| CTRI Number |
CTRI/2022/09/045959 [Registered on: 27/09/2022] Trial Registered Prospectively |
| Last Modified On: |
26/09/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Therapeutic Plasma Exchange by two different technologies (Centrifugal vs Membranous)] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study to Compare Response and Cost Implications Of Plasma Exchange In Renal Patients With Two Different Methods |
|
Scientific Title of Study
|
An Open Label Randomized Controlled Trial To Compare Plasma Removal Efficacy As Well As Cost Of Therapeutic Plasma Exchange By Two Different Technologies (Centrifugal Vs Membranous) In Nephrology Patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr DIVJOT SINGH LAMBA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH |
| Address |
Department of Transfusion Medicine, PGIMER, Chandigarh Chandigarh 160012
Sector 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9815464100 |
| Fax |
|
| Email |
div834@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr DIVJOT SINGH LAMBA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH |
| Address |
Department of Transfusion Medicine, PGIMER, Chandigarh Chandigarh 160012
Sector 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9815464100 |
| Fax |
|
| Email |
div834@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof RATTI RAM SHARMA |
| Designation |
PROFESSOR AND HEAD |
| Affiliation |
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH |
| Address |
Department of Transfusion Medicine, PGIMER, Chandigarh Chandigarh 160012
Sector 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087009482 |
| Fax |
|
| Email |
rrspgi@gmail.com |
|
|
Source of Monetary or Material Support
|
| POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH |
|
|
Primary Sponsor
|
| Name |
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH |
| Address |
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 = 1 |
| 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 and Dept. of Nephrology, Nehru Hospital PGIMER Chandigarh
Chandigarh CHANDIGARH
Chandigarh
CHANDIGARH |
9815464100
div834@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institute Ethics Committee (Intramural) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N29||Other disorders of kidney and ureter in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Therapetic plasma exchange by Membranous technology |
To assess efficacy of Therapeutic plasma exchange done by membranous technology, patients allocated randomly in this arm total 12 cases to be allocated randomly till March 2024 (Total duration 18months for the the comparator) |
| Intervention |
Therapeutic plasma exchange by Centrifugal Technology |
To asssess plasma removal efficacy of Therapeutic plasma exchange done by Centrifugal technology, patients allocated randomly in this arm total 12 cases to be allocated randomly till March 2024 (total duration 18 months of the intervention) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. No evidence of active infection
2. Willing to give informed consent for the procedure (In patients who are incompetent to consent, consent shall be taken from the surrogate)
3. Those who not enrolled in any other study
|
|
| ExclusionCriteria |
| Details |
1. Pregnancy
2. Microbiological or radiological evidence of active infection
3. Known allergy to Plasma, Protamine or Heparin.
4. Severe systemic illness like HIV
5. Patients with vasculitis due to secondary causes (diagnosis of a different rheumatic disease, Hepatitis B, Hepatitis C, HIV infection)
6. Mechanically ventilated patients
7. Renal or any other Transplant recipient will be excluded
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
a.Compare the plasma removal efficacy of centrifugal and membrane filtration technologies for TPE in nephrology patients
b.Compare the Post exchange clinical, biochemical, and hematological profile in the two
Groups
c.Calculation of the TPE procedure costs in the two modalities |
recruitment 18
months
results and
analysis 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient Outcome- Adverse events and Morbidity and mortality at 30 days and 90 days TPE cycle completion |
at 30 and 90 days post TPE cycle completion |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
30/09/2022 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The trial will be conducted in the Department of Transfusion Medicine in collaboration with Dept. of Nephrology of the Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh. A convenient sample size of twenty-four patients (twelve (12) in each group) who would fulfill the inclusion criteria to be enrolled in the study after obtaining written informed consent from the study participants, the patients will be randomized into either of the two study arms.
Group I: Patient who undergo Therapeutic plasma exchange by centrifugal technique (cTPE) after informed consent
Group II: Patient who undergo Therapeutic plasma exchange by membranous technique (mTPE) after informed consent
Baseline investigations and clinical details of the patients will be recorded and patients counselled by the clinician for the available therapies and randomly allocated into cTPE or mTPE group for assessing the efficacy of plasma removal by therapeutic plasma exchange as well cost involved in the procedures being done.
Primary and Secondary outcomes would be studied in the study participants and results evaluated when available. |