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

End Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03275077
• Other study ID #: ILBS-TEG-001
• Status: Completed
• Start date: March 12, 2016
• Est. completion date: December 22, 2016

Study information

• Verified date: June 2018
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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 Venous samples were withdrawn and platelet count, INR and fibrinogen levels were measured.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 22, 2016
• Est. primary completion date: December 22, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Coagulopathy
• End Stage Renal Disease
• Hemostatic Disorders
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Device:
• Thromboelastography
A viscoelastic test of coagulation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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