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CTRI Number  CTRI/2024/11/076372 [Registered on: 08/11/2024] Trial Registered Prospectively
Last Modified On: 27/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Instant measurement of hemoglobin level in the blood without collecting any blood sample 
Scientific Title of Study   Non-invasive method of assessing hemoglobin using optical spectroscopy 
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 Sornavalli V 
Designation  Post graduate 
Affiliation  Saveetha Medical College and Hospital 
Address  Department of General Medicine, Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai

Chennai
TAMIL NADU
602117
India 
Phone  8754411574  
Fax    
Email  sornavalli.7991@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Gowri Shankar 
Designation  Professor 
Affiliation  Saveetha Medical College and Hospital 
Address  Department of General Medicine, Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai

Chennai
TAMIL NADU
602117
India 
Phone  9840026683  
Fax    
Email  drgowrishankar.a@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr. Gowri Shankar 
Designation  Professor 
Affiliation  Saveetha Medical College and Hospital 
Address  Department of General Medicine, Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai

Chennai
TAMIL NADU
625002
India 
Phone  9840026683  
Fax    
Email  drgowrishankar.a@gmail.com  
 
Source of Monetary or Material Support  
Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai, Tamil nadu, India, PIN code - 602117 
 
Primary Sponsor  
Name  Saveetha Medical College and Hospital 
Address  Saveetha Nagar, Thandalam, Chennai - 602105 
Type of Sponsor  Research institution and hospital 
 
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 Gowri Shankar  Saveetha Medical College and Hospital  Department of General Medicine, Saveetha Nagar, Thandalam, Chennai - 602117
Chennai
TAMIL NADU 
9840026683

drgowrishankar.a@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Saveetha Medical College and Hospital -Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D50-D89||Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Age – 18 to 60 years
2. Ability to consent
3. Patients with a recently done complete blood count report within the past one week.

 
 
ExclusionCriteria 
Details  1. Age above 80 years or age less than 18 years
2. Inability to consent
3. Patients exhibiting signs or symptoms suggestive of active internal or external bleeding.
4. Patients with peripheral vascular disease, Raynaud’s disease, vasculitis.
5. Patients with bleeding diatheses, who are actively bleeding. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assessment of hemoglobin  At baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
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)   10/11/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sornavalli.7991@gmail.com].

  6. For how long will this data be available start date provided 01-06-2025 and end date provided 01-06-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

The traditional method of measuring hemoglobin levels involves the extraction of blood through venipuncture or fingerstick procedures. While these methods are well-established and accurate, they come with inherent drawbacks. It can be cumbersome for individuals with needle phobia and patients with bleeding disorders. In scenarios where doctors need to know the hemoglobin levels immediately, such as in cases of acute blood loss after a road traffic accident or profuse intra-operative bleed, this non-invasive method can provide a value almost instantly, compared to the traditional lab method. Finally, the most important reason is the less availability of labs and lab equipment in rural India and the increased turn-over time for lab results in semi-rural areas, where on-the-spot estimation of hemoglobin will be very useful.

 
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