Table 3 Efficacy and safety endpoint evaluation timetable
From: Vitamin D for prevention of sternotomy healing complications: REINFORCE-D trial
Week | Examination of the subject by the investigator | Laboratory examination of the subject | Evaluation of subject’s quality of life | Imaging examination of the subject |
|---|---|---|---|---|
0 | Initial interview with the patient + initial medical examination + decision to offer clinical trial participation to the patient | Initial complete biochemical examination including monitored parameters (calcium, phosphate, calcidiol, and ALP) | Acquaintance with the trial + provision of signed informed consent | |
1 | Continuous determination of several biochemical parameters during hospitalization: serum calcium (minimally every other day), ALP values (minimally once during hospitalization), and serum phosphate (minimally once during hospitalization) | |||
2 | Examination of the surgical wound before hospital discharge | Laboratory tests before discharge | ||
6 | Continuous examination of surgical wound | Continuous evaluation of serum calcium, ALP, and phosphate | ||
26 | Exit examination of the surgical wound | (1) Final lab. test of serum calcium, ALP, and phosphate; (2) calcidiol level; (3) doctor’s entry in Questionnaire No. 1 | Final evaluation of quality of life according to Questionnaire No. 2 | Computed tomography of the chest |