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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-12

Study Completion Date

2016-12-22

Brief Summary

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 Venous samples were withdrawn and platelet count, INR and fibrinogen levels were measured.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

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Conditions

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End Stage Renal Disease Coagulopathy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Controls

Normal Healthy Volunteers

Thromboelastography

Intervention Type DEVICE

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.

Thromboelastography

Intervention Type DEVICE

A viscoelastic test of coagulation

Interventions

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Thromboelastography

A viscoelastic test of coagulation

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes