| CTRI Number |
CTRI/2024/09/073862 [Registered on: 12/09/2024] Trial Registered Prospectively |
| Last Modified On: |
11/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of plasma exchange along with Standard Medical Treatment in comparison to Standard Medical Treatment alone in patients with acute on chronic failure |
|
Scientific Title of Study
|
Efficacy of plasma exchange in patients with acute on chronic Liver failure A randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sandeep Nijhawan |
| Designation |
Senior Professor and Head of Department |
| Affiliation |
SMS Medical College and Hospital, Jaipur |
| Address |
Department of Gastroenterology, Room no. 313, 3rd floor, SMS Superspeciality Hospital , Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9829272233 |
| Fax |
|
| Email |
sandeepnijhawan16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep Nijhawan |
| Designation |
Senior Professor and Head of Department |
| Affiliation |
SMS Medical College and Hospital , Jaipur |
| Address |
Department of Gastroenterology, Room no. 313, 3rd floor, SMS Superspeciality Hospital , Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9829272233 |
| Fax |
|
| Email |
sandeepnijhawan16@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manasvin Sareen |
| Designation |
Senior Resident |
| Affiliation |
SMS Medical College and Hospital, Jaipur |
| Address |
Department of Gastroenterology, Room no. 313, 3rd floor, SMS Superspeciality Hospital , Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
8619580422 |
| Fax |
|
| Email |
manasvinsareen7@gmail.com |
|
|
Source of Monetary or Material Support
|
| SMS Medical College and Hospital, Jaipur, 302004 , Rajasthan , India |
|
|
Primary Sponsor
|
| Name |
MMCSBY Scheme Government of Rajasthan |
| Address |
Department of Gastroenterology, Room no. 313, 3rd floor, SMS Superspeciality Hospital , Jaipur - 302004 |
| 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 Sandeep Nijhawan |
Sawai Man Singh Medical College and Hospital, Jaipur, Rajasthan |
Department of Gastroenterology, Room no. 313, 3rd floor, SMS Superspeciality Hospital , Jaipur- 302004
Jaipur
RAJASTHAN |
9829272233
sandeepnijhawan16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office Of Ethics Committee SMS Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
PLEX arm |
Plasmapheresis along with Standard Medical Treatment. 3 sessions of plasmapheresis will be targeted on alternate days during the hospital stay of the patient and Standard Medical treatment will be continued during the hospital stay. |
| Comparator Agent |
SMT arm |
Standard Medical Treatment will be given during the hospital stay of the patient. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All ethologies of ACLF as per APASAL criteria will be included in the study. |
|
| ExclusionCriteria |
| Details |
Active sepsis
Hemodynamic instability
HIV infection
Malignancy
HCC
Pregnancy
Alcoholic hepatitis and Severe Alcoholic hepatitis |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare survival over 30 days in PLEX and SMT arm |
To compare survival over 30 days in PLEX and SMT arm |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in renal dysfunction
Improvement in hepatic encephalopathy
Duration of hospital stay
PLEX related complications
Serial plasma levels of vWF |
30 days |
|
|
Target Sample Size
|
Total Sample Size="22"
Sample Size from India="22"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
23/09/2024 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
ACLF has a high short term mortality with the Standard Medical Treatment (SMT). Liver Transplantation (LT) is the only curative treatment. There are many devices that aim to artificially support liver function to bridge patients to liver transplantation and eventually allow for recompensation. Theraupeutic plasma exchange (PLEX) has shown to improve survival in few studies but has not been validated yet. Purpose of this study is to statistically compare and evaluate the 30 day survival in ACLF patients in PLEX patients vs SMT group. Also, improvement in renal failure , hepatic encephalopathy , PLEX related complications , duration of hospital stay , serial vWF levels are compared. |