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Assessment of Buffy Coat Dosage

Assessment of clinical effectiveness of 3 buffy coat-derived platelet concentrates as compared to the standard 5 buffy coar-derived platelet concentrates in hemato-oncology patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON23468
Enrollment
520
Registered
2021-01-19
Start date
2021-03-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Hemato-oncologic

Interventions

The study group will receive 3-BC-PCs, the control group 5-BC-PCs.

Sponsors

HagaZiekenhuis
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Age = 18 years. • Having a hemato-oncologic disease. • Expected = 2 platelet transfusion requirements during current hospitalization. • Signed informed consent.

Exclusion criteria

Exclusion criteria: • Known immunological refractoriness to platelet transfusions. • HLA- and/or HPA-alloimmunization and/or clinical relevant auto-antibodies. • Indications to use HLA-typed platelet concentrates. • Indications to use hyper-concentrated (plasma-reduced) platelet concentrates, for example patients with known severe allergic reactions or transfusion-associated circulatory overload (TACO). • Micro-angiopathic thrombocytopenia (TTP, HUS) and ITP.

Design outcomes

Primary

MeasureTime frame
Percentage of days with grade 1b+2 bleeding according to the Bleeding Severity Measurement Scale (BSMS) as primary endpoint.

Secondary

MeasureTime frame
• total number of platelets received • total number of individual buffy coats received • the 1 and 24 hour CI • the 1 and 24 hour CCI • percentage of patients with at least one bleeding grade 1b+2 according to the BSMS • percentage of patients and percentage of days per patient with at least one = clinically relevant minor bleeding grade according to the ISTH bleeding scale • rate of HLA alloimmunization • adverse transfusion reactions • platelet transfusion interval • total number of platelet transfusions • total number of red cell and plasma transfusions • association between albumin/creatinine in urine and/or CRP and clinically relevant bleeding grades according to the BSMS • cost benefit analysis

Contacts

Public ContactPieter van der Meer

HagaZiekenhuis

p.f.vandermeer@hagaziekenhuis.nl0612983735

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)