| CTRI Number |
CTRI/2023/07/055250 [Registered on: 14/07/2023] Trial Registered Prospectively |
| Last Modified On: |
03/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A test (Monocyte Monolayer Assay) to find significance of the red cell antibody. |
|
Scientific Title of Study
|
Establishing the application of Monocyte monolayer assay
(MMA) in predicting the clinical significance of the red cell antibody. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kavya J Babu |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical Collage |
| Address |
Department of Immunohematology and Blood Transfusion,Kasturba Medical Collage ,Manipal,576104
Udupi
KARNATAKA
576104
India |
| Phone |
09495667128 |
| Fax |
|
| Email |
drkavyajbabu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shamee Shastry |
| Designation |
Head of Department |
| Affiliation |
Kasturba Medical Collage |
| Address |
Department of Immunohematology and Blood Transfusion,Kasturba Medical Collage ,Manipal,576104
Udupi
KARNATAKA
576104
India |
| Phone |
9743489837 |
| Fax |
|
| Email |
shameeshastry@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kavya J Babu |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical Collage |
| Address |
Department of Immunohematology and Blood Transfusion,Kasturba Medical Collage ,Manipal,576104
Udupi
KARNATAKA
576104
India |
| Phone |
09495667128 |
| Fax |
|
| Email |
drkavyajbabu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education,Madhav Nagar,Maniapl,Karnataka,576104 |
|
|
Primary Sponsor
|
| Name |
TERUMO PENPOL |
| Address |
BabyPS,Manager PR &CSR,Trivandrum-695010.
PL 91-471-3015-602 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Manipal Academy of Higher Education |
Manipal Academy of Higher Education,Madhav Nagar,Maniapl,Karnataka,576104 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kavya J Babu |
Kasturba Hospital |
Department of Immunohematology and Blood Transfusion,Kasturba Medical Collage ,Manipal,576104
Udupi
KARNATAKA |
09495667128
drkavyajbabu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical Collage and Kasturba Hospital Institutional Ethics Committe-2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D589||Hereditary hemolytic anemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patient with auto or allo antibodies to red cell antigen and requiring
best matched blood unit transfusion
|
|
| ExclusionCriteria |
| Details |
Patients with passively acquired antibodies
Patients having alloantibodies with known specificity where phenotype matched
blood units will be given to the patient |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Performing MMA assessing the index will help us in utilizing this test in
identifying a best matched unit that will cause no or less hemolysis compared to
transfusion of red cells based on routine serological testing |
1year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
We will be able to predict the outcome of the transfusion of antigen positive unit to
the patient with the corresponding antibodies |
1year |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
15/07/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/07/2023 |
| 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)
|
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 - NO
|
|
Brief Summary
|
Patients requiring best matched blood unit transfusion due to auto or allo antibodies based on the routine immunohematological work up performed will be included in the study after obtaining informed consent. Routine immunohematological work up includes Direct and indirect antiglobulin testing (DAT & IAT), Monospecific DAT, thermal amplitude of the antibody, as indicated). As per the departmental protocol, a crossmatch of 4-6 units of donors will be crossmatched with patient’s sample. The same donor samples will be utilized to assess the MMA index. The basic principle of the test is Monocytes, the immune cells that destroy red blood cells during an adverse transfusion reaction, are isolated and placed in a single layer on a plate in the laboratory. The donor red blood cells are mixed with the patient’s antibodies and added to the monocytes. The number of monocytes with one or more red blood cells adhered/engulfed at the end of the assay is counted and this is used to calculate a “monocyte indexâ€. |