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…
ID
Source
Brief title
Condition
- Platelet disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Platelet recovery in the study groups should be *67% of platelets in plasma
stored for 2-3 days.
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.
Secondary Objective(s):
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).
Background 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.
Study objective
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.
Study design
The recovery and survival of these platelets will be determined in patients
with acute leukemia or MDS. Platelet concentrates in plasma and stored for 2-3
or 6-7 days; or made with one of the PASs mentioned above, will be administered
to the patient if the transfusion trigger is met. Donor platelets have HLA
antigens that are usually different from the patient*s platelets, and the
various populations can be tracked using fluorescent-labeled anti HLA
antibodies, with subsequent detection using flow cytometry. Based on a 60%
recovery after transfusion for *fresh* platelets, an absolute allowed
difference of 20%, a standard deviation of 10%, with alpha=0.05 and a power of
90%, 7 transfusions for each of the study conditions need to be performed in
consenting non-alloimmunized thrombocytopenic patients.
In addition, recovery and survival will be determined using differences in the
highly variable regions of mitochondrial DNA. Differences will be determined
with a Ligation Detection Reaction.
Intervention
The standard of care in the Netherlands is 7 day storage of platelet
concentrates in plasma or in Intersol. The intervention is that patients will
receive in newer PASs, stored for 6-7 days.
Study burden and risks
Patients will undergo up to 5 blood samplings in addition to regular sampling.
Preferably, sampling is performed using a katheter, which is usually present in
this patient group. Patients may need to be transfused at a higher platelet
count as the current trigger (a platelet concentration below 10 x10^9/L), up to
a trigger of 20 x10^9/L. Under the worst circumstances the recovery and
survival of the platelets are zero, thus the patients will require a new
transfusion. This potentially increases donor exposure of the patient. The only
expected immediate benefit is a lower risk of allergic reactions. The risk of a
study transfusion should be weighed in the light of all the transfusions a
particular patient will receive.
Plesmanlaan 125
Amsterdam 1066 CX
NL
Plesmanlaan 125
Amsterdam 1066 CX
NL
Listed location countries
Age
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 (myelodysplastic syndrome).
Exclusion criteria
* Micro-angiopathic thrombocytopenia (TTP, HUS) and ITP.
* Bleeding greater than grade 2 at time of inclusion. If the patient has been treated for the bleeding complication, the patient can be included in the study 1 week after the last intervention that was used to stop the bleeding. Pre-existing skin bleeds (bruises) greater than 2.5 cm will not be included in judgment of the WHO bleeding grade at the time of assessment of eligibility or at the time of inclusion.
* Transfusions within 1 week after ATG.
* Known immunological refractoriness to platelet transfusions. Refractoriness may be known to the treating physician by either HLA/HPA antibody screening, or by earlier poor responses to platelet responses.
* HLA- and/or HPA-allo immunization and/or clinical relevant auto-antibodies.
* Indications to use platelet concentrates with specific characteristics/modifications (for example, volume reduced platelets, HLA matched platelets, etc).
* Pregnancy (or lactating).
Design
Recruitment
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL49911.098.14 |
| OMON | NL-OMON24088 |