Hemato oncologic disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: • Age ≥ 18 years. • Expected to require at least one platelet transfusion. • Signed informed consent. • Are hospitalized. • Clinically stable, i.e. no active bleeding, no fever, or other reasons for increased platelet consumption. • Have acute leukemia or MDS.
Exclusion criteria
Exclusion criteria: • Micro-angiopathic thrombocytopenia (TTP, HUS) and ITP. • Bleeding  grade 2 at time of inclusion. • Transfusions within 1 week after ATG • Known immunological refractoriness to platelet transfusions. • HLA- and/or HPA-allo immunization and/or clinically relevant auto-antibodies. • Indications to use platelet concentrates with specific characteristics/modifications. • Pregnancy (or lactating).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Platelet recovery in the study groups should be ≥67% of platelets in plasma stored for 2-3 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| o Phase 2: To determine the recovery and survival of platelet concentrates in Composol, Intersol and SSP+ (in a ±35%-plasma/±65%-PAS ratio) stored for 6-7 days. o To determine survival of platelet concentrates, stored for 2-3 (plasma only) or 6-7 days in plasma, Composol, Intersol and SSP+ (in a ±35%-plasma/±65%-PAS ratio). o To determine the 1-h and 24-h count increment and corrected count increment of platelet concentrates, stored for 2-3 (plasma only) or 6-7 days in plasma, or in Composol, Intersol and SSP+ (in a ±35%-plasma/±65%-PAS ratio). | — |
Contacts
Sanquin Bloedbank - Product en Proces Onwikkeling