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Recovery and survival of platelets in additive solution

Recovery and survival of platelet concentrates in plasma and in 3 additive solutions

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24088
Enrollment
Unknown
Registered
2015-03-25
Start date
2015-05-04
Completion date
Unknown
Last updated
2024-06-11

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

Conditions

Hemato oncologic disease

Interventions

The standard of care in the Netherlands is 7 day storage of platelet concentrates in plasma or in Intersol platelet additive solution (PAS). The intervention is that patients will receive platelet

Sponsors

Sanquin Bloedbank
Lead Sponsor

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

MeasureTime frame
Platelet recovery in the study groups should be ≥67% of platelets in plasma stored for 2-3 days.

Secondary

MeasureTime 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

Public ContactP.F. van der Meer

Sanquin Bloedbank - Product en Proces Onwikkeling

p.vandermeer@sanquin.nl020 5123818

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)