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Table 2 Schedule of study related activities and data collection.

From: A therapeutic exploratory study to determine the efficacy and safety of calcineurin-inhibitor-free de-novo immunosuppression after liver transplantation: CILT

Study activity

Day

Month

 

-3-0

1

2

3

5

10

14/15

20/21

25/26

30

3

6

12

Patient baseline characteristics and transplant data

Informed consent

*

            

Medical history

*

            

Physical examin

*

            

Graft history

*

            

Pregnancy test

*

            

Safety parameters

Vital signs

*

*

*

*

*

*

*

*

*

*

*

*

*

Blood chemistry†

*

*

*

*

*

*

*

*

*

*

*

*

*

Heamogram

*

*

*

*

*

*

*

*

*

*

*

*

*

Coagulation lab†

*

*

*

*

*

*

*

*

*

*

*

*

*

MPAtrough level

 

*

*

*

*

*

*

*

*

*

*

*

*

EVL trough level

      

*

*

*

*

*

*

*

Ultrasound‡

 

*

*

*

 

*

       

Adverse events

 

*

*

*

*

*

*

*

*

*

*

*

*

Rejection¶

 

*

*

*

*

*

*

*

*

*

*

*

*

Efficacy parameters

eGFR

*

*

*

*

*

*

*

*

*

*

*

*

*

Rejection||

 

*

*

*

*

*

*

*

*

*

*

*

*

  1. The chart indicates mandatory measurements and/or recordings by an asterisk (green background color). Blood samples already taken in the routine process at the planned time do not have to be taken twice.
  2. † Mandatory laboratory measurements include: sodium, potassium, creatinine, urea, alanine transaminase, aspartate transaminase, alkaline phosphatase, γ-glutamyl transferase, total bilirubin, lactate dehydrogenase, cholesterole, triglycerides, activated partial thromboplastine time and Quick's value.
  3. ‡ Additional examinations in case of pathological findings or indication.
  4. ¶ If laboratory measurements and/or clinical data indicate rejection the attending transplant surgeon may decide to begin treatment with steroids. If the rejection is clinically resistant to therapy with steroids a liver biopsy has to be obtained. Only if there is histological evidence for steroid resistant rejection it will be classified as such.
  5. || Rejection is a safety and efficacy parameter.