Aim of the study is to answer the following questions:1. Is cerebral autoregulation impaired in SCD compared to historical control groups and published standard values?2. Do patients with a high level of steady state haemolysis have a more impaired…
ID
Source
Brief title
Condition
- Haemoglobinopathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Cerebral blood flow velocity, cerebral oxygenation and cerebrovascular CO2
responsiveness (as the percentage increase in MCA Vmean per mmHg increase in
PetCO2).
Secondary outcome
Autonomic cardiovascular function (blood pressure, cardiac output and derived
parameters)testing using the Ewing*s test battery (a set of short physical
exercises: e.g. vassalva maneuver and deep breathing) is used to measure
parasympathetic heart rate control, sympathetic cardiovascular control.
Background summary
The prevalence of stroke among patients with sickle cell disease younger than
19 years of age is 8 %; the lifetime risk is 25 to 30%. Data from literature
suggest that young patients with an increased risk on intracerebral infarction
may be identified by transcranial Doppler (TCD) analysis of the middle cerebral
artery (MCA) flow velocity. Cerebral autoregulation (CA) is defined as the
intrinsic capacity to maintain cerebral blood flow more or less constant (CBF)
for a range of blood pressures. Therefore an impaired CA might be one of the
causes of stroke in sickle cell disease
Study objective
Aim of the study is to answer the following questions:
1. Is cerebral autoregulation impaired in SCD compared to historical control
groups and published standard values?
2. Do patients with a high level of steady state haemolysis have a more
impaired cerebral autoregulation than patients with a low level of steady state
haemolysis?
3. Are there other factors (disease severity, NO-bioavailability, vascular
remodeling in other organs and reticulocyte count) associated with impaired
cerebral autoregulation and can this be related to its effect on the level of
haemolysis?
Study design
In the present study, we analyze the cerebral autoregulation (with cerebral
blood flow and cerebral oxygenation as primary endpoints) in 20 sickle cell
patients with either a high level of haemolysis (n = 10) or a low grade of
haemolysis (n = 10) and this will be compared with healthy (historically)
controls. Also the autonomic cardiovascular function and cerebral reserve
capacity will be measured.
Study burden and risks
no risks
Meibergdreef 9
1100 DD Amsterdam
Nederland
Meibergdreef 9
1100 DD Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
- proven sickle cell disease
- age between 18-35
Exclusion criteria
- HbSC
- History of stroke
- Hypertension (systolic >160 mm Hg or diastolic >100 mm Hg)
- Blood transfusion in the preceding four weeks
- Sickle cell crisis in the preceding two weeks
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 | NL13786.018.06 |