| CTRI Number |
CTRI/2019/07/020247 [Registered on: 18/07/2019] Trial Registered Prospectively |
| Last Modified On: |
18/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of Plasma Exchange in Acute on Chronic Liver Failure(Liver Disease). |
|
Scientific Title of Study
|
A Randomized controlled trial of efficacy and Safety of Hemoperfusion or Plasma Exchange compared to standard medical therapy in patients With acute on chronic liver failure. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NCT04013113,Version no 1 dated 19/12/2018 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vinay Kumar |
| Designation |
Senior Resident,Hepatology |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Room No 1042,1st Floor
Institute of Liver and Biliary Sciences,D-1,Vasant Kunj, New Delhi-110070.
South
DELHI
110070
India |
| Phone |
01146300000 |
| Fax |
01146300025 |
| Email |
drvinaybr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinay Kumar |
| Designation |
Senior Resident,Hepatology |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Room No 1042,1st Floor
Institute of Liver and Biliary Sciences,D-1,Vasant Kunj, New Delhi-110070.
DELHI
110070
India |
| Phone |
01146300000 |
| Fax |
01146300025 |
| Email |
drvinaybr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shive Kumar Sarin |
| Designation |
Senior Professor,Hepatology |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Room No 23375,3rd Floor
Institute of Liver and Biliary Sciences,D-1,Vasant Kunj, New Delhi-110070.
South
DELHI
110070
India |
| Phone |
01146300000 |
| Fax |
01146300025 |
| Email |
shivsarin@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Liver and Biliary Sciences,D-1,Vasant Kunj, New Delhi-110070.
|
|
|
Primary Sponsor
|
| Name |
Institute of Liver and Biliary Sciences |
| Address |
Room No 1042,1st Floor
Institute of Liver and Biliary Sciences,D-1,Vasant Kunj, New Delhi-110070.
|
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vinay Kumar |
Institute of Liver and Biliary Science |
Room No 1042,1st Floor
Institute of Liver and Biliary Sciences,D-1,Vasant Kunj, New Delhi-110070.
South
DELHI |
01146300000
01146300025
drvinaybr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,ILBS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K769||Liver disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Plasma Exchange plus Standard Medical Therapy |
Standard Medical Treatment: Standard medical therapy only included as per requirement.nutritional therapy ( high calorie intake- 2400 Kcal/ day) Lactulose, bowel wash, albumin, terlipressin, antibiotics and anti-virals in hepatitis B reactivation will be continued and recorded.
Plasma Exchange: Fresh frozen plasma will be used as replacement fluid.TPE treatment shall be given on first day and continued on an a dailybasis/alternate day till the desired clinical or biochemical response is achieved.
The procedures of TPE and hemoperfusion will be stopped if any major side effects occur (described below), the patient expires or the patient is transplanted within 30 days (whichever is earlier).
|
| Comparator Agent |
Standard Medical Treatment |
standard medical therapy only included as per requirement.nutritional therapy ( high calorie intake- 2400 Kcal/ day) Lactulose, bowel wash, albumin, terlipressin, antibiotics and anti-virals in hepatitis B reactivation will be continued and recorded. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients diagnosed with ACLF as per APASL criteria will be included.
2) Age : 18-65 yrs.
|
|
| ExclusionCriteria |
| Details |
1) Patient with ischemic heart disease
2) Patient with chronic obstructive disease.
3) Patient with hepato cellular carcinoma.
4) Patient with extra hepatic malignancy.
5) Patient with chronic renal insufficiency.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Transplant free survival in all the group |
Day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Development of organ dysfunction in all the group |
Day 7,15 and 28 |
| New onset of sepsis in ll the groups |
Day 7,15 and 28 |
| Adverse Events in all groups |
Day 28 |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/07/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is done with the aim of finding the association between the
bilirubin and bile acids / DAMPS molecule with organ failures and
sepsis in the patients with acute on chronic liver failure . in this
study there are 2 parts in the first part people who satisfy the
eligibility criteria will be recruited and blood samples will be taken
and above mentioned molecules will be analyzed and association ,if any
with occurrences of organ failures / new onset sepsis will be analyzed .
In the second part of the study the patients who meet the criteria
will be randomized to either receive standard medical therapy or with
either haemoperfusion or therapeutic plasma exchange with standard
medical therapy . blood samples will be taken and stored, bile acids
(primary and secondary bile acids, bilirubin and damps molecules will
be analysed .the patients are followed for 90 days , then statistical
analysis will be done to find the association with organ failures and
new onset sepsis . |