| CTRI Number |
CTRI/2024/04/065489 [Registered on: 09/04/2024] Trial Registered Prospectively |
| Last Modified On: |
17/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study On Clinical Profile And Outcome Of Thrombotic Microangiopathy |
|
Scientific Title of Study
|
A Study On Clinical Profile And Outcome Of Thrombotic Microangiopathy |
| Trial Acronym |
TMA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jagadeesh Mullapudi |
| Designation |
post graduate |
| Affiliation |
Kasturba Medical College |
| Address |
Nehru hostel room no 540
Department of General Medicine
Kasturba Medical College
madhav nagar
Manipal
Udupi KARNATAKA 576104 India |
| Phone |
8184847088 |
| Fax |
|
| Email |
jagadish.mulapudi@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Rama Bhat |
| Designation |
Professor and Head of Unit |
| Affiliation |
Kasturba Medical College |
| Address |
professor and HOU
Department of General Medicine
Kasturba Medical College
madhav nagar
manipal
Udupi KARNATAKA 576104 India |
| Phone |
9945272251 |
| Fax |
|
| Email |
ram.bhat@manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Dr Rama Bhat |
| Designation |
Professor and Head of Unit |
| Affiliation |
Kasturba Medical College |
| Address |
Professor and HOU
Department of General medicine
Kasturba Medical College
madhav nagar
Manipal
Udupi KARNATAKA 576104 India |
| Phone |
9945272251 |
| Fax |
|
| Email |
ram.bhat@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College,
Madhav nagar
manipal
udupi district
karnataka-576104
|
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College Manipal |
| Address |
Kasturba Medical College
Manipal
Udupi Karnataka
576104 |
| Type of Sponsor |
Private 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 Jagadeesh Mullapudi |
Kasturba Medical College Manipal |
Department of General Medicine
Kasturba Medical College
Madhav nagar
Manipal Udupi KARNATAKA |
8184847088
jagadish.mulapudi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KASTURBA MEDICAL COLLEGE AND KASTURBA HOSPITAL INSTITUTIONAL ETHICS COMMITTEE-2(STUDENT RESEARCH) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M311||Thrombotic microangiopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with thrombotic microangiopathy and its causes will be recruited after taking consent |
|
| ExclusionCriteria |
| Details |
secondary causes related to pregnancy will and age less than 18 yrs will be excluded |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
etiology of thrombotic micro angiopathy
clinical features at presentation
biochemical and hematological investigations
treatment received during the stay of hospital |
AT THE TIME OF PRESENTATION/ADMISSION
AT TIME OF DISCHARGE/DEATH
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
improved /discharged
death |
at the time of discharge/death |
|
|
Target Sample Size
|
Total Sample Size="66" Sample Size from India="66"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/04/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
NEED FOR STUDY TMA includes several severe conditions such as thrombotic thrombocytopenic purpura (TTP) and hemolytic uremic syndrome (HUS), which can be life-threatening if not promptly diagnosed and treated. Understanding the mechanisms underlying TMA can provide insights into broader aspects of vascular biology, coagulation pathways, and immune responses, contributing to the development of new treatments not only for TMA but also for other related conditions. TMA can present with nonspecific symptoms and mimic other disorders, making diagnosis challenging. Research in this area aims to improve diagnostic strategies and biomarkers for early detection. Research in TMA has led to the development of targeted therapies, such as plasma exchange for TTP and eculizumab for atypical HUS, highlighting the importance of ongoing studies for further therapeutic advancements. Understanding the epidemiology of TMA, including risk factors and outcomes, is crucial for public health planning and resource allocation Studying TMA can lead to improved management strategies, resulting in better outcomes and quality of life for affected individuals. Overall, research on thrombotic microangiopathy is essential for advancing our understanding of this complex group of disorders and improving clinical outcomes for patients. DESCRIPTION OF STUDY Patients will be recruited based on the above mentioned inclusion and exclusion criteria and after taking consent. Case history will be recorded in the proforma . Detailed medical history will be obtained regarding present complaints. Hematological and biochemical parameters will be recorded as per proforma and analyzed. The course of treatment during hospital stay will be analyzed and type of treatment the patient received will be recorded The outcome of the treatment given at the time of discharge will be recorded. The data collected will be analyzed using appropriate statistical methods. No additional tests will be done |