Determination of the efficacy of EVICEL™ on blood loss in orthopaedic surgery after total knee replacement: study protocol for a randomised controlled trial

Table 1 Schedule of events

Procedures	Baseline (within 72 h prior to procedure)	Day of surgery	Postoperative stay in hospital	3 Months after surgery ± 2 weeks	6 Months after surgery ± 2 weeks	12 Months after surgery ± 2 weeks
Inclusion/exclusion	X	X
Randomisation		X
Informed consent	X
Demographics	X
Medical history	X
Concomitant medications including use of analgesics or peripheral nerve block	X	X	X^d	X	X	X
Physical examination (ROM)	X		X^d	X	X	X
Laboratory tests (virology^a, CBC^b, clinical chemistry^c)	X^a–c		X^e,b,c
Coagulation parameters (INR, PTT)	X
Treatment application		X
Intraoperative data assessment		X
Clinical outcome score assessment (KSS/KOOS)	X		X^f	X	X	X
Surgical site assessment			X^d	X	X	X
Wound healing assessment			X^d
Assessment of patient’s mobility on crutches (stairs)			X^d
Adverse events		X	X^d	X	X	X
Assessment of physiotherapy treatments after rehabilitation				X	X	X
Calculation of overall costs of TKR						X

^aVirology: Hep B/C and HIV screening
^bCBC: Hb, leucocytes
^cClinical chemistry: CRP
^dAssessment daily during the visits (except for Sundays as for the physical examination)
^eAssessment on days 2, 4 and 6 (+/− 1 day) and on day 7
^fAssessment on day 7

ISSN: 1745-6215