To further investigate the pathogenesis of DCI and its relation to gender, decreased fibrinolysis, increased coagulation, and hormonal factors in order to eventually pave the way for new treatment options.
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The relationship of delayed cerebral ischemia occurence with blood coagulation
parameters and sex hormones:
-ESR, Blood count, Glucose, Kreatinine, Calcium, Albumin, Magnesium, CRP
-D-dimer, Von Willebrand factor, ADAMTS13, Prothrombin fragment 1 and 2,
Endogenious thrombin potential
-17-beta-estradiol, Progesterone, Testosterone, Dihydrotestosterone
Secondary outcome
1) To evaluate whether occurrence of DCI after SAH is gender-specific
2) To study imaging of patient with SAH in order to evaluate whether patients
with and without DCI develop cerebral infarction.
3) To assess whether the glycocalyx is affected in SAH patients and is related
to its severity and the development of DCI.
4) To evaluate whether glycocalyx perturbation is associated with vasomotion
changes as non-invasively assessed by finger arterial waveform registration, in
SAH patients.
Background summary
Delayed cerebral ischemia (DCI) is a complication of subarachnoid haemorrhage
(SAH), a devastating form of stroke mostly affecting young adults. The
pathogenesis of DCI is still not well understood, making treatment options
difficult. While it was thought before that it was caused by vasospasm of the
cerebral vasculature, more recent studies have shown a role for microthrombus
formation by decreased fibrinolysis, an increase in coagulation and changes in
endothelial function. Moreover recent work has revealed that treatment of DCI
after SAH to only be effective in female patients, suggesting a role for gender
in the pathogenesis of DCI.
Study objective
To further investigate the pathogenesis of DCI and its relation to gender,
decreased fibrinolysis, increased coagulation, and hormonal factors in order to
eventually pave the way for new treatment options.
Study design
prospective observational cohort study
Study burden and risks
Patients will undergo blood sampling at baseline and at 6 fixed time points
during hospital stay. Each time 30 mlof blood will be drawn. We will make use
of existing catheters and lines for drawing of blood. When needed blood will be
collected by venous puncture, which has been shown to be safe. We expect the
risk to the patient from the sampling of blood to be negligible. Additionally
in a subgroup of 40 patients the peripheral and central hemodynamics will be
assessed using continuous finger arterial pressure (FinAp) waveform
registration by Nexfin. These patients will additionally be asked to give
consent to a glycocalyx volume m,easurement with Sideview Dark Field (SDF)
imaging (a camera under the tonque). Both of these measuring thechniques are
not harmfull to the patient. We will also have to include incapacitated
patients, because most patients with SAH are acutely ill and will not be able
to give consent themselves. It would not be possible to investigate this
disease without bias if we were to exclude incapacitated patients.
Meibergdreef 15
Amsterdam 1105AZ
NL
Meibergdreef 15
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
Patients with suspected aneurysmal subrarachnoid haemorrhage
Exclusion criteria
1) Under 18 years of age
2) Presentation >72 hours after initial ictus of haemorrhage
3) If death appears imminent
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 | NL39814.018.12 |