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出境医 / 临床实验 / Efficacy and Safety of Plasma Exchange Compared to Standard Medical Therapy in Patients With Severe Drug Induced Liver Injury With or Without Underlying Chronic Liver Disease.

Efficacy and Safety of Plasma Exchange Compared to Standard Medical Therapy in Patients With Severe Drug Induced Liver Injury With or Without Underlying Chronic Liver Disease.

Study Description
Brief Summary:
In this randomized study subject will be randomized into two groups Group A will receive Standard Medical Treatment (Albumin + High Caloric Diet) Group B will continue Standard Medical Treatment with High Volume Plasma Exchange. All other interventions will be at the discretion of clinicians.

Condition or disease Intervention/treatment Phase
Chronic Liver Disease Biological: High Volume Plasma Exchange Other: Standard Medical Treatment Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial to Study the Efficacy and Safety of Plasma Exchange Compared to Standard Medical Therapy in Patients With Severe Drug Induced Liver Injury With or Without Underlying Chronic Liver Disease.
Actual Study Start Date : July 9, 2019
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : July 1, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: High Volume Plasma Exchange with SMT

PLASMA EXCHANGE is therapeutic procedure in which blood of the patient is passed through a medical device which separates plasma from other components of blood. The plasma is removed and replaced with a replacement solution such as colloid solution (e.g., albumin and/or plasma) or a combination of crystalloid/colloid solution.Plasma exchange leads to removal of abnormal circulating plasma factor or a physiologic factor produced in excess (IG, NH3,protein bond toxins )and also exert a immunomodulatory activity.

Standard Medical Treatment (Albumin + High Caloric Diet)

 Biological: High Volume Plasma Exchange
PLASMA EXCHANGE is therapeutic procedure in which blood of the patient is passed through a medical device which separates plasma from other components of blood. The plasma is removed and replaced with a replacement solution such as colloid solution (e.g., albumin and/or plasma) or a combination of crystalloid/colloid solution.Plasma exchange leads to removal of abnormal circulating plasma factor or a physiologic factor produced in excess (IG, NH3,protein bond toxins )and also exert a immunomodulatory activity

Other: Standard Medical Treatment
Standard Medical Treatment (Albumin+High caloric diet)
Active Comparator: Standard Medical Treatment
Standard Medical Treatment (Albumin + High Caloric Diet)
 Other: Standard Medical Treatment
Standard Medical Treatment (Albumin+High caloric diet)
Outcome Measures
Primary Outcome Measures :
  1. Transplant free survival in both group [ Time Frame: Day 28 ]

Secondary Outcome Measures :
  1. Number of participants with the development of organ dysfunction or failure in both group [ Time Frame: Day 7 ]
  2. Number of participants with the development of organ dysfunction or failure in both group [ Time Frame: Day 15 ]
  3. Number of participants with the development of organ dysfunction or failure in both group [ Time Frame: Day 28 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age-18-70 years

  • Preferably Biopsy proven or history suggestive of DILI (Drug Induced Liver Injury)

    1. Grade IV DILI With T.B > 15
    2. DILI Manifesting as ACLF (Acute on chronic Liver failure) /ALF (Acute Liver Failure) with no transplant option

Exclusion Criteria:

  • Evidence of active infection
  • Refusal of consent or assent
  • Patients with clinical suspicion of irreversible brain injury
  • Pregnancy
  • HCC (Hepatocellular Carcinoma) or any other malignancy
  • Kidney failure
  • Portal vein thrombosis
  • Upper GastroIntestinal bleed
  • Transplant
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Dr Satyam Sinha, MD 01146300000 satyamsinhacmc5@gmail.com

Locations
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India
Institute of Liver & Biliary Sciences Recruiting
New Delhi, Delhi, India, 110070
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India
Tracking Information
First Submitted Date  ICMJE July 8, 2019
First Posted Date  ICMJE July 11, 2019
Last Update Posted Date July 11, 2019
Actual Study Start Date  ICMJE July 9, 2019
Estimated Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2019) 		Transplant free survival in both group [ Time Frame: Day 28 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2019)
  • Number of participants with the development of organ dysfunction or failure in both group [ Time Frame: Day 7 ]
  • Number of participants with the development of organ dysfunction or failure in both group [ Time Frame: Day 15 ]
  • Number of participants with the development of organ dysfunction or failure in both group [ Time Frame: Day 28 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Plasma Exchange Compared to Standard Medical Therapy in Patients With Severe Drug Induced Liver Injury With or Without Underlying Chronic Liver Disease.
Official Title  ICMJE A Randomized Controlled Trial to Study the Efficacy and Safety of Plasma Exchange Compared to Standard Medical Therapy in Patients With Severe Drug Induced Liver Injury With or Without Underlying Chronic Liver Disease.
Brief Summary In this randomized study subject will be randomized into two groups Group A will receive Standard Medical Treatment (Albumin + High Caloric Diet) Group B will continue Standard Medical Treatment with High Volume Plasma Exchange. All other interventions will be at the discretion of clinicians.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chronic Liver Disease
Intervention  ICMJE
  • Biological: High Volume Plasma Exchange
    PLASMA EXCHANGE is therapeutic procedure in which blood of the patient is passed through a medical device which separates plasma from other components of blood. The plasma is removed and replaced with a replacement solution such as colloid solution (e.g., albumin and/or plasma) or a combination of crystalloid/colloid solution.Plasma exchange leads to removal of abnormal circulating plasma factor or a physiologic factor produced in excess (IG, NH3,protein bond toxins )and also exert a immunomodulatory activity
  • Other: Standard Medical Treatment
    Standard Medical Treatment (Albumin+High caloric diet)
Study Arms  ICMJE
  • Experimental: High Volume Plasma Exchange with SMT

    PLASMA EXCHANGE is therapeutic procedure in which blood of the patient is passed through a medical device which separates plasma from other components of blood. The plasma is removed and replaced with a replacement solution such as colloid solution (e.g., albumin and/or plasma) or a combination of crystalloid/colloid solution.Plasma exchange leads to removal of abnormal circulating plasma factor or a physiologic factor produced in excess (IG, NH3,protein bond toxins )and also exert a immunomodulatory activity.

    Standard Medical Treatment (Albumin + High Caloric Diet)

    Interventions:
    • Biological: High Volume Plasma Exchange
    • Other: Standard Medical Treatment
  • Active Comparator: Standard Medical Treatment
    Standard Medical Treatment (Albumin + High Caloric Diet)
    Intervention: Other: Standard Medical Treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 9, 2019) 		30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2020
Estimated Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age-18-70 years

  • Preferably Biopsy proven or history suggestive of DILI (Drug Induced Liver Injury)

    1. Grade IV DILI With T.B > 15
    2. DILI Manifesting as ACLF (Acute on chronic Liver failure) /ALF (Acute Liver Failure) with no transplant option

Exclusion Criteria:

  • Evidence of active infection
  • Refusal of consent or assent
  • Patients with clinical suspicion of irreversible brain injury
  • Pregnancy
  • HCC (Hepatocellular Carcinoma) or any other malignancy
  • Kidney failure
  • Portal vein thrombosis
  • Upper GastroIntestinal bleed
  • Transplant
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Dr Satyam Sinha, MD 01146300000 satyamsinhacmc5@gmail.com
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04015570
Other Study ID Numbers  ICMJE ILBS-Cirrhosis-24
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Institute of Liver and Biliary Sciences, India
Study Sponsor  ICMJE Institute of Liver and Biliary Sciences, India
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Institute of Liver and Biliary Sciences, India
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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