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

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 Venous samples were withdrawn and platelet count, INR and fibrinogen levels were measured.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

Study Overview

• Status: Completed
• Conditions: End Stage Renal Disease; Coagulopathy
• Intervention / Treatment: Device: Thromboelastography

• Study Type: Observational
• Enrollment (Actual): 100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Controls; Normal Healthy Volunteers	Device: Thromboelastography; A viscoelastic test of coagulation
ESRD patients; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	0 hr

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	0 hr

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2016
• Primary Completion (Actual): December 22, 2016
• Study Completion (Actual): December 22, 2016

Study Registration Dates

• First Submitted: August 16, 2017
• First Submitted That Met QC Criteria: September 5, 2017
• First Posted (Actual): September 7, 2017

Study Record Updates

• Last Update Posted (Actual): June 12, 2018
• Last Update Submitted That Met QC Criteria: June 11, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: ESRD; End stage renal disease; Fibrinogen; Thromboelastography
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Urologic Diseases; Hematologic Diseases; Renal Insufficiency; Hemorrhagic Disorders; Renal Insufficiency, Chronic; Kidney Diseases; Hemostatic Disorders; Blood Coagulation Disorders; Kidney Failure, Chronic
• Other Study ID Numbers: ILBS-TEG-001