Consent to the corneal donation in Germany
- Conditions
- Corneal clouding, infections, cause of death
- Registration Number
- DRKS00016990
- Lead Sponsor
- Deutsche Gesellschaft für Gewebetransplantation Gemeinnützige Gesellschaft mbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 19000
All patients reported to the DGFG network who were older than 3 years of age at the time of the notification and who had a conversation about the possibility of corneal donation with relatives.
Contraindications are tissue specific. In addition, there are absolute contraindications. The following overview lists the most common absolute contraindications:
• viral infections: HIV, HBV, HCV, HTLV I / II, measles, rubella, VZV, meningitis / encephalitis, active systemic infections (bacterial: typhoid, borreliosis, syphilis, TBC, parasitic: e.g., malaria, toxoplasmosis)
• Sepsis with multidrug-resistant bacterial agents (MRSA, VISA, VRSA, ESBL) or fungal sepsis
• ever tumors of the hematopoietic system (myelodysplastic syndrome, leukemia, malignant lymphoma, plasmocytoma, polycythemia vera)
• recipient of cornea, sclera, dura mater
Central nervous system disease of unknown origin (e.g., Alzheimer's disease, Parkinson's disease, ALS, MS)
• risk of disease transmission by prions (persons with CJD or in the genetic family, with rapidly progressing dementia, recipients of human pituitary hormones)
• Long-term immunosuppressive
• unclear cause of death (except for planned autopsy)
• Individuals with unresolved infections from Zika virus areas
There are also tissue-specific contraindications for ophthalmological tissue:
• Serious local infections of the eye
• Malignant tumor of the fundus, retinoblastoma
• corneal diseases
The assessment of the donation is carried out by a doctor of the DGFG. Among other things, the information is collected
• The current and historical medical records of the donor
• the questioning of the treating physicians or the family doctor of the deceased
• the questioning of a person who knew the donor well
• the autopsy report
Age limits cornea
Corneal donors must be at least 3 years old, there is no upper age limit for the donation of ophthalmic tissue (eye). Tissue extraction is therefore possible even in old age. However, the upper limit of the DGFG is 90 years in accordance with the requirements of the transplant facilities.
infectious Diseases
Only donors who have blood for a valid diagnosis (HBsAg, anti-HBc, anti-HCV, anti-HIV1 / 2, lues TPHA, HBV / HCV / HIV multiplex (RT) -PCR) are eligible , If no sample is available, a blood sample can be taken within 24 hours after death. In the case of organ donations, the blood is taken at the latest before the beginning of the perfusion. The blood or plasma dilution must not exceed 50 percent.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Consent rate and the factors influencing the consent of a tissue donation
- Secondary Outcome Measures
Name Time Method