| CTRI Number |
CTRI/2025/03/083732 [Registered on: 28/03/2025] Trial Registered Prospectively |
| Last Modified On: |
25/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Outcome of Therapeutic Plasma Exchange in patients of Liver injury due to rodenticide
poisoning in a tertiary care centre in Western India without Liver Transplant facility |
|
Scientific Title of Study
|
Outcome of Therapeutic Plasma Exchange in patients of Liver injury due to rodenticide
poisoning in a tertiary care centre in Western India without Liver Transplant facility |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pravin Motilal Rathi |
| Designation |
Professor and Head of the Department |
| Affiliation |
Topiwala National Medical College And Bai Yamunabai Laxman Nair Charitable Hospital |
| Address |
717, 7th Floor, OPD Building, TNMC & BYL Nair Hospital
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9322406438 |
| Fax |
|
| Email |
m.vishal4089@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pravin Motilal Rathi |
| Designation |
Professor and Head of the Department |
| Affiliation |
Topiwala National Medical College And Bai Yamunabai Laxman Nair Charitable Hospital |
| Address |
717, 7 th Floor, OPD building, TNMC & BYL Nair Hospital
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9322406438 |
| Fax |
|
| Email |
m.vishal4089@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pravin Motilal Rathi |
| Designation |
Professor and Head of the Department |
| Affiliation |
Topiwala National Medical College And Bai Yamunabai Laxman Nair Charitable Hospital |
| Address |
717, 7th Floor, OPD building, TNMC & BYL Nair Hospital
Mumbai
MAHARASHTRA
400034
India |
| Phone |
09322406438 |
| Fax |
|
| Email |
m.vishal4089@gmail.com |
|
|
Source of Monetary or Material Support
|
| Topiwala National Medical College And Bai Yamunabai Laxman Nair Charitable Hospital, Dr. A. L. Nair Road, Mumbai - 400008 |
|
|
Primary Sponsor
|
| Name |
TNMC & BYL Nair Hospital |
| Address |
Topiwala National Medical College And Bai Yamunabai Laxman Nair Charitable Hospital, Dr. A. L. Nair Road, Mumbai - 400008 |
| 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 |
| Pravin Motilal Rathi |
TNMC & BYL Nair Hospital |
717, 7th Floor, OPD building, TNMC & BYL Nair Hospital
Mumbai
MAHARASHTRA |
09322406438
rathipmpp@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee for academic research projects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S00-T88||Injury, poisoning and certain other consequences of external causes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patients who have consumed rodenticide ( phosphorous compound) presenting with
a) Acute liver failure
b) Acute liver injury
|
|
| ExclusionCriteria |
| Details |
Patients not willing to participate
Patients who had taken rodenticide along with other hepatotoxic agents |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the survival benefit of Low volume Plasma Exchange in patients of liver injury due to rodenticide poisoning (phosphorous compound). |
From the time of admission till death/ discharge. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the improvement in liver function tests. (Total Bilirubin, Direct Bilirubin, SGOT, SGPT, Total Protein, Albumin, Alkaline Phosphatase, INR) |
From the time of admission till death/ discharge. |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
08/04/2025 |
| 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="2"
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
|
Therapeutic Plasma exchange is the treatment of choice in Acute liver failure. However, the timing of initiation of Plasma Exchange and the risk factors associated with high mortality has not been definitely established in Acute liver failure and injury due to Zinc phosphide poisoning. Alternate hypothesis: Earlier initiation of plasma exchange can lead to increased survival probability in patients with acute liver failure or acute liver injury. Null hypothesis: Time of initiation of plasma exchange does not change the survival probability of patients with acute liver failure or acute liver injury. Null hypothesis: Time of initiation of plasma exchange does not change the survival probability of patients with acute liver failure or acute liver injury. |