. 2021 Apr 1;4(4):e213936. doi: 10.1001/jamanetworkopen.2021.3936

Table 2. Details of Intervention, Laboratory Values, Bleeding Severity, and Hemostatic Therapies.

Variable	PCC group (n = 54)	FP group (n = 47)	P value
Intervention details
Dosage of investigational product
Mean (SD)	25.9 (8.7) IU/kg	12.5 (7.4) mL/kg	Not applicable
Median (IQR)	24.9 (21.8-27.0) IU/kg	12.5 (10.0-15.0) mL/kg
Doses of investigational product, No. (%)			.25^a
1	49 (90.7)	38 (80.9)
2	5 (9.3)	9 (19.1)
Time from start of surgery to order of first dose, median (IQR), h	5.2 (4.2-5.9)	5.0 (4.3-5.4)	.29^b
Time from end of CPB to administration of first dose, median (IQR), h	1.0 (0.5-1.5)	1.2 (0.8-1.5)	.19^b
Time from administration of first dose to leaving the operating room, h^c			.83^b
No.	51	43
Median (IQR)	1.1 (0.7-1.6)	1.2 (0.7-1.9)
Laboratory values
Hemoglobin, g/dL
Intraoperative nadir			.18^d
No.	54	47
Mean (SD)	8.3 (1.4)	7.9 (1.3)
Intraoperative post-CPB			.20^d
No.	54	46
Mean (SD)	10.0 (1.3)	9.7 (1.3)
Day of surgery (last recorded value)			<.001^d
No.	53	47
Mean (SD)	10.7 (1.6)	9.5 (1.3)
Postoperative day 1 (last recorded value)			.33^d
No.	53	47
Mean (SD)	9.4 (1.4)	9.1 (1.2)
Platelet count, ×10³/µL
Intraoperative post-CPB			.29^d
No.	53	43
Mean (SD)	116 (36)	125 (43)
Day of surgery (last recorded value)			.09^d
No.	52	47
Mean (SD)	168 (51)	152 (42)
Postoperative day 1 (last recorded value)			.63^d
No.	53	47
Mean (SD)	153 (56)	148 (52)
International normalized ratio
Intraoperative, post-CPB			.83^d
No.	53	44
Mean (SD)	2.3 (1.4)	2.2 (0.9)
Day of surgery (last recorded value)			.11^d
No.	50	46
Mean (SD)	1.3 (0.3)	1.4 (0.2)
Postoperative day 1 (last recorded value)			.81^d
No.	53	46
Mean (SD)	1.2 (0.3)	1.3 (0.2)
Fibrinogen, mg/dL
Intraoperative post-CPB			.36^d
No.	51	45
Mean (SD)	200 (60)	210 (70)
Bleeding severity and hemostatic therapies
Postintervention hemostatic therapy from 60 min to 4 h, No. (%)^e
No	43 (79.6)	32 (68.1)	.25^a
Yes	11 (20.4)	15 (31.9)	.25^a
Postintervention hemostatic therapy from 60 min to 24 h, No. (%)^e
No	41 (75.9)	31 (66.0)	.28^a
Yes	13 (24.1)	16 (34.0)	.28^a
Bleeding categories according to modified UDPB classification^f
Moderate (class 2), No. (%)	42 (79.2)	29 (61.7)	.08^a
Severe or massive (classes 3 and 4), No. (%)	11 (20.8)	18 (38.3)	.08^a
Chest tube drainage, mL
12 h			<.001^b
No.	53
Median (IQR)	310 (250-455)	500 (310-750)
24 h			<.001^b
No.	53
Median (IQR)	450 (370-630)	700 (470-950)
Reexploration, No. (%)	3 (5.6)	5 (10.6)	.47^a
Fibrinogen concentrate, No. (%)	23 (42.6)	22 (46.8)	.69^a
Recombinant factor VII, No. (%)	1 (1.9)	3 (6.4)	.34^a

Abbreviations: CPB, cardiopulmonary bypass; FP, frozen plasma; IQR, interquartile range; PCC, prothrombin complex concentrate; UDPB, universal definition of perioperative bleeding.

SI conversion factors: To convert hemoglobin to grams per liter, multiply by 10.0; platelet count to ×10⁹/L, by 1.0; and fibrinogen to grams per liter, by 0.01.

^{^a}

Based on results of the Fisher exact test.

^{^b}

Based on results of the Wilcoxon signed rank test.

^{^c}

Excluding patients who were randomized in the operating room but received interventional product after leaving the operating room.

^{^d}

Based on results of the t test.

^{^e}

Includes receipt of any allogeneic blood transfusions, hemostatic adjuncts, or procedures from 60 minutes to 4 hours and from 60 minutes to 24 hours after intervention initiation.

^{^f}

Determinants used in this study included postoperative chest tube output; units of red blood cells, plasma, and platelets transfused; use of factor concentrates; and surgical reexploration.²¹ For this study the following components of the UDPB score were not used: delay in chest closure and use of cryoprecipitate. Because all patients received PCC or FP, none are classified as lower than 2. Data missing from 1 patient who died in the PCC group.