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

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ClinicalTrials.gov Identifier: NCT02757170
Recruitment Status : Unknown
Verified April 2016 by Subrat Kumar Acharya, All India Institute of Medical Sciences, New Delhi.
Recruitment status was:  Recruiting
First Posted : May 2, 2016
Last Update Posted : May 2, 2016
Sponsor:
Information provided by (Responsible Party):
Subrat Kumar Acharya, All India Institute of Medical Sciences, New Delhi

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.

Condition or disease Intervention/treatment Phase
Acute on Chronic Liver Failure Cirrhosis Device: Thromboelastography Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Assessment of Coagulation Abnormalities in Acute on Chronic Liver Failure Patients Using Thromboelastography
Study Start Date : July 2015
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : July 2016

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Arm Intervention/treatment
Experimental: I
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
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.

Active Comparator: Group II
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
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.

Experimental: Group III
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
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.

Experimental: Group IV
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
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.




Primary Outcome Measures :
  1. Changes in r, k and MA- TEG parameters in ACLF [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. Comparison of r, k and MA- TEG parameters with conventional tests of coagulation (i.e PT, aPTT) [ Time Frame: 1 day ]
  2. Development of renal failure, progression of hepatic encephalopathy, variceal bleeding and sepsis in patients with r, k and MA- TEG parameters [ Time Frame: 28 days ]
  3. Death in patients with abnormal r, k and MA- TEG parameters [ Time Frame: 28 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02757170


Contacts
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Contact: Subrat K Acharya, DM 01126594425 subratacharya@gmail.com

Locations
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India
Dr. S K Acharya Recruiting
New Delhi, India, 110029
Contact: Subrat K Acharya, DM    01126594425    subratacharya@gmail.com   
Contact: Subrat K Acharya, DM    9868397200    subratacharya@hotmail.com   
Principal Investigator: Subrat k Acharya         
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
Investigators
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Principal Investigator: Subrat k Acharya, DM AIIMS, New Delhi

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Responsible Party: Subrat Kumar Acharya, Professor, Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier: NCT02757170     History of Changes
Other Study ID Numbers: IESC/T-203/05.05.15
First Posted: May 2, 2016    Key Record Dates
Last Update Posted: May 2, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Liver Failure
Hepatic Insufficiency
End Stage Liver Disease
Acute-On-Chronic Liver Failure
Liver Diseases
Digestive System Diseases
Liver Failure, Acute