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A study to assess the transfusion of leukoreduced blood units in thalassemia patients.

A study to assess the transfusion efficacy of leukoreduced packed red blood cells prepared by two different methods in thalassemia major patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/04/042168
Enrollment
80
Registered
2022-04-26
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: D561- Beta thalassemia

Interventions

Intervention1: Transfusion of NLPRBC: Transfusion(by intravenous route) of leukoreduced packed red blood cells prepared by a new method involving filtration of whole blood followed by separation into

Sponsors

PGIMER Chandigarh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adults 2. Transfusion-dependent thalassemia major patients 3. Receiving transfusions exclusively at the PGIMER, Chandigarh

Exclusion criteria

Exclusion criteria: 1. Minors (age 2. Red cell autoantibodies in the patient 3. Massive splenomegaly 4. Any bleeding episode in the last 24 hours 5. Transfusion of any other blood product during the same episode 6. Pregnancy 7. Patients receiving washed red blood cells 8. Active ongoing fever or documented infection 9. Increased annual blood transfusion requirement ( >200-220 mL/kg/year)

Design outcomes

Secondary

MeasureTime frame
Effect on transfusion interval, number of units consumedTimepoint: 3 months—

Primary

MeasureTime frame
To detect a clinically significant difference of 0.3 g/dL rise in the hemoglobin increment between the two groups pf patients transfused with leukoreduced packed red blood cells prepared by the two different methods.Timepoint: 3 months—

Countries

India

Contacts

Public ContactAdhikarimayum Arunkumari

PGIMER, Chandigarh

ashishjain16@gmail.com7087009491

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026