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Table 1 Flowchart

From: Comparison of 6 % hydroxyethyl starch and 5 % albumin for volume replacement therapy in patients undergoing cystectomy (CHART): study protocol for a randomized controlled trial

Schedule of activities Visit 1 Visit 2 Visit 3 Visit 4 Visit 5
Screening day (day −1) Day 0 (day of surgery) Day 1 Day 3 Day 90
Informed consent X     
Inclusion and exclusion criteria X     
Demographic data X     
Medical history (primary diagnosis) X     
Pregnancy test for women of childbearing potential X     
Mini Mental State Examination X     
Life Quality Assessment (ADL, IADL) X     X
Concomitant medications (diuretics) X X X X X
Cystatin C, GFR, serum creatinine X X X X X
ROTEM, Multiplate, PFA 100   X    
Randomization   X    
NGAL, syndecan 1, hyaluronan   X X X  
Study drug   X X X  
Blood products   X X X  
IV fluid amount   X X X  
Blood losses and urine output   X X X  
Nursing Delirium Screening Scale   X X X  
AEs and SAEs   X X X X
Pruritus assessment      X
  1. ADL activities of daily living, AE adverse event, IADL instrumental activities of daily living, IV intravenous, NGAL neutrophil gelatinase-associated lipocalin, PFA 100 Platelet Function Analyzer 100, ROTEM rotational thrombelastometry, SAE serious adverse event2