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

Withdrawn

Conditions: bleeding
Thrombocytopenia
10035534

Registration Number: NL-OMON41726

Lead Sponsor: Sanquin Bloedbank

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 25

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).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Platelet recovery in the study groups should be *67% of platelets in plasma<br /><br>stored for 2-3 days. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>o Phase 2: To determine the recovery and survival of platelet concentrates in<br /><br>Composol, Intersol and SSP+ (in a ±35%-plasma/±65%-PAS ratio) stored for 6-7<br /><br>days.<br /><br>Secondary Objective(s):<br /><br>o To determine survival of platelet concentrates, stored for 2-3 (plasma only)<br /><br>or 6-7 days in plasma, Composol, Intersol and SSP+ (in a ±35%-plasma/±65%-PAS<br /><br>ratio).<br /><br>o To determine the 1-h and 24-h count increment and corrected count increment<br /><br>of platelet concentrates, stored for 2-3 (plasma only) or 6-7 days in plasma,<br /><br>or in Composol, Intersol and SSP+ (in a ±35%-plasma/±65%-PAS ratio).</p><br>