Trial document




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  DRKS00016990

Trial Description

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Title

Consent to the corneal donation in Germany

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The corneal donation in Germany is an essential part of treatment for patients with perforating eye injuries and corneal opacities. With around 5000 transplanted corneas a year, this procedure is by far one of the most common transplants in Germany. Almost 3,700 patients received a tissue transplant from the network of the German Society for Tissue Transplantation (DGFG) in 2018 for this purpose. Unlike organ donation, tissue donation in Germany is also possible after cardiac arrest. For this purpose, deceased patients are reported to the DGFG and first of all the medical suitability is checked by trained personnel and physicians. After evaluation of the patient's file and exclusion of the relevant contraindications, relatives and carers will be contacted to obtain consent for the corneal donation.
So far, there are only a few data on interviewing, the consent rate and the factors influencing the consent of tissue donation.

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Brief Summary in Scientific Language

The aim of the proposed study is to retrospectively determine approval rates in a pseudoanonymized study cohort of the DGFG's discussion of 2012-2018, to determine independent influencing factors of consent and to determine seasons and regional differences in Germany.

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Organizational Data

  •   DRKS00016990
  •   2019/04/16
  •   [---]*
  •   yes
  •   Approved
  •   8407_BO_K_2019, Ethikkommission der Medizinischen Hochschule Hannover
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Secondary IDs

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Health Condition or Problem studied

  •   Corneal clouding, infections, cause of death
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Interventions/Observational Groups

  •   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 determine independent, (non) modifiable influencing factors on the approval, as well as to represent seasonal and regional differences in Germany
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Blinded
  •   patient/subject
  •   Other
  •   Health care system
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

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

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2019/04/22
  •   19000
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   3   Years
  •   95   Years
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Additional 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.

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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.

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Addresses

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    • Deutsche Gesellschaft für Gewebetransplantation Gemeinnützige Gesellschaft mbH
    • Feodor-Lynen-Str. 21
    • 30625  Hannover
    • Germany
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    • Deutsche Gesellschaft für Gewebetransplantation Gemeinnützige Gesellschaft mbH
    • Mr.  PD.Dr.med  Stephan  Sixt 
    • Feodor-Lynen-Str. 21
    • 30625  Hannover
    • Germany
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    • Deutsche Gesellschaft für Gewebetransplantation Gemeinnützige Gesellschaft mbH
    • Mr.  PD.Dr.med  Stephan  Sixt 
    • Feodor-Lynen-Str. 21
    • 30625  Hannover
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Gesellschaft für Gewebetransplantation Gemeinnützige Gesellschaft mbH
    • Feodor-Lynen-Str. 21
    • 30625  Hannover
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.