 |
Study Start Date: | August 2009 |
Estimated Study Completion Date: | April 2012 |
Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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HLA Matching: Experimental
HLA matching is exerted by selecting the donor with least-most additional HLA alleles. We will predict the waiting time for such a donor in order to assess eligibility for the trial [8]. In addition, we will dynamically adopt the degree of matching that is aimed at depending on the predicted time interval and actual waiting time: the first donors not exerting more than 7 mismatches at the triplet-amino-acid-residue-level (HLAMatchmaker method [6]) is accepted if the patient is waiting less than half of his predicted waiting time. The next available donor exerting a 2/6 match (or better) is assigned thereafter. The next graft will be assigned, regardless of HLA matching after 6 months. |
Other: HLA Matching
HLA matching is exerted by selecting the donor with least-most additional HLA alleles. We will predict the waiting time for such a donor in order to assess eligibility for the trial [8]. In addition, we will dynamically adopt the degree of matching that is aimed at depending on the predicted time interval and actual waiting time: the first donors not exerting more than 7 mismatches at the triplet-amino-acid-residue-level (HLAMatchmaker method [6]) is accepted if the patient is waiting less than half of his predicted waiting time. The next available donor exerting a 2/6 match (or better) is assigned thereafter. The next graft will be assigned, regardless of HLA matching after 6 months.
Corneal transplantation.
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Random graft assignment: Placebo Comparator |
Procedure: Penetrating keratoplasty
Corneal transplantation.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Daniel Böhringer, MD | +49 761 270 4001 | daniel.boehringer@uniklinik-freiburg.de |
Contact: Daniela Goos, MD | +49 761 270 4001 | daniela.goos@uniklinik-freiburg.de |
Germany, Baden-Württemberg | |
University Eye Hospital Freiburg | |
Freiburg, Baden-Württemberg, Germany, 79106 |
Responsible Party: | University Eye Hospital Freiburg ( Daniel Böhringer ) |
Study ID Numbers: | FR-2008-FANCY |
Study First Received: | December 17, 2008 |
Last Updated: | July 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00810472 History of Changes |
Health Authority: | Germany: Ethics Commission |
Penetrating keratoplasty HLA matching Corneal diseases that require penetrating keratoplasty |
Corneal Diseases Eye Diseases |
Corneal Diseases Eye Diseases |