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Recovery and survival of platelets in additive solution


- candidate number21854
- NTR NumberNTR5146
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-mrt-2015
- Secondary IDsNL49911.098.14 
- Public TitleRecovery and survival of platelets in additive solution
- Scientific TitleRecovery and survival of platelet concentrates in plasma and in 3 additive solutions
- ACRONYMRaSPAS study
- hypothesisThe recovery and survival of platelets stored in 3 different platelet additive solutions for 7 days is non inferior to the recovery and survival of platelets stored in plasma for 7 days
- Healt Condition(s) or Problem(s) studiedHemato-oncological patients, Myelodysplastic syndrome (MDS), Platelet aggregation, Fresh frozen plasma, Survival
- 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 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).
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 4-mei-2015
- planned closingdate8-mei-2017
- Target number of participants0
- InterventionsThe 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 concentrates in newer PASs, stored for 6-7 days.
- Primary outcomePlatelet recovery in the study groups should be ≥67% of platelets in plasma stored for 2-3 days.
- Secondary outcomeo 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).
- Timepoints
- Trial web site
- status[default]
- CONTACT FOR PUBLIC QUERIESDr. P.F. van der Meer
- CONTACT for SCIENTIFIC QUERIESDr. P.F. van der Meer
- Sponsor/Initiator Sanquin Blood Bank (Stichting Sanquin Bloedvoorziening)
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summaryPlatelets in plasma can be stored for at least 7 days under blood bank conditions with maintenance of in vitro and in vivo quality. The use of platelet additive solution (PAS) as replacement for storage in plasma is attractive, as PASs are associated with about 50% fewer allergic reactions post transfusion. Further, there is evidence that the newer generation PASs have much better capability of maintaining the platelet quality, and are thought to be at least equal to that in plasma. A number of alternative PASs are available (for example Composol, Intersol and SSP+); not only do they preserve the platelet function better, they also provide a margin in case safety technologies (like pathogen reduction methods) are applied that would potentially reduce platelet shelf life. The objectives of this study is to determine the recovery and survival of platelet concentrates; in the first phase, a comparison will be made for platelet concentrates in plasma stored for 2-3 days versus those stored for 6-7 days; in the second phase, platelet concentrates stored for 6-7 days in Composol, Intersol and SSP+ (in about a 35%-plasma/65%-PAS ratio) will be evaluated.
- Main changes (audit trail)
- RECORD25-mrt-2015 - 21-mei-2015


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