Effects of Prostacyclin Infusion on Cerebral Vessels and Metabolism in Patients With Subarachnoid Haemorrhage

Effect of Prostacyclin Infusion on Cerebral Vessels, Cerebral Bloodflow and Cerebral Metabolism in Patients With Subarachnoid Haemorrhage

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01447095

Enrollment

Registered

2011-10-05

Start date

2011-10-31

Completion date

2014-06-30

Last updated

2014-07-21

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

Conditions

Subarachnoid Hemorrhage

Keywords

Subarachnoid hemorrhage, vasospasm, prostacyclin

Brief summary

The purpose of this study is to determine whether prostacyclin is effective in prevention of cerebral vasospasm in patients with subarachnoidal hemorrhage (SAH).

Interventions

DRUGProstacyclin 1 ng/kg/min

Continuous i.v. infusion of epoprostenol 1 ng/kg/min day 5-10 after SAH

DRUGProstacyclin 2 ng/kg/min

Continuous i.v. infusion of epoprostenol 2 ng/kg/min day 5-10 after SAH

DRUGPlacebo

Continuous i.v. infusion with placebo day 5-10 after SAH

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* SAH verified by CT * Aneurysm identified and treated * Fisher grade 3 + 4 * WFNS grade 1-4 (World Federation of Neurosurgical Societies )

Exclusion criteria

* Pregnancy/lactation * Heard failure * Kidney failure * Liver failure * Hemorrhagic diathesis

Design outcomes

Primary

Measure	Time frame	Description
Radiographic vasospasm measured by CT perfusion	Day 8 (+/- 1 day) after aneurysm treatment	Changes in regional cerebral blood flow from baseline in the arterial territories of the anterior cerebral artery, medial cerebral artery and the posterior cerebral artery

Secondary

Measure	Time frame	Description
Brain tissue oxygen (PtiO2)	continuous measurement day 3-10 after SAH	Brain tissue oxygen (PtiO2) measured by Licox catheter.
Cerebral metabolism measured by microdialysis	every 2. hour day 3-10 after aneurysm treatment	Cerebral metabolism measured by microdialysis. Lactate, pyruvate, glucose, glutamate and glycerol are measured.
Glasgow outcome scale (GOS) at 3 months	3 months efter SAH	Glasgow outcome scale (GOS) at 3 months obtained by telephone interview.
Mean arterial pressure (MAP)	Continuous day 1-10 after SAH	Mean arterial pressure (MAP) measured by arterial catheter.
Radiographic vasospasm measured by CT angiography	Measured day 8 +/- 1 day	Qualitative assessment (none, mild/moderate, severe) of vasospasm.
Level of brain damage biomarker	daily day 4-11 after SAH	Serum levels of S100b in peripheral blood
Clinical vasospasm	day 5-10 after SAH	Clinical vasospasm defined as delayed neurological deficits (DIND).

Other

Measure	Time frame	Description
Neuropeptide Y	May 2014	Neuropeptide Y will be measured in all patients Day 2-11. The concentration will be related to CBF, angiographic vasospasm and clinical outcome for all patients. The results will be reported in a separate puplication.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026