| CTRI Number |
CTRI/2024/04/066548 [Registered on: 30/04/2024] Trial Registered Prospectively |
| Last Modified On: |
25/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Prevalence of anti-red blood cell alloantibodies in thalassemia patients receiving regular blood transfusions |
|
Scientific Title of Study
|
Prevalence of Alloantibodies in Transfusion dependent Thalassemia patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sunil Kumar |
| Designation |
Specialist Grade 1 and Head of Department |
| Affiliation |
Lok Nayak Hospital |
| Address |
Department of Blood bank,
Lok Nayak Hospital, New Delhi
Central
DELHI
110002
India |
| Phone |
9873617572 |
| Fax |
|
| Email |
drsunilesi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Neha Parashar |
| Designation |
Senior Resident |
| Affiliation |
Lok Nayak Hospital |
| Address |
Department of Clinical Pathology,Lok Nayak Hospital, New Delhi
Central
DELHI
110002
India |
| Phone |
9910306518 |
| Fax |
|
| Email |
nehaparashar127@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sunil Kumar |
| Designation |
Specialist Grade 1 and Head of Department |
| Affiliation |
Lok Nayak Hospital |
| Address |
Department of Blood Bank, Lok Nayak Hospital, New Delhi
Central
DELHI
110002
India |
| Phone |
9873617572 |
| Fax |
|
| Email |
drsunilesi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Blood Bank, Lok Nayak Hospital, New Delhi 110002 |
|
|
Primary Sponsor
|
| Name |
Sunil Kumar |
| Address |
Department of Blood Bank, Lok Nayak Hospital, New Delhi |
| Type of Sponsor |
Other [Self] |
|
|
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 Sunil Kumar |
Lok Nayak Hospital, New Delhi 110002 |
Room no.107, Blood Bank, Accident and Emergency Block, Lok Nayak Hospital, Jawaharlal Nehru Marg, New Delhi 110002
Central
DELHI |
9873617572
drsunilesi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maulana Azad Medical College and associated Lok Nayak Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D569||Thalassemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with thalassemia dependent on regular blood transfusion. |
|
| ExclusionCriteria |
| Details |
Patients diagnosed with thalassemia not dependent on regular blood transfusion. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the frequency of alloimmunization in patients diagnosed with thalassemia dependent on regular blood transfusions. |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To correlate the frequency of alloimmunization in transfusion dependent thalassemia patients with the red blood cell requirement |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
10/05/2024 |
| 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="1"
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
|
The present study is a retrospective study where secondary data obtained from previous laboratory records of patients diagnosed with thalassemia, receiving regular blood transfusions at Lok Nayak Hospital during the study period from 1 November 2023- 31 January 2024 will be analysed. The patients had been admitted for receiving blood transfusion. Blood samples had been collected immediately prior to the transfusion. These samples had been subjected to antibody screening. Plasma samples had been screened for alloantibodies by the indirect antiglobulin test utilizing commercial three cell panel, Diacell I+II+III. Plasma samples that had exhibited a positive result with ID-Diacell antibody screen underwent antibody identification utilizing an extended commercial 11-cell identification panel. |