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Consent to the corneal donation in Germany

Consent to the corneal donation in Germany

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00016990
Enrollment
19000
Registered
2019-04-16
Start date
2019-04-22
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corneal clouding, infections, cause of death

Interventions

Group 1: The aim of the proposed study is to determine retrospectively in a pseudoanonymized study cohort of the DGFG conducted discussions from September 2013 to February 2018 the approval rates, to

Sponsors

Deutsche Gesellschaft für Gewebetransplantation Gemeinnützige Gesellschaft mbH
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 95 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Consent rate and the factors influencing the consent of a tissue donation

Countries

Germany

Contacts

Public ContactStephan Sixt

Deutsche Gesellschaft für Gewebetransplantation Gemeinnützige Gesellschaft mbH

stephan.sixt@gewebenetzwerk.de+49 511 563 559 30

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026