| CTRI Number |
CTRI/2021/05/033689 [Registered on: 20/05/2021] Trial Registered Prospectively |
| Last Modified On: |
12/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study on the factors influencing the ABO blood group antibodies among the donor population of Southern Karnataka, India |
|
Scientific Title of Study
|
A cross-sectional study on determination of ABO isoagglutination titres and factors influencing them among blood donor population of Southern Karnataka, India |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bemma Paonam |
| Designation |
Junior Resident |
| Affiliation |
KMC, Manipal |
| Address |
Department of Immunohematology and Blood Transfusion, Kasturba Medical College, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8259956659 |
| Fax |
|
| Email |
abepaonam12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shamee Shastry |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Immunohematology and Blood Transfusion,
Kasturba Medical College, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9743489837 |
| Fax |
|
| Email |
shameeshastry@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shamee Shastry |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Immunohematology and Blood Transfusion,
Kasturba Medical College, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9743489837 |
| Fax |
|
| Email |
shameeshastry@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Immunohematology and Blood Transfusion, KMC Manipal Karnataka- 576104 |
|
|
Primary Sponsor
|
| Name |
MAHE PG thesis grant |
| Address |
Kasturba Medical College, Manipal, Madhav nagar, 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 Bemma Paonam |
Kasturba Medical College, Manipal |
Donor Section, Room No 5, Department of Immunohematology and Blood Transfusion
Udupi
KARNATAKA |
8259956659
abepaonam12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Voluntary Blood Donors |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
-Regular voluntary ‘O’ blood group donors residing in Udupi district, meeting the blood donation criteria.
-Donors who knows their mother’s blood group. |
|
| ExclusionCriteria |
| Details |
-Donors not willing to be part of our study.
-Donors who are sero-reactive for various infectious markers
-Donors with irregular red cell antibody in routine antibody screen
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
•Anti-A and anti-B titres among O blood group donor population.
•Prevalence of haemolysin titres among O blood group donor population.
•Factors influencing anti-A anti-B titre levels. |
Two years and two months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| •Correlation between haemolysin and titre levels of anti-A and anti-B. |
Two years and Two months |
|
|
Target Sample Size
|
Total Sample Size="380"
Sample Size from India="380"
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)
|
01/06/2021 |
| 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="2"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
ABO blood group system is one of the major blood group
systems for human blood transfusion. Blood group O red blood cells (RBCs) are
called universal red cell donor because the red cells possess no A or B
antigen, however, their serum contains anti-A and anti-B antibodies. the naturally occurring antibodies react at room temperature or lower and can be IgM class or a mixture of classes: IgM, IgG and IgA. Haemolysins are antibodies (anti-A or anti-B) capable of reacting at 37°C and causing haemolysis when plasma or platelets of O-group individuals are transfused to non-group O individuals. These group O individuals having high titres of haemolysins are called dangerous universal donors. ABO antibodies decrease by mid-life and can significantly decrease or maybe absent in adults of 65 years or above. However, the factors influencing the antibody levels are not fully known. We plan this study on ABO antibody titres among O group blood donors and the factors influencing them. |