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Platelet HLA epitope matching strategy in patients with immune PTR: a non-inferiority randomized control trial

Platelet HLA epitope matching strategy in patients with immune PTR: a non-inferiority randomized controll trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064128
Enrollment
Unknown
Registered
2022-09-27
Start date
2022-09-28
Completion date
Unknown
Last updated
2023-04-17

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

Conditions

Platelet transfusion refractoriness, PTR

Interventions

Test Group and Control Group:HLA Epitope matching and traditional antigen matching

Sponsors

The Shenzhen Second People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 65 Years

Inclusion criteria

Inclusion criteria: Ineffective Platelet Transfusion (PTR) means that the clinical bleeding and platelet count are not improved and obviously lower than expected after two or more ABO-identical platelet transfusions with less than 5 days preservation time. Study participants: PTR patients aged 16-65 years who were thrombocytopenia with alloimmune aplastic anemia, myelodysplastic syndrome, or acute myeloid leukemia (AML) , it was not effective for random donor platelet transfusion, and HLA antibody screening test was positive. Platelet infusions with HLA Matchmaker epitope matching (Hem) were selected using HLA Matchmaker epitope matching (especially small fragments) . Platelet transfusions of Hla epitope-matched (Hem) or traditional HLA antigen-matched platelets were provided in random order per hospitalization cycle in patients with immune PTR, and the primary outcome was to observe changes in the platelet increase index (1HPCI) 1 hour after transfusion in patients with PTR.

Exclusion criteria

Exclusion criteria: 1. Patients with Splenomegaly; 2. Patients recently treated with Antithymocyte Globulin; 3. Pregnant or lactating women; 4. Patients who were unable to give informed consent or comply with the trial protocol.

Design outcomes

Primary

MeasureTime frame
PCI;

Secondary

MeasureTime frame
1 h CCI, 24 h CCI;

Countries

China

Contacts

Public ContactWu Changlin

The Shenzhen Second People's Hospital

wuchlin@126.com+86 755 83216122

Outcome results

None listed

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