| CTRI Number |
CTRI/2025/06/089051 [Registered on: 18/06/2025] Trial Registered Prospectively |
| Last Modified On: |
13/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
In-vitro study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To test the efficacy of a biocompatible chemical in masking antigens that may be clinically significant in causing untoward transfusion reactions, present on red blood cells. |
|
Scientific Title of Study
|
Establishing the efficacy of masking the clinically significant blood group antigens on human RBCs by a biocompatible material |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bismita BIswabandini |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Immunohematology and Blood Transfusion,
Kasturba Medical College,
Manipal
Room 927, NIH-A BLOCK,
MAHE,
Madhav Nagar,
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8974522325 |
| Fax |
|
| Email |
bismita.kmcmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
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 |
shamee.girish@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Bismita BIswabandini |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Immunohematology and Blood Transfusion,
Kasturba Medical College,
Manipal
Room 927, NIH-A BLOCK,
MAHE,
Madhav Nagar,
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8974522325 |
| Fax |
|
| Email |
bismita.kmcmpl2023@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Industrial Grant
TERUMO PENPOL PRIVATE LTD. , Bhadra Towers , TC29/2923, Cotton Hill Road, Vazhuthacaud, Post.Thiruvananthapuram-695014,India Email - penpol.info@terumobct.com |
|
|
Primary Sponsor
|
| Name |
TERUMO PENPOL |
| Address |
TERUMO PENPOL PRIVATE LTD.
BHADRA TOWERS, TC 29/2923 , Cotton Hill Road ,
Vazhuthacaud,
Thycaud Post
Thiruvananthapuram ,
Kerala |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Bismita |
Kasturba Hospital ,Manipal |
Department of Immunohematology and Blood Transfusion, NEW EMERGENCY BLOCK
Udupi
KARNATAKA |
08974522325
bismita.kmcmpl2023@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Hospital, MAHE, Manipal. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy human volunteers qualifying as blood donors |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
RBC samples from healthy non remunerated voluntary blood donors. |
|
| ExclusionCriteria |
| Details |
RBC samples that are reactive for Transfusion Transmitted Infections or positive for Direct Coombs Test will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| • The study design will aid in determining the optimal concentration of bio compatible material which can effectively mask red cell antigen. • The red cells post coating should retain their structure and functionality. |
Baseline , 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/07/2025 |
| 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)
|
Not Applicable |
| 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
|
Red blood cells membrane has multiple clinically significant antigens. These antigens when present in donor sample may have unwanted immune reactions with recipient serum antibodies if present and cause agglutination/hemolysis. To overcome this unwarranted clinical scenario, we can immune camouflage these antigens by biocompatible chemical, thereby reducing transfusion reactions. PEG is our choice of this material. In aqueous solution each PEG molecule is surrounded by a hydration sphere. Hence a PEG coated RBC membrane will attract water molecules and this hydration shell shall block antibody from reaching its specific antigen, hence masking it. The study will be conducted with a collaboration between the Department of Immunohaemotology and Blood Transfusion and Department of Pharmaceutical Sciences and after approval from the Institutional Ethics Committee. Samples from healthy blood donor will be considered for the study. We will then proceed to confirm blood grouping by both forward and reverse typing methods. During routine immunohematological work up, DAT positive and Mixed Field reactivity samples will not be included |