| CTRI Number |
CTRI/2017/12/010820 [Registered on: 11/12/2017] Trial Registered Prospectively |
| Last Modified On: |
07/12/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to determine if a new therapy(High Volume Plasma Exchange) can help in recovery of Acute on chronic Liver failure. |
|
Scientific Title of Study
|
Role of High Volume Plasma Exchange in Acute on chronic Liver failure: A Pilot Randomized Control Trial. |
| Trial Acronym |
HVPE-ACLF |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shalimar |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room No. 127, first floor, Old OT Block, Department of Gastroenterology and Human Nutrition Unit
Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
9868397211 |
| Fax |
|
| Email |
drshalimar@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shalimar |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room No. 127, first floor, Old OT Block, Department of Gastroenterology and Human Nutrition Unit
Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
9868397211 |
| Fax |
|
| Email |
drshalimar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shalimar |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room No. 127, first floor, Old OT Block, Department of Gastroenterology and Human Nutrition Unit
Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
9868397211 |
| Fax |
|
| Email |
drshalimar@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
Ansari Nagar,New Delhi-110029, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Shalimar |
All India Institute of Medical sciences |
AB2 ward, Department of Gastroenterology
South
DELHI |
9868397211
drshalimar@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS, New Delhi-110029 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Acute on Chronic Liver Failure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
High Volume Plasma Exchange plus Standard therapy |
Removal of 15% of ideal body weight equivalent of plasma and replacement with transfusion of fresh frozen plasma.
In addition standard of care presently-
Supportive therapy including ventilatory support, inotropes for blood pressure, maintenance of blood sugar and electrolytes, antibiotics and antiviral drugs as indicated |
| Comparator Agent |
Standard therapy |
Standard of care- Supportive therapy including ventilatory support, inotropes for blood pressure, maintenance of blood sugar and electrolytes, antibiotics and antiviral drugs as indicated |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Written informed consent.
2. > 18 years of age.
3. ACLF grade 1 or 2.
|
|
| ExclusionCriteria |
| Details |
1. ACLF grade 3
2. Systolic blood pressure < 90 mm Hg
3. Lack of informed consent
4. Coexisting severe illness eg. coronary artery disease, malignancy etc
5. Post Liver Transplant patients
5. Pregnancy
6. Active infection- bacterial or fungal.
7. Hepatocellular carcinoma
|
|
|
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 study the effect of high volume plasma (HVP) exchange on 28 day mortality in patients with alcohol-related ACLF. |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the effect of HVP on CLIF-C ACLF score, APACHE II and SIRS.
To study the effect of HVP on resolution of organ failures in ACLF.
To study the effect of high volume plasma exchange on cytokine profile in ACLF.
To study the incidence of infections and other complications in ACLF patients undergoing high volume plasma exchange
|
1 month
1 month
1 month
1 month |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
18/12/2017 |
| 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
|
Not Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Alcohol related Acute on Chronic Liver Failure (ACLF) is associated with high mortality. Presently the only definite therapy is Liver Transplantation. These patients are sick and are at risk of developing infections which make them poor candidates for Liver Transplant. In order to improve the outcome in these patients, we plan to use high volume plasma (HVP) exchange. HVP has been shown to be beneficial in patients with Acute Liver Failure and also in ACLF (reported as case reports). In this Randomized control trial, we plan to treat one arm with HVP and standard therapy and the other arm with Standard therapy alone. The result might be useful in changing the management protocol for ACLF. |