Effects of ulinastatin therapy in deep vein thrombosis prevention after brain tumor surgery: A single-center randomized controlled trial

Table 1 Comparison of baseline data, n (%)

	UTI group (n = 180)	Placebo group (n = 181)	P value
Age (yr, mean ± SD)	58.7 ± 4.2	59.1 ± 4.3	0.372
Gender			0.881
Male	109 (60.56)	111 (61.33)
Female	71 (39.44)	70 (38.67)
BMI (kg/cm2, mean ± SD)	22.1 ± 2.1	22.5 ± 2.4	0.090
Smoking history			0.561
Yes	73 (40.56)	68 (37.57)
No	107 (59.44)	113 (62.43)
Living environment			0.393
Town	126 (70.00)	134 (74.03)
Countryside	54 (30.00)	47 (25.97)
Past medical history
Hypertension	65 (36.11)	60 (33.15)	0.554
Hyperlipidemia	76 (42.22)	69 (38.12)	0.427
Diabetes	59 (32.78)	52 (28.73)	0.405
Cholelithiasis	31 (17.22)	35 (19.34)	0.603
Brain tumor type			0.355
Benign tumor	114 (63.33)	123 (67.96)
Malignant tumor	66 (36.67)	58 (32.04)
Surgery time (h, mean ± SD)	4.6 ± 1.5	4.4 ± 1.4	0.191

BMI: Body mass index; UTI: Ulinastatin.

Table 2 Comparison of baseline data between two venous thromboembolism group patients, n (%)

VTE Patients	UTI group (n = 15)	Placebo group (n = 28)	P value
Age (yr, mean ± SD)	59.9 ± 8.1	59.4 ± 8.5	0.853
Gender			0.782
Male	9 (60.00)	18 (64.29)
Female	6 (40.00)	10 (35.71)
BMI (kg/cm2, mean ± SD)	22.4 ± 2.5	22.1 ± 2.4	0.702
Smoking History			0.598
Yes	10 (66.67)	19 (67.86)
No	5 (33.33)	9 (32.14)
Living environment			0.702
Town	13 (72.22)	23 (82.14)
Countryside	2 (27.78)	5 (17.86)
Past medical history
Hypertension	8 (53.33)	15 (53.57)	0.988
Hyperlipidemia	8 (53.33)	12 (42.86)	0.512
Diabetes	7 (46.67)	13 (46.43)	0.988
Cholelithiasis	6 (40.00)	10 (35.71)	0.782
Brain tumor type			0.484
Benign tumor	8 (53.33)	18 (64.29)
Malignant tumor	7 (46.67)	10 (35.71)
Surgery time (h, mean ± SD)	4.7 ± 1.7	4.6 ± 1.5	0.843

BMI: Body mass index; UTI: Ulinastatin; VTE: Venous thromboembolism.

Table 3 Comparison of the secondary end-points

	UTI (n = 180)	Placebo (n = 181)	P value
Coagulation function, mean ± SD
PT (s)	9.25 ± 2.27	15.36 ± 2.81	< 0.001
APTT (s)	21.13 ± 3.28	26.22 ± 3.29	< 0.001
D-D (mg/L)	1.84 ± 0.72	2.41 ± 0.92	< 0.001
FIB (g/L)	2.71 ± 0.49	2.89 ± 0.58	0.002
Pulmonary embolism	3 (1.67%)	1 (0.55%)
Liver function index levels, mean ± SD
ALT (U/L)	39.27 ± 4.16	41.29 ± 4.25	< 0.001
AST (U/L)	28.84 ± 3.26	29.48 ± 3.87	0.09
Renal function index levels, mean ± SD
Scr	54.33 ± 8.21	56.08 ± 9.42	0.06
BUN	6.37 ± 2.95	8.11 ± 3.10	< 0.001

APTT: Activated partial thromboplastin time; ALT: Alanine aminotransferase; AST: Aspartate aminotransferase; BUN: Blood urea nitrogen; D-D: D-Dimer; FIB: Fibrinogen; PT: Prothrombin time; Scr: Serum creatinine.

Table 4 Comparison of safety evaluation, and postoperative hospital stays and costs, n (%)

	UTI (n = 180)	Placebo (n = 181)	P value
Granulocytopenia	17 (9.44)	14 (7.73)	0.562
Abnormal liver enzymes	16 (8.88)	11 (6.08)	0.310
Diarrhea	44 (24.44)	31 (17.12)	0.087
Vomiting	34 (18.88)	22 (12.15)	0.077
Allergies	29 (16.11)	15 (8.29)	0.023
Hospitalization stays, day, mean ± SD	13.46 ± 4.56	14.13 ± 4.79	0.174
Hospitalization costs, CNY×104, mean ± SD	5.27 ± 2.28	5.12 ± 2.09	0.515

UTI: Ulinastatin; CNY: ChinaYuan.