|- candidate number||21854|
|- NTR Number||NTR5146|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||25-mrt-2015|
|- Secondary IDs||NL49911.098.14 |
|- Public Title||Recovery and survival of platelets in additive solution|
|- Scientific Title||Recovery and survival of platelet concentrates in plasma and in 3 additive solutions|
|- ACRONYM||RaSPAS study|
|- hypothesis||The 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) studied||Hemato-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 received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||4-mei-2015|
|- planned closingdate||8-mei-2017|
|- Target number of participants||0|
|- 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 concentrates in newer PASs, stored for 6-7 days.|
|- Primary outcome||Platelet recovery in the study groups should be ≥67% of platelets in plasma stored for 2-3
|- Secondary outcome||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).
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||Dr. P.F. van der Meer|
|- CONTACT for SCIENTIFIC QUERIES||Dr. P.F. van der Meer|
|- Sponsor/Initiator ||Sanquin Blood Bank (Stichting Sanquin Bloedvoorziening)|
(Source(s) of Monetary or Material Support)
|- Brief summary||Platelets 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
|- Main changes (audit trail)|
|- RECORD||25-mrt-2015 - 21-mei-2015|