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

Institute of Liver and Biliary Sciences, India

Status: Completed

Conditions: Coagulopathy; End Stage Renal Disease

Treatments: Device: Thromboelastography

Study type: Observational

Funder types: Other

Identifiers

NCT03275077

ILBS-TEG-001

Details and patient eligibility

About

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 Venous samples were withdrawn and platelet count, INR and fibrinogen levels were measured.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

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

Controls

Description:

Normal Healthy Volunteers

Treatment:

Device: Thromboelastography

ESRD patients

Description:

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.

Treatment:

Device: Thromboelastography