Healthy Blood DonorNCT07054372
Comparison of the Impact of Different Suspension Mediums on ABO Antibody Titres.
An observational study of Healthy Blood Donor, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
Accurate estimation of ABO antibody titres is vital in Transfusion Medicine due to their involvement in hemolytic transfusion reactions, hemolytic disease of the fetus and newborn, and solid-organ transplant rejection. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Blood Donor
- What is being tested?
- Titres on conventional test tube method with different diluent
- How many people
- 200 participants
- Where
- 1 siteIndia
- Study dates
- 1 Aug 2024to 30 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy Blood Donor.
Who may be able to join
- Healthy Blood Donor.
Who cannot join
- Samples from female donors, those with irregular antibodies and reactive to transfusion-transmissible infections on routine testing, were excluded.
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
About this study
Accurate estimation of ABO antibody titres is vital in Transfusion Medicine due to their involvement in hemolytic transfusion reactions, hemolytic disease of the fetus and newborn, and solid-organ transplant rejection. Although the conventional tube technique (CTT) remains the gold standard, its standardization is challenging, partly influenced by the choice of diluents. This study aimed to compare commonly used diluents in ABO antibody titration via CTT and analyze the resulting titre variations.
- Conditions
- Healthy Blood Donor
- Being tested
- Titres on conventional test tube method with different diluent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Titres on conventional test tube method with different diluentDiagnostic test
Titres on conventional test tube method with different diluent
| Study group | Role | What they receive |
|---|---|---|
| Healthy Blood Donor | Healthy Blood Donor Receives: Diagnostic Test: Titres on conventional test tube method with different diluent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the ABO Antibody Titres.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start1 Aug 2024
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Blood DonorStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Meenu Bajpai, MD, Study director, Institute of Liver and Biliary Sciences, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07054372
- Sponsor's protocol ID
- ILBS-Titres-01
- Status last verified
- Jun 2025
- First submitted
- 27 Jun 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Impact of Different Suspension Mediums on ABO Antibody Titres.
- ClinicalTrials.gov ID
- NCT07054372
- Acronym / sponsor ID
- ILBS-Titres-01
- Conditions
- Healthy Blood Donor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 8 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Accurate estimation of ABO antibody titres is vital in Transfusion Medicine due to their involvement in hemolytic transfusion reactions, hemolytic disease of the fetus and newborn, and solid-organ transplant rejection. Although the conventional tube technique (CTT) remains the gold standard, its standardization is challenging, partly influenced by the choice of diluents. This study aimed to compare commonly used diluents in ABO antibody titration via CTT and analyze the resulting titre variations.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Blood Donor | – | Diagnostic Test: Titres on conventional test tube method with different diluentHealthy Blood Donor |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy Blood Donor.
Key inclusion criteria (1 listed)
- Healthy Blood Donor.
Key exclusion criteria (1 listed)
- Samples from female donors, those with irregular antibodies and reactive to transfusion-transmissible infections on routine testing, were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Titres on conventional test tube method with different diluentTitres on conventional test tube method with different diluent | Diagnostic test | Healthy Blood Donor |
Primary outcome
Comparison of the ABO Antibody Titres.
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Meenu Bajpai, MD study director
Institute of Liver and Biliary Sciences, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Blood Donor, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the ABO Antibody Titres. (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.