Assessment of Coagulation Abnormalities in Acute on Chronic Liver Failure Patients Using Thromboelastography

NCT02757170 | Unknown Phase 4 DMC

• 1 other identifier: IESC/T-203/05.05.15
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Patients of acute \& chronic liver failure have long been assumed to have coagulopathy \& are given blood products prophylactically as well as during various interventions. But these patients rarely have spontaneous bleed except variceal bleed. Conventional coagulation parameters are insufficient to assess coagulation status of these patients because they reflect only a certain element of coagulation cascade while thromboelastography (TEG) gives a comprehensive report of hemostatic profile including platelet function. Studies using TEG have suggested that defects in prohemostatic drivers are counterbalanced by changes in antihemostatic drivers creating a rebalance in these patients. Acute on chronic failure is a entity with acute decompensation on underlying chronic liver failure. Since there is paucity of data regarding coagulation abnormalities in these patient, study is needed to assess predictability power of TEG in these patients with respect to coagulation abnormalities in patient with ALF and CLD ( cirrhosis) and healthy controls.

Conditions

Acute on Chronic Liver Failure; Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Changes in r, k and MA- TEG parameters in ACLF

  1 day

Secondary Outcomes (3)

• Comparison of r, k and MA- TEG parameters with conventional tests of coagulation (i.e PT, aPTT)

  1 day

• Development of renal failure, progression of hepatic encephalopathy, variceal bleeding and sepsis in patients with r, k and MA- TEG parameters

  28 days

• Death in patients with abnormal r, k and MA- TEG parameters

  28 days

Study Arms (4)

I

EXPERIMENTAL

Thromboelastography Acute on chronic liver failure: Patients' whole blood will be taken and subjected to undergo coagulation with thromboelastometry and various graphic tracings will be recorded which will highlight the process of coagulation in these patients

Device: Thromboelastography

Group II

ACTIVE COMPARATOR

Thromboelastography Healthy Controls: Healthy persons' whole blood will be taken and subjected to undergo coagulation with thromboelastometry and various graphic tracings will be recorded which will highlight the process of coagulation.

Device: Thromboelastography

Group III

EXPERIMENTAL

Thromboelastography Chronic Liver Failure: Patients' whole blood will be taken and subjected to undergo coagulation with thromboelastometry and various graphic tracings will be recorded which will highlight the process of coagulation in these patients

Device: Thromboelastography

Group IV

EXPERIMENTAL

Thromboelastography Acute Liver Failure: Patients' whole blood will be taken and subjected to undergo coagulation with thromboelastometry and various graphic tracings will be recorded which will highlight the process of coagulation in these patients

Device: Thromboelastography

Interventions

Thromboelastography DEVICE

Patients whole blood will be subjected to undergo coagulation process under monitoring with thromboelastography and various tracings will be recorded and will be interpreted as results.

Group II; Group III; Group IV; I

Eligibility Criteria

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

You may qualify if:

• All consecutive ALF, ACLF \& cirrhotic patients and healthy controls
• Written informed consent (patient or his nearest relative)

You may not qualify if:

• Patients on anti-platelet or anticoagulant therapy
• Pregnancy and immediate post-partum period
• History of underlying hypercoagulable/ hypocoagulable states eg. PNH, Polycythemia, Hemophilia
• Patients with renal failure

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

Study Sites (1)

Dr. S K Acharya

New Delhi, New Delhi, 110029, India

RECRUITING

MeSH Terms

Conditions

Acute-On-Chronic Liver Failure; Fibrosis

Interventions

Thrombelastography

Condition Hierarchy (Ancestors)

Liver Failure, Acute; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Subrat k Acharya, DM

  AIIMS, New Delhi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Subrat K Acharya, DM

CONTACT

01126594425; subratacharya@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Gastroenterology

Study Record Dates

• First Submitted: April 25, 2016
• First Posted: May 2, 2016
• Study Start: July 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: May 2, 2016

Record last verified: 2016-04

Locations

IN (1)