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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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
 
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