We propose an observational clinical trial in critically ill patients to investigate the effect and duration of platelet transfusion on coagulation, including platelet function and markers of endothelial activation in critically ill patients.
ID
Source
Brief title
Condition
- Platelet disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The increase in platelet count and the effect on coagulation before and after
platelet concentrate transfusion.
Secondary outcome
Platelet increment at 2 and 4 hours
• Rotational tromboelastography (INTEM, EXTEM, FIBTEM)
• MCF, CT, CFT, α-Angle.
• Classical coagulation tests
• PT, INR, aPTT
• Fibrinogen
• D-Dimer
• Multiplate
• AUC, slope.
• Trombin-antitrombin complexes
• Trombin generation
• Endothelial activation
• Syndecan
• Fragmentocytes
Background summary
Platelet transfusion is frequently administered to critically ill patients.
However, there is a paucity of data about its effects on coagulation. Of note,
opposite to the research hypothesis, recent investigations show that platelet
transfusion is not favourable in patients with cerebral haemorrhage on
antiplatelet therapy. To address the effects and duration of platelet
transfusion on coagulation, we want to perform a thromboelastometric study in
critically ill patients, scheduled for a single platelet transfusion.
Study objective
We propose an observational clinical trial in critically ill patients to
investigate the effect and duration of platelet transfusion on coagulation,
including platelet function and markers of endothelial activation in critically
ill patients.
Study design
Single centre observational clinical trial.
Study burden and risks
Critically ill patients differ from hematological patients in both causes of
thrombocytopenia and the response to PLT transfusion. Detrimental effects of
transfusion are thought to be more extensive in critically ill patients.
Therefore, a study in this specific patient population is necessary.
Meibergdreef 9
1105 AZ Amsterdam 1100DD
NL
Meibergdreef 9
1105 AZ Amsterdam 1100DD
NL
Listed location countries
Age
Inclusion criteria
• Patients need to be admitted to the Intensive Care Unit
• The indication for 1 unit of PLT concentrate, at physician*s discretion.
• Arterial line to enable blood sampling.
Exclusion criteria
• Contra-indication for PLT transfusion, e.g. TTP.
• The use of ticagrelor or clopidogrel.
• Severe active bleeding, e.g. bleeding that leads to multiple transfusions.
• No informed consent
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 | NL63679.018.17 |