Aim of the study is to show the feasibility of pneumatic tube transport of thrombocyte concentrates. The efficacy will be measured by thrombocyte increment (CCI) and thrombocyte funtion analysis. This shall lead to routine transportation of TC*s to…
ID
Source
Brief title
Condition
- Platelet disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Increment of transfuion after 1 and 24 hours (measured by number of
thrombocytes and corrected ammount increment-CCI)
Differences of
Mean platelet volume (MPV)
Whole blood impedance measurement (activated by ADP/TRAP/COLL/ASPI)
CD62
Microparticles
PFA-100
Thrombelastography (for fibrinolysis)
Secondary outcome
Incidence of spontaneous bleeding irrespective TC transfusion.
Background summary
Bloodproducts should be of good quality to reach optimal transfusion efficacy.
Furthermore bloodproducts are primarily given to acute bleeding patients or to
patients at high risk of bleeding. For this reason the process from decision to
transfusion should be performed as quick as possible.
In the academic medical center Maastricht there are two pneumatic systems. The
one is used for transport of specimens wheras the second is used for transport
of bloodproducts (packed cells, FFP, thrombocyte concentrates) for transfusion
purpose.
Nevertheless there is concern about potential disadvantages. The reason for
this is the high acceleration and deceleration which cause mechanical stress to
the cells. As a result there could be thrombocyte dysfunction which will be
seen in inadequate transfusion success, formation of unstable clots and even
boosted fibrinolysis. Actual research showed no consequences of pneumatic tube
transport on thrombocyte concentrates in vitro. But still there are no data on
the effects in vivo.
Study objective
Aim of the study is to show the feasibility of pneumatic tube transport of
thrombocyte concentrates. The efficacy will be measured by thrombocyte
increment (CCI) and thrombocyte funtion analysis. This shall lead to routine
transportation of TC*s to the day care center for the purpose of transfusion to
our selected population. This shall lead to more patient contentment
Study design
The study will use a Simon*s two stage design. After inclusion of 20 patients,
we will perform an interim analysis. If 16 or less patients have a good
thrombocyte increment, the study will be stopped. If this is not the case, 38
extra patients will be included (in total 58).
Study burden and risks
There will be only an interview for the informed consent. Furthermore 52.5 ml
blood (overall) will be drawn from the central venous line.
Participants will receive coffee or tea and a compensation for traveling of 20
euros.
P. Debeyelaan 25
Maastricht 6229 HX
NL
P. Debeyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
thrombocytopenia (<10 x 109/L) with an indication for prophylactic platelet
transfusion
adults
informed consent
Exclusion criteria
Infection and sepsis, active bleeding, splenomegaly
Treatment with anticoagulants (LMWH, acetylic acid, coumarines)
Thrombocyte transfusion shorter than 72 hours ago
Temperature above 37.9 degrees Celsius
Design
Recruitment
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 |
---|---|
CCMO | NL47681.068.14 |