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

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 Venous samples were withdrawn and platelet count, INR and fibrinogen levels were measured.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

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Key information

Conditions

End Stage Renal Disease Cardiovascular Diseases Chronic Disease Coagulopathy Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy voluntary donors belonging to ASA PSI or ASA PSII
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

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

Treatment and study plan

Thromboelastography

Device

A viscoelastic test of coagulation

Primary outcomes

To compare the maximum amplitude on a thromboelastography in patients of chronic kidney disease stage 5 with normal controls.

Time frame: 0 hr

Maximum amplitude in whole blood will be measures by a standard kaolin thromboelastography in all patients and controls.

Secondary outcomes

To correlate the maximum amplitude with platelet count and fibrinogen levels in patients of chronic kidney disease

Time frame: 0 hr

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.

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Official study title

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

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2016
First posted: Sep 7, 2017
Registry last updated: Jun 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed