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. 2016 Dec 15;6(12):e012299. doi: 10.1136/bmjopen-2016-012299

Table 1.

Participant timeline

Day number in relation to surgery day −1 0 1 2 3 4 1 month telephone call
Informed consent X
Inclusion/exclusion criteria X X
Randomisation X
Study drug X
AE and SAE registration and report X X X X X X
Blood ciclosporin concentration X X
Blood tests efficacy: P-cystatin C, P-creatinine X X X X X
Analysis U-TIMP-2, U-IGFBP7, U-albumin/creatinine X X
Blood tests safety: Mg, K, urea, myoglobin, ASAT, ALAT, bilirubin, ALP, GT, leucocytes, CRP, CK, Hb, Trc X X X X X
Exploratory immunological tests X X
Blood tests cardiac: troponin T, CK MB X X X X X
Blood test cerebral: S-S100B X X X
Documentation of: hourly diuresis, bleeding at 12 hours and total, time to extubation, time in ICU, fluid balance X X
Temperature, blood pressure X X X X X
Scoring leg wound infection. X

Day 1 illustrates the day before surgery, usually the same as admission day, day 0 surgery day, day 1 the day after surgery, etc.

AE, adverse event; ALAT, alanine aminotransferase; ALP, alkaline phosphatase; ASAT, aspartate aminotransferase; CK, creatine kinase; CRP, C reactive protein; GT, γ-glutamyl transferase; Hb, haemoglobin; ICU, intensive care unit; IGFBP7, insulin-like growth factor binding protein 7; K, potassium; Mg, magnesium; SAE, serious adverse event; TIMP-2, tissue inhibitor of metalloproteinase 2; Trc, thrombocytes.