A comparison of human leucocyte antigens (HLA) epitope-matched with standard HLA-matched platelet transfusions in raising the platelet count increment in alloimmunised thrombocytopenic patients with aplastic anaemia or low risk myelodysplastic syndrome

A comparison of HLA epitope-matched with standard HLA-matched platelet transfusions in raising the platelet count increment in alloimmunised thrombocytopenic patients with aplastic anaemia or low risk myelodysplastic syndrome: a double-blind randomised crossover superiority trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN23996532

Enrollment

Registered

2012-10-04

Start date

2012-06-01

Completion date

Unknown

Last updated

2021-02-01

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

Conditions

Topic: Blood

Interventions

Patients will receive one study platelet transfusion eight times, on eight separate occasions. Four of the platelet bags will be chosen using the standard method of HLA matching and four will be chose

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 16 years or older 2. Patients with aplastic anaemia or low-risk myelodysplastic syndrome 3. Patients who do not benefit from random (non-selected) donor platelet transfusions 4. Patients who require regular platelet transfusions according to local and British Committee for Standards in Haematology (BCSH) guidelines 5. Patients with evidence of HLA antibody(ies) 6. Patients that are expected to require multiple HLA selected prophylactic platelet transfusions

Exclusion criteria

Exclusion criteria: 1. Patients with significant and palpable splenomegaly (enlargement of the spleen) 2. Patients who do not have serum HLA antibodies 3. Patients receiving anti-thymocyte globulin (ATG) treatment, specifically for the 5 days of ATG treatment and for the 14 days after ATG treatment. Once recovered from the treatment, the patient would be eligible to participate in the trial. 4. Patients who have previously participated in this study 5. Women who are pregnant or lactating 6. Patients unable to give written informed consent or comply with the protocol

Design outcomes

Primary

Measure	Time frame
The rise in platelet count after transfusion measured one hour after transfusion	—

Secondary

Measure	Time frame
1. Assessment of bleeding before and after platelet transfusion before transfusion and for 3 days after transfusion 2. Interval between platelet transfusions - The interval between the beginning of the trial transfusion until the next trial transfusion 3. Matched grade for standard HLA matched platelets 4. Number of epitope mismatches for epitope matched platelets 5. Reactions to trial platelets within 24 hours of transfusion 6. Rise in platelet count 24 hours after transfusion 7. Rise in platelet count after transfusion taking into account the platelet dose and patient body size at 1 and 24 hours	—

Measure

Time frame

1. Assessment of bleeding before and after platelet transfusion before transfusion and for 3 days after transfusion 2. Interval between platelet transfusions - The interval between the beginning of the trial transfusion until the next trial transfusion 3. Matched grade for standard HLA matched platelets 4. Number of epitope mismatches for epitope matched platelets 5. Reactions to trial platelets within 24 hours of transfusion 6. Rise in platelet count 24 hours after transfusion 7. Rise in platelet count after transfusion taking into account the platelet dose and patient body size at 1 and 24 hours

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 17, 2026