| CTRI Number |
CTRI/2024/02/063206 [Registered on: 27/02/2024] Trial Registered Prospectively |
| Last Modified On: |
26/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Biological Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Guillain-Barré Syndrome: Choosing the Best Treatment - Plasma Exchange vs. Immunoglobulin Therapy |
|
Scientific Title of Study
|
Comparing the Therapeutic Modalities of Guillain–Barré Syndrome: Therapeutic Plasma Exchange versus Intravenous Immunoglobulin |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nilasish Pani |
| Designation |
PG student |
| Affiliation |
SCB Medical College and Hospital |
| Address |
Department of Transfusion Medicine, SCB MCH, Mangalabag, Cuttack
Cuttack ORISSA 753007 India |
| Phone |
8763181197 |
| Fax |
|
| Email |
paninilasish@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Smita Mahapatra |
| Designation |
Professor and HOD |
| Affiliation |
SCB Medical College and Hospital |
| Address |
Department of Transfusion Medicine, SCB MCH, Mangalabag, Cuttack
Cuttack ORISSA 753007 India |
| Phone |
8763181197 |
| Fax |
|
| Email |
dr.smitamahapatra@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Nilasish Pani |
| Designation |
PG student |
| Affiliation |
SCB Medical College and Hospital |
| Address |
Department of Transfusion Medicine, SCB MCH, Mangalabag, Cuttack
Cuttack ORISSA 753007 India |
| Phone |
8763181197 |
| Fax |
|
| Email |
paninilasish@gmail.com |
|
|
Source of Monetary or Material Support
|
| SCB Medical College and Hospital, Cuttack |
|
|
Primary Sponsor
|
| Name |
SCB Medical College and Hospital |
| Address |
Mangalabag, Cuttack |
| Type of Sponsor |
Government medical college |
|
|
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 Nilasish Pani |
SCB Medical College and Hospital |
Department of Transfusion Medicine, Department of Medicine, Department of Neurology, SCB Medical College and Hospital, Mangalabag, Cuttack Cuttack ORISSA |
8763181197
paninilasish@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, SCB Medical College and Hospital,Cuttack |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G610||Guillain-Barre syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
INTRAVENOUS IMMUNOGLOBULIN |
first line treatment for patients of Guillain Barre Syndrome
frequency: 2 gm per kg given over 5 days
total duration: 5 days |
| Intervention |
THERAPEUTIC PLASMA EXCHANGE |
first line treatment for patients of Guillain Barre Syndrome
frequency: 5 sessions over 10 days
total duration: 10 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Clinically and electro physiologically diagnosed cases of GBS with
The cases will be age and sex matched
Both procedures are indicated |
|
| ExclusionCriteria |
| Details |
1. Patients of GBS who have achieved plateau of GBS
2. Previous episodes of GBS
3. Pregnancy
4. Severe concurrent Medical illness like TB
5. Any one of these procedures contraindicated
6. Patients whose modality of treatment has been changed from IVIG to TPE or vice versa
7. Specific exclusions with atypical features such as-
a. Purely sensory symptoms
b. Cranial nerve palsies without significant limb weakness
c. Improvement of one or more disability grades before inclusion |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| A decrease in GBS Disability scale by 1 or more points at discharge as compared to the same at admission |
Patient will be evaluated as per GBS disability score throughout the treatment period and up to 6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| total cost of treatment in Indian Rupees |
from the day of admission to the day of discharge |
|
|
Target Sample Size
|
Total Sample Size="45" Sample Size from India="45"
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 4 |
|
Date of First Enrollment (India)
|
08/03/2024 |
| 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
|
Guillain–Barré syndrome (GBS) is the most common cause of acute flaccid paralysis worldwide, with an annual global incidence of approximately 1–2 per 100,000 person-year. Specific treatment of the patients comprises intravenous immunoglobulin (IVIG) or plasma exchange (PE). Majority of studies comparing either modalities of treatment has been conducted in developed countries with better Hospital infrastructure and mechanical ventilation facilities. Therefore it’s necessary to elicit the outcome of GBS in resource poor settings like ours. Moreover most of the studies comparing either modalities of therapy, have been done retrospectively. Further, studies evaluating functional neurological outcomes after IVIG or PE are lacking. Therefore with this study we aim to compare PE and IVIG as a first line treatment for patients with GBS in our setup in terms of neurological outcomes of the affected patients. This is a randomized parallel group trial consisting of 45 patients in each arm selected by convenient sampling and randomized via computerized random number generator, where adult patients of either sex with clinical and electrophysiological diagnosis of GBS will be included. Patients with comorbidities, those with clinical plateau of disease and those where either of the therapeutic modalities are contraindicated, will be excluded from the study. Therapy with either IVIG or PE will be started after randomization and patient will be evaluated as per GBS disability score throughout the treatment period at day 0,7,14, 28 and at 6 months. A decrease in GBS Disability scale by 1 or more points at discharge as compared to the same at admission will be considered as the outcome measure.
|