| CTRI Number |
CTRI/2025/04/084781 [Registered on: 15/04/2025] Trial Registered Prospectively |
| Last Modified On: |
13/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Plasma exchange Low versus standard volume in two different groups] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Benefits of Low volume vs standard volume PLEX in Acute Liver Failure |
|
Scientific Title of Study
|
Comparing the efficacy of low volume vs standard volume plasma exchange in patients with Acute Liver Failure - A randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anu Ragavan |
| Designation |
Junior Resident |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of Transfusion Medicine, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8825831491 |
| Fax |
|
| Email |
dranuragavan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divjot Singh Lamba |
| Designation |
Additional Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of Transfusion Medicine, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9815464100 |
| Fax |
|
| Email |
div834@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divjot Singh Lamba |
| Designation |
Additional Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of Transfusion Medicine, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9815464100 |
| Fax |
|
| Email |
div834@gmail.com |
|
|
Source of Monetary or Material Support
|
| PGIMER CHANDIGARH SECTOR 12 160012 |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Medical Education and Research Chandigarh |
| Address |
Post Graduate Institute of Medical Education and Research Chandigarh (PGIMER) Sector 12 CHANDIGARH 160012 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Divjot Singh Lamba |
Post Graduate Institute of Medical Education and Research Chandigarh |
Dept of Transfusion Medicine Post Graduate Institute of Medical Education and Research Chandigarh 160012
Chandigarh
CHANDIGARH |
0919815464100
div834@gmail.com |
| Dr Sunil Taneja |
Post Graduate Institute of Medical Education and Research Chandigarh |
Dept of Hepatology Post Graduate Institute of Medical Education and Research Chandigarh 160012
Chandigarh
CHANDIGARH |
9592160444
drsuniltaneja20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (intramural) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B150||Hepatitis A with hepatic coma, (2) ICD-10 Condition: B162||Acute hepatitis B without delta-agent with hepatic coma, (3) ICD-10 Condition: B159||Hepatitis A without hepatic coma, (4) ICD-10 Condition: B169||Acute hepatitis B without delta-agent and without hepatic coma, (5) ICD-10 Condition: B178||Other specified acute viral hepatitis, (6) ICD-10 Condition: B179||Acute viral hepatitis, unspecified, (7) ICD-10 Condition: D899||Disorder involving the immune mechanism, unspecified, (8) ICD-10 Condition: K720||Acute and subacute hepatic failure, (9) ICD-10 Condition: K712||Toxic liver disease with acute hepatitis, (10) ICD-10 Condition: K754||Autoimmune hepatitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Low Volume Plasma Exchange in patients with Acute Liver Failure |
Low Volume Plasma Exchange in patients with Acute Liver Failure - Patients allocated randomly in this arm. Total 21 cases to be allocated |
| Comparator Agent |
Standard Volume Plasma Exchange in patients with Acute Liver Failure |
Standard Volume Plasma Exchange in patients with Acute Liver Failure - Patients allocated randomly in this arm. Total 21 cases to be allocated. |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed with acute liver failure as per EASL/INASL/AASLD criteria.
No evidence of active infection.
Willing to give informed consent.
Those who are not enrolled in any other study.
Patients who are not intended for liver transplantation. |
|
| ExclusionCriteria |
| Details |
Pregnancy.
Microbiological or radiological evidence of infection.
Known allergy to plasma, Protamine or Heparin.
Severe systemic illness like HIV.
Active hemorrhage.
Liver, Kidney or any other transplant recipients will be excluded.
Severe pre existing cardiopulmonary disease.
Coexisting HCC or any other malignancy.
Death within 24 hours of presentation. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess efficacy of plasma exchange in terms of mortality on day 30. |
To assess efficacy of plasma exchange in terms of mortality on day 30. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in ALFED score, SOFA score, Clinical Prognostic index, KCH criteria to be assessed on pre procedure and on day 1,3,5,7 post procedure. Hematological and biochemical parameters will be assessed. |
On day 0(pre procedure), post procedure day 1,3,5,7 |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
30/04/2025 |
| 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
|
The study will be conducted in the Department of Transfusion Medicine in collaboration with the Department of Hepatology (PGIMER, Chandigarh). A convenient sample size of 42 patients (21 in each group) to be enrolled in the study after obtaining a written informed consent. After enrollment in the study, the patients will be randomized into two groups.
Group I: Patients will undergo Low Voume Plasma Exchange, after informed consent. Group II: Patients will undergo Standard Volume Plasma Exchange, after informed consent. The baseline investigations and the clinical details will be recorded as per proforma. Patients will be randomized to low volume or standard volume plasma exchange. Primary and Secondary outcomes will be evaluated. |