Table 1

Clinical trial schedule

Timepoint	Study period
	Screening	Allocation	Postallocation		Hospital discharge	Follow-up	Premature termination
	D₀	D_0–1	D₁	D₂	D_3–28	D₂₈	Anytime
Enrolment
Inclusion/Exclusion criteria	X
Informed consent	X
Pregnancy testing*	X
Randomisation		X
Intervention
Study medication application†			X
Assessments
Demographic data‡	X
Adverse events			X	X	X	X	X
Laboratory testing§			X	X
Blood loss¶			X	X
Urinary output**			X	X
Transfusion products consumption††			X	X
Fluid therapy††			X	X
ICU LOS (days)					X
LOS (days)					X
28-day mortality						X
Reason for premature termination							X

*Urine pregnancy testing.
†Fibrinogen infusion or standard of care.
‡Age, sex, weight, Cobb’s angle.
§Haemoglobin, haematocrit, platelet count, fibrinogen, aPTT, PT, TT.
¶Volume (mL) during surgery and in the 24-hour postoperative period and volume (mL) related to the surgical segment of the spine.
**Volume (mL) in the 24-hour postoperative period.
††Type and volume (mL) during surgery and in the 24-hour postoperative period.
aPTT, activated partial thrombin time; ICU, intensive care unit; LOS, length of stay; PT, prothrombin time; TT, thrombin time.