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Home > Special Studies > Study Design

Study Design

I. Serum collection for "Pretransplant Serum Study":

• One pretransplant serum, preferably last serum before transplantation

II. Serum collection for "Posttransplant Serum Study":

• Pretransplant serum, preferably last serum before transplantation
• 2 sera during the first posttransplant week, preferably on days 2 and 6
• 1 serum at the end of the 1st posttransplant month
• Not obligatory - but if possible - additional sera at the end of month 3, 6, 12, and 24, obtained during routine clinical visits

Serum Collection Scheme
Pre-Tx	First Post-Tx Week	One Month	Additional Sera
Day 0	Days 2, 6	Day 30	approx. Days 90, 180, 365, 730

Samples:

1-2 ml serum without additives (minimum 0.5 ml). Two hours after blood donation, the serum should be separated from cell material by centrifugation and frozen and stored at -20°C. Shipment of frozen samples to Heidelberg, Germany, at dates to be announced (twice a year).

Documentation:

• Regular CTS questionnaires (no additional paper work)
• One additional 3-month questionnaire:   ( Download study form )
  • Graft function within 24 hours:  Yes / No
  • Rejection during first 3 months:  Yes / No
    • If yes: Date first rejection diagnosed: ... (Day/Month/Year)
    • If yes: Banff-97 Grading (if available): ...
  • Acute Tubular Necrosis (ATN):  Yes / No
    • If yes: Was patient dialyzed?  Yes / No
  • Calcineurin inhibitor-induced nephrotoxicity:  Yes / No
  • Infection during the first week:  Yes (viral, bacterial, fungal) / No