A prospective randomized phase III clinical trial to study the effectiveness of pathogen-reduced platelet concentrates in plasma, stored for up to 7 days, and compare these with untrested platelet concentrates in plasma, stored for up to 7 days. The…
ID
Source
Brief title
Condition
- Platelet disorders
- Vascular haemorrhagic disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
bleeding
Secondary outcome
platelet increments after transfusion, including correction for the body
surface area
percentage days with bleeding
transfusion reactions
number of red cell transfusions and platelet transfusions
number of days between transfusions
percentage of patients that develop antibodies
relation between laboratory tests and clinical outcomes
clinical factors that have an interaction with blood coagulation
Background summary
A new method was developed for pathogen-reduction of platelet concentrates to
inactivate micro-organisms that might be present. Riboflavin (vitamin B2) is
added to the platelet concentrate, and then illuminated with UV-B, and is then
ready for use. There are few clinical data on these treated platelet
concentrates, and thus a clinical study is needed.
In this two-armed study, treated platelet concentrates are compared with
untreated ones. From these platelet concentrates a sample will be taken
immediately before issuing to the hospital, and various in vitro tests will be
performed to link laboratory results with clinical outcomes. another objective
is to study the possiblity that the treatment will result in less
alloimmunization, which in turn will result in fewer patients that become
unresponsive to platelet transfsions. In the hospital, the bleeding rate,
increments after transfusion, and adverse events will be compared.
Study objective
A prospective randomized phase III clinical trial to study the effectiveness of
pathogen-reduced platelet concentrates in plasma, stored for up to 7 days, and
compare these with untrested platelet concentrates in plasma, stored for up to
7 days. The primary endpoint is bleeding greater than WHO grade 2 from platelet
concentrates that were stored between 1 and 5 days.
Study design
single blinded, prospective, randomized phase III trial with 2 study arms
Intervention
one group of patients will receive platelet concentrates that have been
pathogen-reduced, the other group will receive standard (untreated) platelet
concentrates
Study burden and risks
small to none, the study closely relates to the current treatment of this
patient group
Plesmanlaan 1a
Leiden 2333BZ
NL
Plesmanlaan 1a
Leiden 2333BZ
NL
Listed location countries
Age
Inclusion criteria
* Age * 18 years.
* Expected * 2 platelet transfusion requirements.
* Having a hemato-oncological disease
Exclusion criteria
* Micro-angiopathic thrombocytopenia (TTP, HUS) and ITP
* Bleeding > grade 2 at randomization ( after treatment, the patient can be randomized in the study after 2 or more weeks after the last transfusion that was used to stop the bleeding)
* Known immunological refractoriness to platelet transfusions.
* HLA- and/or HPA-allo immunization and/or clinical relevant auto-antibodies.
* Indications to use hyper-concentrated (plasma-reduced) platelet concentrates, i.e. patients with known severe allergic reactions and documented transfusion-associated circulatory overload (TACO)
* Pregnancy (or lactating)
* Prior treatment with pathogen-reduced blood products
* Known allergy to riboflavin or its photoactive products
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT2106 |
| CCMO | NL30643.098.09 |