A French multicenter randomised trial comparing two dose-regimens of prothrombin complex concentrates in urgent anticoagulation reversal

Table 2 Overall clinical outcome at 48 hours and day 30 after infusion, in 25 and 40 IU/kg groups.

	4-factor PCC regimen
	25 IU/kg (n = 29)	40 IU/kg (n = 30)	P value
Overall clinical response - verbal rating scale at 48 h			1.000
None	2 (8.0)	2 (7.1)
Moderate	6 (24.0)	7 (25.0)
Excellent	17 (68.0)	19 (67.9)
GCS
At 48 hours	13.1 ± 3.8	13.1 ± 3.8	0.724
At day 30	12.8 ± 4.0	13.3 ± 3.2	0.858
GOS-E at day 30*			0.460
Dead	2 (7.7)	4 (14.3)
Vegetative state	2 (7.7)	1 (3.6)
Lower severe disability	10 (38.5)	11 (39.3)
Upper severe disability	2 (7.7)	4 (14.3)
Lower moderate disability	1 (3.8)	1 (3.6)
Lower good recovery	2 (7.7)	5 (17.9)
Upper good recovery	7 (26.9)	2 (7.1)
mRS at day 30	3.0 ± 2.0	3.4 ± 2.0	0.342
BI at day 30	53.4 ± 40.2	46.0 ± 43.2	0.623

Results are expressed as n (%) or mean ± SD. *GOS-E was performed for a total of 54 patients: 26 patients in the 25 IU/kg group and 28 patients in the 40 IU/kg group, which explains the difference in number of deaths with that reported in the text (n = 10). BI, Barthel Index; GCS, Glasgow Coma Scale; mRS, modified Rankin Scale; GOS-E, extended Glasgow Outcome Scale; PCC, prothrombin complex concentrate.

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