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In chronic kidney disease (CKD), evaluation of hemostatic ability is essential for the short-term and long-term management of thrombotic and bleeding episodes. Coagulopathy in CKD cannot be evaluated using standard coagulation screening alone. Sonoclot is a global coagulation test that gives real-time coagulation status snapshot and comprehensive analysis with a short turnaround time in a small amount of sample. We have previously shown that some sonoclot parameters are associated with thrombotic events while Conventional coagulation tests are not associated with either clinical bleeding or thrombotic events. The association of coagulation factors (CFs) with bleeding and thrombotic episodes and the correlation of CFs with conventional tests and Sonoclot has not been reported earlier in dialysis patients.
This is a prospective observational single arm cross-sectional study conducted at
Department of Nephrology, PGIMER, Chandigarh, India. All patients with chronic kidney disease on dialysis above 18 years of age were included. Exclusion criteria: Pre-existing diseases of coagulation, sepsis, disseminated intravascular coagulation, malignancy, patient on continuous therapeutic anticoagulation, pregnancy. Consecutive 50 patients satisfying these criteria were enrolled for this study. Predialysis sample was taken and tested for conventional coagulation tests, sonoclot and coagulation factors.Study was conducted as per principles for medical research by declaration of Helsinki. This study is registered with CTRI number: CTRI/2020/10/028389.
Out of all fifty patients (n= 15), 30 % were diabetic, followed by (n = 22) 44% were hypertensive, and (n=13 )26% of other diseases. The mean age was 40.54 ± 15.9 years. 37 (74%) were males, and 13 (26%) were females. 5 patients had thrombotic events and 7 had bleeding events during admission. The baseline characteristics and investigations are shown in Table 1.
There was no significant association was found in coagulation factors levels with bleeding & thrombotic episodes, as shown in Table 2 of the univariate logistic regression analysis. Tables 3 and 4 show correlations of CFs and conventional and sonoclot parameters.
INR was found to be associated with Factor 8 but this was not clinically corroborating and biologically implausible. Amongst the sonoclot parameters, as shown in table 4. Factor 8, F10, VWF, and factor tPA were correlated moderately with HGB PA, HGB PF, GB CR, and GB PF respectively, but were not clinically relevant.
Table1: Baseline characteristics (n=50)
characteristics
Mean
Median(IQR)
Baseline investigations
Haemoglobin (g/dl)#
8.05
(1.70)
TLC (Cells per mm3)#
7674.00
(2933.39)
Platelets (1000 per microliter)#
168.46
(79.64)
Urea (mg/dl)#
134.49
(81.60)
Creatinine (mg/dl)#
9. 720
(4.63)
SGOT(AST)#
32.59
(6.7)
SGPT(ALT)#
37.10
(7.4)
Bilirubin total #
1.8
(1)
Coagulation Factors and their normal range as measured in healthy subjects [mean (range)]
Interquartile range
F83.5(1.5-5.8)
9.3
(2.6 - 12.2)
F109.8(4-13)
5.4
(3.1 - 8.0)
tPA6.5(5-15)
40.4
(21.9 - 54.6)
VWF14.5(12-18)
10.6
(4.0 - 15.0)
PAI1.8(0.5-2.2)
7.0
(2.9-11.9)
Sonoclot Parameter with normal range
GB_ACT(100-155Sec)
153
(122.0 - 206.0)
GB_CR(9-35 signals unit/min)
34.5
(26.0 - 46.0)
GB_PA75-100 signals units)
92.8
(85.0 - 100.0)
GB_TIMETOPEAK(10-15 min)
6.3
GB_PFPlatelet Function (>1.5)
4.3
(3.1 - 4.8)
HGB_ACT
165.5
(135.0 - 195.8)
HGB_CR
32.0
(23.0 - 44.0)
HGB_PA
100.0
(95.0 - 105.0)
HGB_TIMETOPEAK
6.8
(5.4 - 8.0)
HGB PF
4.4
(3.7 - 4.8)
None of the coagulation factors were associated with bleeding or thrombotic events.
There no clinically relevant correlation between any of the conventional tests and coagulation factors. Moderately significant and plausible correlations were found between Factor 8, F10, VWF and factor tPA and HGB PA, GB CR, HGB PF, GB PF respectively Role of real time tests like Sonoclot need to be evaluated further.