| CTRI Number |
CTRI/2023/06/053798 [Registered on: 13/06/2023] Trial Registered Prospectively |
| Last Modified On: |
18/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Prospective study for determining the prevalence of causes of ABO blood group discrepancies and to establish a clinical classification in a tertiary care transfusion cente |
|
Scientific Title of Study
|
Prospective study for determining the prevalence of causes of ABO blood group discrepancies and to
establish a clinical classification in a tertiary care transfusion center |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sumankita Nanduri |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Department of Immunohematology and Blood transfusion, Kasturba Medical College, Manipal
8019011512
nanduri1512@gmail.com
Udupi
KARNATAKA
576104
India |
| Phone |
8019011512 |
| Fax |
|
| Email |
sumankita.kmcmpl2022@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shamee Shastry |
| Designation |
HOD and Professor of Department of IHBT |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Department of Immunohematology and Blood transfusion, Kasturba Medical College, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9743489837 |
| Fax |
|
| Email |
shamee.girish@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Sumankita Nanduri |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Department of Immunohematology and Blood transfusion, Kasturba Medical College, Manipal
8019011512
nanduri1512@gmail.com
KARNATAKA
576104
India |
| Phone |
8019011512 |
| Fax |
|
| Email |
sumankita.kmcmpl2022@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College Manipal Academy of Higher Education |
|
|
Primary Sponsor
|
| Name |
MAHE Thesis Grant |
| Address |
Kasturba Medical College MAHE Manipal Udupi Karnataka 576104 |
| 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 |
| Sumankita |
Kasturba Hospital Manipal |
Department of Immunohematology and Blood banking Kasturba Hospital Manipal 576104
Udupi
KARNATAKA |
8019011512
sumankita.kmcmpl2022@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee of Kasturba Medical College and Kasturba Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
blood grouping |
| Patients |
(1) ICD-10 Condition: Z671||Type A blood, (2) ICD-10 Condition: Z672||Type B blood, (3) ICD-10 Condition: Z673||Type AB blood, (4) ICD-10 Condition: Z674||Type O blood, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All samples from regular voluntary blood donors that meet the blood donation criteria in Kasturba hospital, Manipal. All the patient samples sent for blood grouping to Department of IHBT from Kasturba Hospital, Manipal |
|
| ExclusionCriteria |
| Details |
Patient samples referred from outside hospitals will be excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. The prevalence of ABO discrepancies and common causes will be determined.
2. Newer method for classification of ABO discrepancy
|
At 12 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Molecular resolution of blood grouping discrepancies |
At 12 months |
|
|
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)
|
22/06/2023 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
1) ABO
grouping is an essential step of immunohematology workup. Matching of blood
group antigens is important while providing transfusion support, in transplantations
to decrease the chances of graft rejection. Timely resolution of ABO
discrepancy is an important step of patient management.
ABO
discrepancy is when the reactions in forward and reverse grouping do not align
with each other, usually due to unexpected positive or negative reactions in
either. This can be due to intrinsic problems with either the antibodies or
RBCs in the sample and also due to technical errors.
Based
on the traditional way of classification of ABO discrepancy, there are four
types of discrepancies. Type 1 has unexpected reactions in reverse grouping.
Type 2 has unexpected reactions in forward grouping. Type 3 has unexpected
reactions due to rouleaux formation caused by protein abnormalities. Type 4 is
due to miscellaneous causes.
Blood
grouping is an essential step to be done on both donor’s and patient’s blood
before issuing blood to the patient. Discrepancies must be resolved first
before reporting the blood groups to avoid cross-match incompatibility.
Incompatibility between the donor’s and patient’s blood can lead to severe transfusion
reactions which at times can be fatal. Most discrepancies can be resolved by
serological methods. Discrepancies not resolved as so are to be resolved using
molecular genotyping methods.
It
is important to study the incidence and prevalence of ABO discrepancies and
their various causes. The study by Shanti et al in a tertiary care center in
central south India noted ABO discrepancies in 4.75% of total groupings. These
were due to subgroup A (81%), autoantibodies (14.5%) (out of which 37% were due
to cold autoantibodies and the rest due to warm and mixed type), alloantibodies
(2.56%), Bombay phenotype (1.2%), ParaBombay (0.6%) and
multiple myeloma and heparin therapy (1.4%).
With
this background, we aimed to determine the causes of ABO blood grouping discrepancy
at our center. The main objective of the study is to develop a clinically
relevant method of classification of ABO discrepancies and to assess the
appropriate resolution techniques for those categories. |