Comparison of the Impact of Different Suspension Mediums... | NCT07054372

Studies
Comparison of the Impact of Different Suspension Mediums on ABO Antibody Titres.

NCT07054372

Sponsor

Institute of Liver and Biliary Sciences, India

Status

Completed

Last Update Posted

Jul 8, 2025Actual

Enrollment

200Actual

Phase

Not provided

Conditions

Healthy Blood Donor

Interventions

Titres on conventional test tube method with different diluent

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2024Actual

Primary Completion Date

Nov 30, 2024Actual

Completion Date

Nov 30, 2024Actual

First Submitted Date

Jun 27, 2025

First Submission Date that Met QC Criteria

Jun 27, 2025

First Posted Date

Jul 8, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 27, 2025

Last Update Posted Date

Jul 8, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy Blood Donor		Healthy Blood Donor	Diagnostic Test: Titres on conventional test tube method with different diluent

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Titres on conventional test tube method with different diluent	Diagnostic Test	Titres on conventional test tube method with different diluent	Healthy Blood Donor

Measure	Description	Time Frame
Comparison of the ABO Antibody Titres.		Day 0

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Healthy Blood Donor.

Exclusion Criteria:

- Samples from female donors, those with irregular antibodies and reactive to transfusion-transmissible infections on routine testing, were excluded.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Healthy Blood Donor.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dr Meenu Bajpai, MD	Institute of Liver and Biliary Sciences	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute of Liver and Biliary Sciences		New Delhi	National Capital Territory of Delhi	110070	India

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided