An observational study in End Stage Renal Disease and Coagulopathy, sponsored by Institute of Liver and Biliary Sciences, India. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-12.
Sponsored by Institute of Liver and Biliary Sciences, India · Observational
Background: Coagulopathy in chronic kidney disease is multifactorial. Both hypocoagulopathy and hypercoaguability are seen. Conventional tests of coagulation (CCTs) end at the formation of thrombin, and do not take into account the interaction of coagulation factors, platelets, RBC etc. By overcoming the above deficiencies, thromboelastography provides a holistic picture of blood coagulation. The present study evaluated the TEG profile of ESRD patients and compared it to CCTs and to controls.
Methods: 50 ESRD patients and 50 controls were recruited for the study. Venous samples were withdrawn and platelet count, INR and fibrinogen levels were measured. Simultaneously a Thromboelastography was performed. All samples were drawn prior to initiation of dialysis.
A total of 100 patients were recruited for the study based on the above criteria.Following enrollment, patients were divided into two groups as follows Group 1(Control Group): 50 patients who were healthy voluntary donors belonging to ASA PSI or ASA PSII Group 2(ESRD Group): 50 patients suffering from end stage renal disease i.e. CKD stage 5 (Defined by KDIGO 2012) who never received renal replacement therapy (RRT
Exclusion Criteria:
Normal Healthy Volunteers
Device: Thromboelastography
Patients with ESRD who have not received hemodialysis. Patients with known bleeding disorders, coexisting liver diseases, those who were on antiplatelet or anticoagulant therapy and patients who had received red blood cells, fresh frozen plasma or platelet transfusions in the past three months were excluded from the study.
Device: Thromboelastography
A viscoelastic test of coagulation
To compare the maximum amplitude on a thromboelastography in patients of chronic kidney disease stage 5 with normal controls.
Maximum amplitude in whole blood will be measures by a standard kaolin thromboelastography in all patients and controls.
Time frame: 0 hr
To correlate the maximum amplitude with platelet count and fibrinogen levels in patients of chronic kidney disease
the maximum amplitude obtained on an thromboelastography denotes clot strength which depends on platelet count and fibrinogen levels. thus an attempt will be made to corelate these values with fibrinogen levels and platelet count.
Time frame: 0 hr
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This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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Institute of Liver and Biliary Sciences, India