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

NCT03275077 | Completed

• 1 other identifier: ILBS-TEG-001
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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 Venous samples were withdrawn and platelet count, INR and fibrinogen levels were measured.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

Conditions

End Stage Renal Disease; Coagulopathy

Keywords

End stage renal disease; ESRD; Thromboelastography; Fibrinogen

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To correlate the maximum amplitude with platelet count and fibrinogen levels in patients of chronic kidney disease

  0 hr

Study Arms (2)

Controls

Normal Healthy Volunteers

Device: Thromboelastography

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

Interventions

Thromboelastography DEVICE

A viscoelastic test of coagulation

Controls; ESRD patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Healthy voluntary donors belonging to ASA PSI or ASA PSII
• Patients suffering from end stage renal disease i.e. CKD stage 5 (Defined by KDIGO 2012 ) who never received renal replacement therapy (RRT)

You may not qualify if:

• Patients on antiplatelet drugs, erythropoietin, desmopressin
• Patients with known bleeding disorders like haemophilia, aplastic anaemia etc
• Patients having coexisting liver diseases
• Patients on dialysis
• Patients who have received PRBC, FFPs or Platelet Transfusions in the past 3 months
• Patients less than 18 years of age
• Pregnant patients
• Malignancy

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

MeSH Terms

Conditions

Kidney Failure, Chronic; Hemostatic Disorders

Interventions

Thrombelastography

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Blood Coagulation Tests; Hematologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asssitant Professor, Department of Anaesthesiology

Study Record Dates

• First Submitted: August 16, 2017
• First Posted: September 7, 2017
• Study Start: March 12, 2016
• Primary Completion: December 22, 2016
• Study Completion: December 22, 2016
• Last Updated: June 12, 2018

Record last verified: 2018-06