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CTRI Number  CTRI/2024/04/066207 [Registered on: 24/04/2024] Trial Registered Prospectively
Last Modified On: 14/05/2024
Post Graduate Thesis   
Type of Trial  Observational 
Type of Study   DESCRIPTIVE 
Study Design  Other 
Public Title of Study   To assess the bleeding complications following immunization and its management 
Scientific Title of Study   A descriptive study to assess the incidence of bleeding complications following immunization and prophylactic measures done to prevent bleeding complications in the patient with hemophilia in Kasturba Hospital, Manipal 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Sulochana B 
Designation  Associate professor  
Affiliation  Manipal College of Nursing 
Address  Department of Fundamentals of Nursing, Manipal College of Nursing, Madhav Nagar, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9844995784  
Fax    
Email  sulochana.k@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Sandra Mary Abraham 
Designation  Student, 4th year Bsc Nursing  
Affiliation  Manipal College of Nursing 
Address  Manipal College of Nursing, Madhav Nagar, Manipal, Udupi

Udupi
KARNATAKA
576104
India 
Phone  8848121106  
Fax    
Email  sandra.abraham@learner.manipal.edu  
 
Details of Contact Person
Public Query  
Name  Sandra Mary Abraham 
Designation  Student, 4th year BSc Nursing 
Affiliation  Manipal College of Nursing 
Address  Manipal College of Nursing, Madhav Nagar, Manipal, Udupi

Udupi
KARNATAKA
576104
India 
Phone  8848121106  
Fax    
Email  sandra.abraham@learner.manipal.edu  
 
Source of Monetary or Material Support  
NA 
 
Primary Sponsor  
Name  Manipal College of Nursing 
Address  Manipal College of Nursing, MAHE, Madhav Nagar, Manipal, Karnataka 
Type of Sponsor  Other [self] 
 
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 Sulochana B  KASTURBA HOSPITAL  KASTURBA HOSPITAL, MADHAV NAGAR, MANIPAL, UDUPI, KARNATAKA
Udupi
KARNATAKA 		 9844995784

sulochana.k@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D67||Hereditary factor IX deficiency, (2) ICD-10 Condition: D66||Hereditary factor VIII deficiency,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  80.00 Year(s)
Gender  Both 
Details  • Patients with hemophilia of any age group.
• Patients who have received immunizations.
• Patients with history of admission to KH, Manipal  
 
ExclusionCriteria 
Details  i)History of allergic reactions to immunizations.
ii) Patients taking anticoagulants.
iii) Patients who are unable to provide informed consent 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Insight on the bleeding complications following immunization in hemophilia patients.  4 weeks to 6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
insight on prophylactic measures to prevent bleeding complications.  24 HOURS 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   30/04/2024 
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="0"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 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   A descriptive to assess the incidence of bleeding complications following immunization and prophylactic measures done to prevent bleeding complications in the patient with hemophilia in Kasturba Hospital, Manipal. Hemophilia refer to a group of medical condition characterized  by abnormal bleeding due to the defect i  the coagulation system. These disorder can lead to a significant morbidity and mortality and have a substantial impact on patients quality of life.Patients with bleeding disorders often requires regular infusion of clotting factors to prevent bleeding episodes. Immunization is the crucial aspect of healthcare, especially for patients with bleeding disorders, However, there is a concern that immunization may increase the risk of bleeding in patients due to the potential for blrrding following immuniztion, The purpose of the study is to investigate immunization and the associated risk of bleeding and their management in individuals with bleeding disorders such as hemophilia. This will be useful in developing safe immunization practices in this population. 
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