| 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
|
|
|
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
|
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sornavalli.7991@gmail.com].
- 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.
- 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. |