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

Completed

• Conditions: Coagulopathy; End Stage Renal Disease
• Interventions: Device: Thromboelastography

• Registration Number: NCT03275077
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

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 Venous samples were withdrawn and platelet count, INR and fibrinogen levels were measured.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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-12
• Primary Completion: 2016-12-22
• Study Completion: 2016-12-22
• Study First Submitted: 2017-08-16
• Study First Submitted QC: 2017-09-05
• Study First Posted: 2017-09-07
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-11
• Last Update Posted: 2018-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Controls	Thromboelastography	Normal Healthy Volunteers
ESRD patients	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.

Primary Outcome Measures

Name	Time	Method
To compare the maximum amplitude on a thromboelastography in patients of chronic kidney disease stage 5 with normal controls.	0 hr	Maximum amplitude in whole blood will be measures by a standard kaolin thromboelastography in all patients and controls.

Secondary Outcome Measures

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