| CTRI Number |
CTRI/2026/01/100807 [Registered on: 12/01/2026] Trial Registered Prospectively |
| Last Modified On: |
12/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Therapeutic Plasma exchange practices in intensive care unit |
|
Scientific Title of Study
|
A study to describe indications,practices,outcome of therapeutic plasma exchange in tertiary care ICU |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyadharshan Shanmugam |
| Designation |
Post graduate Resident |
| Affiliation |
Department of critical care medicine, Apollo Main Hospital chennai |
| Address |
Gandhi nagar Nainarpalayam kallakurichi Tamilnadu
Department of critical care medicine Apollo Main Hospital Greams lane Thousand lights chennai
Chennai
TAMIL NADU
606301
India |
| Phone |
6374009621 |
| Fax |
|
| Email |
drspriyadharshan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Balaji Rajaraman |
| Designation |
Consultant |
| Affiliation |
Department of critical care medicine, Apollo Main Hospital |
| Address |
Department of critical care medicine Apollo Main Hospital Greams lane Thousand lights chennai
Chennai
TAMIL NADU
600006
India |
| Phone |
8098010637 |
| Fax |
|
| Email |
balajirajaram@icuconsultants.com |
|
Details of Contact Person
Public Query
|
| Name |
Balaji Rajaraman |
| Designation |
Consultant |
| Affiliation |
Department of critical care medicine, Apollo Main Hospital |
| Address |
Department of critical care medicine Apollo Main Hospital Greams lane Thousand lights chennai
Chennai
TAMIL NADU
600006
India |
| Phone |
8098010637 |
| Fax |
|
| Email |
balajirajaram@icuconsultants.com |
|
|
Source of Monetary or Material Support
|
| Department of critical care medicine Apollo Main Hospital 21,greams lane , Thousand lights chennai 600006 |
|
|
Primary Sponsor
|
| Name |
S Priyadharshan |
| Address |
Department of critical care medicine Apollo Main Hospital Greams lane Thousand lights chennai |
| Type of Sponsor |
Other [Self] |
|
|
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 S Priyadharshan |
Apollo main hospital |
Departmement of critical care medicine, 21-greams lane,thousand lights chennai 600006
Chennai
TAMIL NADU |
6374009621
drspriyadharshan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTE -BIO MEDICAL RESEARCH APOLLO HOSPITALS CHENNAI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M95||Other acquired deformities of musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All patients who underwent therapeutic plasma
exchange in Apollo Main Hospital between 2021
to 2024. |
|
| ExclusionCriteria |
| Details |
patients who are not underwent plasma exchange. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Events during procedure (hypotension,
tachycardia,desaturation- New oxygen
requirement,itching,Reason for stoppage of
session) |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Hospital Outcome - favorable /Disease remission
Duration of hospital stay
Duration of ICU stay
Duration of mechanical ventilation
In-hospital mortality
Other immunomodulatory therapies |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
30/01/2026 |
| 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="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
AIM -To describe the indications, practices, and outcome of therapeutic plasma exchange in a tertiary care ICU. Factors predicting favourable outcome in patients undergoing therapeutic plasma exchange.
STUDY POPULATION - All patients who underwent therapeutic plasma exchange in Apollo Main Hospital between 2021 to 2024.
The following data were collected
Demographic data
Diagnosis
Category of indication for TPE
Number of TPE sessions
Volume of Plasma exchanged
Type of replacement solution infused
outcome |