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

Assessment of clinical effectiveness of 3 buffy coat-derived platelet concentrates as compared to the standard 5 buffy coat-derived platelet concentrates in hemato-oncology patients - The Alphabet Study (Assessment of Buffy Coat Dosage)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON54460
Enrollment
520
Registered
2021-04-08
Start date
2021-07-22
Completion date
Unknown
Last updated
2024-04-09

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

Conditions

bloedingen bleeding hemorrhage

Interventions

Patients in the study group will be treated with platelet concentrates prepared from 3 buffy coats, patients in the control group will be treated with standard platelet concentrates from 5 buffy coa

Sponsors

HagaZiekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Hemato-oncologic disease Expected to receive at least two platelet transfusions

Exclusion criteria

Exclusion criteria: Known immunologic refractoriness to platelets

Design outcomes

Primary

MeasureTime frame
Percentage of days with a grade 1b+2 bleed.

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 - proteomics analysis (only in a selected group of AML patients in the Haga hospital) - cost benefit analysis

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)