| CTRI Number |
CTRI/2024/07/071421 [Registered on: 26/07/2024] Trial Registered Prospectively |
| Last Modified On: |
25/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Abnormalities of thrombotic factor in children and adolescents hospitalized with a relapse of nephrotic syndrome |
|
Scientific Title of Study
|
Evaluation of pro-thrombotic factors in children and adolescents hospitalized with a relapse of nephrotic syndrome |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mansi Gupta |
| Designation |
Post Graduate Student |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Pediatrics
Maulana Azad Medical College and Associated Lok Nayak Hospital
New Delhi
New Delhi
DELHI
110002
India |
| Phone |
8130739499 |
| Fax |
|
| Email |
mansigupta034@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mukta Mantan |
| Designation |
Director professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Pediatrics
Maulana Azad Medical College and Associated Lok Nayak Hospital
New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9968604315 |
| Fax |
|
| Email |
muktamantan@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mansi Gupta |
| Designation |
Post Graduate Student |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Pediatrics
Maulana Azad Medical College and Associated Lok Nayak Hospital
New Delhi
New Delhi
DELHI
110002
India |
| Phone |
8130739499 |
| Fax |
|
| Email |
mansigupta034@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatrics, Maulana Azad Medical College and associated Lok Nayak Hospital
Bahadur Shah Zafar Marg
New Delhi
Delhi
110002 |
|
|
Primary Sponsor
|
| Name |
Department of Pediatrics Maulana Azad Medical College |
| Address |
2,Bahadur Shah Zafar Marg, near Delhi Gate, Balmiki Basti, New Delhi, Delhi, 110002 |
| 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 Mansi Gupta |
Lok Nayak Hospital |
Department of Pediatrics
Maulana Azad Medical College and associated Lok Nayak Hospital
Bahadur Shah Zafar Marg
New Delhi
DELHI |
8130739499
mansigupta034@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Maulana Azad Medical College and Associated Hospitals (Lok Nayak, G.B Pant Institute of Post Graduate Medical Education (GIPMER) and Research Hospital, Guru Nanak Eye Centre, New Delhi- 110002) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N049||Nephrotic syndrome with unspecified morphologic changes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children and adolescents hospitalized with a relapse of nephrotic syndrome |
|
| ExclusionCriteria |
| Details |
1. Presence of concomitant acute hepatitis/ liver disease
2. Already on anticoagulants
3. Patients admitted for renal biopsy
4. Congenital nephrotic syndrome
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients with altered levels of antithrombin III, Protein C, Protein S |
At admission and at discharge /2 weeks of hospitalization whichever is earlier |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients with altered coagulation profile parameters (PT/INR/aPTT/Platelet count) |
At admission and at discharge /2 weeks of hospitalization whichever is earlier |
| Proportion of patients with altered D-Dimer, Fibrinogen and FDP |
At admission and at discharge /2 weeks of hospitalization whichever is earlier |
| Proportion of patients with presence of Factor V Leiden mutation |
At admission and at discharge /2 weeks of hospitalization whichever is earlier |
| Association of Prothrombotic factors with disease type, duration, therapy, presence of infection and hypovolemia |
At admission and at discharge /2 weeks of hospitalization whichever is earlier |
|
|
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)
|
08/08/2024 |
| 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
|
This cross-sectional study will be conducted in the Department of Pediatrics at Maulana Azad Medical College and associated Lok Nayak Hospital, New Delhi includes 40 children and adolescents aged 2-18 years hospitalized with a relapse of nephrotic syndrome. This study aimed to determine the proportion of children and adolescents with nephrotic syndrome having altered prothrombotic factors with disease relapse. The primary objective is to measure levels of antithrombin III, Protein C, Protein S in children and adolescents hospitalized with a relapse of nephrotic syndrome (both steroid sensitive and steroid resistant nephrotic syndrome ) at admission and at discharge / 2 weeks whichever is earlier. As children with complicated relapses need hospitalization for treatment and more likely to be predisposed to thromboembolism , we decided to study factors contributory for development of thromboembolism. |