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To Compare TEG (Thrombelastography) and Conventional Tests in CKD Patients

A Comparative Evaluation of Thromboelastogram and Conventional Coagulation Tests To Detect Coagulopathy in End Stage Renal Disease Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03275077
Enrollment
100
Registered
2017-09-07
Start date
2016-03-12
Completion date
2016-12-22
Last updated
2018-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Renal Disease, Coagulopathy

Keywords

End stage renal disease, ESRD, Thromboelastography, Fibrinogen

Brief summary

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 Venous samples were withdrawn and platelet count, INR and fibrinogen levels were measured.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.

Interventions

A viscoelastic test of coagulation

Sponsors

Institute of Liver and Biliary Sciences, India
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. Healthy voluntary donors belonging to ASA PSI or ASA PSII 2. 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

1. Patients on antiplatelet drugs, erythropoietin, desmopressin 2. Patients with known bleeding disorders like haemophilia, aplastic anaemia etc 3. Patients having coexisting liver diseases 4. Patients on dialysis 5. Patients who have received PRBC, FFPs or Platelet Transfusions in the past 3 months 6. Patients less than 18 years of age 7. Pregnant patients 8. Malignancy

Design outcomes

Primary

MeasureTime frameDescription
To compare the maximum amplitude on a thromboelastography in patients of chronic kidney disease stage 5 with normal controls.0 hrMaximum amplitude in whole blood will be measures by a standard kaolin thromboelastography in all patients and controls.

Secondary

MeasureTime frameDescription
To correlate the maximum amplitude with platelet count and fibrinogen levels in patients of chronic kidney disease0 hrthe 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026