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The effect of GBT440 on cerebral perfusion and oxygenation (GBT440-MRI side study)

The effect of GBT440 on cerebral perfusion and oxygenation (GBT440-MRI side study) - GBT440-MRI side study

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON46527
Enrollment
15
Registered
2018-05-03
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sickle cell disease

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Subjects have to be included in the HOPE study (GBT440-031 - NL60453.018.17)

Exclusion criteria

Exclusion criteria: 1. Subjects who are excluded from the HOPE study (GBT440-031 - NL60453.018.17) 2. No informed consent has been given 3. Contra-indication for MRI or acetazolamide 4. Previous symptomatic stroke

Design outcomes

Primary

MeasureTime frame
In our current research we have shown that low hemoglobin levels raise resting CBF and leave patients with inadequate CVR. Our hypothesis is that GBT440 will result in higher hemoglobin levels, reduced hemolysis and decreased sickling resulting in lower viscosity, reduced CBF and increased CVR. The effect on oxygen utilization is uncertain given the contrasting effects on circulating oxygen content versus high oxygen affinity, but will be investigated in parallel.—

Secondary

MeasureTime frame
nvt—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)