The purpose of the study is to provide a first assessment of safety, tolerability and efficacy of Ir-CPI, administered on top of standard-of-care, on secondary brain injury in patients with spontaneous intracerebral haemorrhage.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
23
Participants receive a single intravenous dose of Ir-CPI during 48 hours
HUB Erasme
Brussels, Brussels Capital, Belgium
UCL St Luc
Brussels, Brussels Capital, Belgium
UZ Brussel
Brussels, Brussels Capital, Belgium
UZ Gent
Ghent, East Flanders, Belgium
Number of Participants with Adverse Events
Time frame: 360 days post-randomization
Incidence of abnormalities in physical examination
A complete physical examination will include, at a minimum, assessments of the cardiovascular, respiratory, gastrointestinal, dermatological, neurological (including basic neurological testing for isocoria, light reflexes, gait and balance), musculoskeletal and lymphatic systems, in addition to head, eyes, ears, nose, throat, and neck.
Time frame: 7 days post-randomization
Change from baseline in HR interval
Measured by standard 12-lead ECG
Time frame: 7 days post-randomization
Change from baseline in PR interval
Measured by standard 12-lead ECG
Time frame: 7 days post-randomization
Change from baseline in QRS duration
Measured by standard 12-lead ECG
Time frame: 7 days post-randomization
Change from baseline in QRS axis
Measured by standard 12-lead ECG
Time frame: 7 days post-randomization
Change from baseline in QT interval
Measured by standard 12-lead ECG. Two corrections of the QT interval will be investigated: Fridericia's correction (QTcF) and Bazett's correction (QTcB)
Time frame: 7 days post-randomization
Change from baseline in blood pressure
Blood pressure (systolic and diastolic) is measured using an automatic device
Time frame: 7 days post-randomization
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UZ Leuven
Leuven, Flemish Brabant, Belgium
CHU Ambroise Paré
Mons, Hainaut, Belgium
AZ Sint-Jan
Bruges, West Flanders, Belgium
AZ Groeninge
Kortrijk, West Flanders, Belgium
AZ Damiaan
Ostend, West Flanders, Belgium
Clinique CHC MontLégia
Liège, Belgium
Change from baseline in heart rate
Heart rate is measured using an automatic device
Time frame: 7 days post-randomization
Change from baseline in body temperature
Measurement of tympanic temperature
Time frame: 7 days post-randomization
Change from baseline in perihematomal oedema (PHO) and haemorrhage volumes
CT scans will be acquired by volumetric CT acquisition with reconstructions in 3 planes, in order to assess hematoma volume and perihematomal volume. Assessment of hematoma expansion will be performed by comparing follow-up CT scans with baseline CT.
Time frame: 10 days post-randomization
Measurement of the effect of Ir-CPI on the activated Partial Thromboplastin Time (aPTT)
Activated partial thromboplastin time (aPTT) will be used as a pharmacodynamic marker
Time frame: 7 days post-randomization
Measurement of the effect of Ir-CPI on the inhibition of Factor XI (FXI) and Factor XII (FXII) procoagulant activities
The inhibition of Factor XI (FXI) and Factor XII (FXII) procoagulant activities will be assessed to support the aPTT dynamics
Time frame: 7 days post-randomization
Change from baseline in Ir-CPI plasma concentrations
Time frame: 7 days post-randomization