Thromboelastographic reference ranges for a cirrhotic patient population undergoing liver transplantation

Table 1 Demographic and laboratory data of the Patient Population and their indication for liver transplantation

	Study group (n = 261)
Males/females (n/n), %	(193/68) 73.9%/26.1%
Age (yr)	53.5 ± 9.4
Body mass index (kg/m2)	26.18 ± 6.40
MELD score	24 ± 6.5
Indication for liver transplantation (n, %)
Alcoholism	40 (15.3 %)
Viral	189 (72.4%)
Colestatic	15 (5.7%)
Other	17 (6.5 %)
HCC	107 (41 %)
Laboratory data
Hb (g/dL)	11.3 ± 2.2 (nv:12-16)
Hct (%)	3.4 ± 6.2 (nv: 36-46)
PLT (103/μL)	83.2 ± 66.7 (nv: 150-450)
PT (%)	53.6 ± 22.4 (nv: 70-100)
INR	1.7 ± 0.7 (nv: 0.84-1.24)
aPTT ratio	2.0 ± 9.3 (nv: 0.82-1.24)
Fibrinogen (mg/dL)	190 ± 120 (nv: 200-400)
ATIII (%)	50 ± 27(nv: 80-120)

Data are expressed as the median ± SD. MELD: Model for end stage liver disease; HCC: Hepatocellular carcinoma; PLT: Platelets; PT: Prothrombin time; INR: International normalized ratio; nv: Normal values.

Table 2 Medians, means, ranges and reference ranges (2.5%-97.5% percentiles) for thromboelastographic variables obtained from the study population (261 cirrhotic patients) and from the 40 healthy patients

	r (min)	k (min)	α(degree)	MA (mm)	A(30) mm	A(60) mm	Ly30 (%)	Ly60 (%)
Cirrhotic patient population (n = 261)
Reference values	6.2-58.5	4.2-39.2	3.4-42.8	10.4-63.5	9.8-62	92-62	0-4	0-10
Mean ± SD	23.7 ± 12.5	14.9 ± 9.6	18.2 ± 10	35.3 ± 12.8	33.8 ± 12.8	32.3 ± 12.6	0.38 ± 1	2.28 ± 4.3
Median (range)	21.8 (2.2/75.4)	12.3 (1.6/68.1)	16.1 (1.7/67)	33.6 (2.2/71.9)	33 (2/86)	31 (2.2/85.5)	0.0 (0/11)	0.40 (0/44)
Healthy population (n = 40)
Reference values	11-26	3-14	15-46	43-64	41-64	42-63	0-4	0-5
Mean ± SD	19.6 ± 1.3	9.8 ± 0.9	20.6 ± 1.2	43.7 ± 2.9	43.2 ± 3.1	42.9 ± 0.8	0.8 ± 2.5	0.9 ± 2.1
Median (range)	17.8 (8-27)	7.2 (2-15)	18.1 (13-48)	41.5 (41-66)	42 (39-67)	41.7 (41-65)	0.7 (0-5)	0.76 (0-7)
1P	0.039	< 0.001	0.131	< 0.001	< 0.001	< 0 .001	0.06	0.038
Number of tests below normal	25 (9.5%)	2 (0.76%)	112 (42.9%)	200 (77%)	192 (74%)	207 (79%)	0	0
Number of tests above normal	84 (32%)	125 (47.9%)	2 (0.8%)	6 (2.3%)	5 (1.9%)	5 (1.9%)	2 (0.76%)	28 (10.7%)
Total number of tests outside the healthy population range	109 (41.5%)	127 (48.6%)	114 (43.7%)	206 (79.3%)	197 (74.4%)	212 (80.9%)	2 (0.76%)	28 (10.7%)

Number of test results outside the normal reference range proposed by the manufacturer. r: Time to initial fibrin formation; k: Time to clot formation; α: Alpha angle, rate of clot formation; MA: Maximum amplitude, absolute clot strength; A30: Maximum amplitude at 30 min after MA; Ly30: Fibrinolysis at 30 min after MA; Ly60: Fibrinolysis at 60 min after MA;

¹P value expresses the significant differences between the mean values obtained from the study population and from the healthy population.

Table 3 Median and reference ranges for thromboelastography assay in the study population according to gender, age, model for end-stage liver disease, liver disease and presence of hepatocellular carcinoma

	r (min)	k (min)	α(degree)	MA (mm)	A (30) mm	A (60) mm	Ly30 (%)	Ly60 (%)
Females (n = 68)	22.7 (7.6-58.6)	12.5 (3-38.5)	16.5 (4.1-52.2)	38.1 (10.3-70)	37.7 (8.5-71.1)	35.5 (6.7-71.1)	0.0 (0-4)	0.25 (0-26.5)
Males (n = 193)	22.8 (5.8-61.5)	13.5 (3.2-44.9)	15.8 (3.9-49.8)	34 (8.1-71.2)	33.4 (8.1-75)	3.3 (6.7-75)	0.0 (0-4)	0.4 (0-10)
P	0.9	0.97	0.74	0.57	0.37	0.29	0.64	0.9
< 60 yr (n = 181)	21 (5.1-57.6)	12.2 (4.1-40.9)	16.7 (3.7-42.9)	32.5 (10.4-62.6)	32 (9.8-59.4)	30.2 (9.2-57.7)	0.0 (0.0-4.1)	0.2 (0.0-9.8)
≥ 60 yr (n = 80)	22.7 (10.2-65.1)	13 (5.3-40)	15.6 (2.4-35.4)	37.8 (6.7-70.7)	37.2 (6.7-70.7)	35.2 (6.7-70.7)	0.0 (0-3.5)	0.2 (0-9.8)
P	0.08	0.8	0.1	0.2	0.2	0.12	0.76	0.54
MELD < 20 (n = 90)	19.4 (8-59.8)	11.6 (2.6-40.5)	18.3 (4.1-56.8)	38.9 (19.9)	38.4 (17-69.6)	35.9 (8.2-71.6)	0.0 (0-4.9)	0.8 (0-25.3)
MELD ≥ 20 (n = 171)	22.3 (5.7-58.6)	13 (4.4-40.3)	15.4 (3.2-42.2)	31.3 (9-62.2)	31 (9.1-61.5)	30 (9.1-60)	0.0 (0-4)	0.10 (0-9.6)
P	0.9	0.66	0.07	< 0.001	< 0.001	< 0.001	0.19	0.76
Not alcoholic (n = 216)	21.2 (5.6-58.7)	13.1 (4.1-41)	15.4 (1.8-32.4)	30.2 (2.8-70.4)	30 (2.8-70.4)	29 (2.8-70.4)	0.0 (0-1.4)	0.3 (0-6.9)
Alcoholic (n = 45)	22.5 (10.4-63.3)	12.8 (3.6-30.8)	15 (2.2-45.3)	33.9 (5.7-64.2)	33.8 (5.7-64.2)	33.1 (5.7-63.9)	0 (0-10.4)	0.4 (0-42.5)
P	0.68	0.81	0.2	0.16	0.18	0.19	0.95	0.97
HCV absence (n = 111)	21.8 (7.4-68.5)	11.5 (4.5-54.4)	16.7 (3-40.6)	37.6 (8.9-70.1)	36.6 (8.9-70.1)	33.9 (8.9-68.6)	0.0 (0.0-3.6)	0.4 (0-9.4)
HCV presence (n = 150)	21.5 (5.2-53.7)	13.1 (4.1-36)	15.7 (4-43.3)	31.4 (10.5-59.3)	30.9 (9.9-59.1)	30 (8.5-57.7)	0 (0-4.2)	0.15 (0-13.9)
P	0.31	0.62	0.43	0.013	0.021	0.023	0.65	0.43
HBV absence (n = 206)	22.0 (6.4-57.9)	13 (4.2-38.1)	16 (3.8-42.8)	33.9 (10.2-65.8)	33.6 (9.1-67.3)	31.2 (7.4-67)	0 (0-4)	0.3 (0-10.4)
HBV presence (n = 55)	21 (3.8-65)	11.2 (2-67.3)	16.7 (3.2-56.1)	33.3 (10.7-55.7)	32.5 (10.7-55.6)	30.1 (10.7-53.4)	0 (0-4.1)	0.4 (0-14.4)
P	0.34	0.4	0.36	0.25	0.2	0.16	0.74	0.99
Not cholestatic (n = 246)	21.7 (6.2-57.9)	12.3 (4.1-40)	15.5 (3.4-42.4)	33 (10.2-58.6)	32.1 (9.6-58.5)	30.2 (9-57.1)	0.0 (0-3.9)	0.4 (0-10.4)
Cholestatic (n = 15)	22.2 (NA)	11.5 (NA)	18.1 (NA)	53.4 (NA)	53.4 (NA)	53.3 (NA)	0.0 (NA)	0.3 (NA)
P	0.15	0.53	0.38	0.001	0.001	0.001	0.26	0.5
HCC absence (n = 154)	2.7 (7.6-65.6)	12.2 (4.2-42.2)	16.5 (3.1-42.9)	33.9 (10.7-65.1)	33 (10.7-62.8)	30.8 (9.7-62.8)	0 (0-4)	0.4 (0-9.1)
HCC presence (n = 107)	23.2 (4.8-55.8)	13 (4.1-39.6)	15.8 (3.4-42.8)	33.3 (9.3-64.9)	33.3 (8-64.9)	31.5 (8.3-64.6)	0.0 (0-3.4)	0.1 (0-12.5)
P	0.56	0.6	0.3	0.76	0.84	0.82	0.6	0.87

MELD: Model for End-stage Liver Disease; HCV: Hepatitis C virus; HBV: Hepatitis B virus; HCC: Hepatocellular carcinoma; r: Time to initial fibrin formation; k: Time to clot formation; α: Alpha angle, rate of clot formation; MA: Maximum amplitude, absolute clot strength; A30: Maximum amplitude at 30 min after MA; Ly30: Fibrinolysis at 30 min after MA; Ly60: Fibrinolysis at 60 min after MA.