Platelet activity test study

In preparation of a large clinical trial, that will evaluate the effectiveness
of different platelet products against bleeding and the prediction of bleeding
in hemato-oncology patients, an observational pilot study of bleeding episodes
in these patients has recently been approved (the BOP study, protocol number:
). A flowcytometric platelet activity test has previously been developed in the
University Medical Center Utrecht. During the clinical trial the predictive
value of this platelet activity test will be determined, for the prediction of
bleeding.

In the platelet activity test study (PATS) we aim to perform a pilot to
validate the platelet activity test for use in our laboratory and test the
logistics of sample processing, in the setting of the BOP study, before
starting the clinical trial in which we will develop our prediction models.

During vena-puncture for routine care (daily platelet counts, and platelet
counts for monitoring of transfusion success) one additional tube of blood will
be drawn (4.5 mL, into citrate). Additionally, before platelet transfusion, a
small sample will be taken from the platelet product to be transfused. These
samples will be tested in the flowcytometric platelet activity test and results
will be linked to the results from the BOP study.

No risks and negligible burden anticipated.
No direct benefits for participants, but benefits for the group of patients
could be considerable: prevention of bleeding and unnecessary transfusions in
future patients.