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

Subarachnoid Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01447095
• Other study ID #: 2011-002798-50
• Status: Completed
• Phase: Phase 2
• First received: October 2, 2011
• Last updated: July 18, 2014
• Start date: October 2011
• Est. completion date: June 2014

Study information

• Verified date: July 2014
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hemorrhage
• Subarachnoid Hemorrhage

Intervention

Drug:
• Prostacyclin 1 ng/kg/min
Continuous i.v. infusion of epoprostenol 1 ng/kg/min day 5-10 after SAH
• Prostacyclin 2 ng/kg/min
Continuous i.v. infusion of epoprostenol 2 ng/kg/min day 5-10 after SAH
• Placebo
Continuous i.v. infusion with placebo day 5-10 after SAH

Locations

Country	Name	City	State
Denmark	Rigshospitalet, dep. of neurosurgery	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rune Rasmussen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Neuropeptide Y	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.	May 2014	No
Primary	Radiographic vasospasm measured by CT perfusion	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	Day 8 (+/- 1 day) after aneurysm treatment	No
Secondary	Cerebral metabolism measured by microdialysis	Cerebral metabolism measured by microdialysis. Lactate, pyruvate, glucose, glutamate and glycerol are measured.	every 2. hour day 3-10 after aneurysm treatment	No
Secondary	Glasgow outcome scale (GOS) at 3 months	Glasgow outcome scale (GOS) at 3 months obtained by telephone interview.	3 months efter SAH	No
Secondary	Clinical vasospasm	Clinical vasospasm defined as delayed neurological deficits (DIND).	day 5-10 after SAH	No
Secondary	Brain tissue oxygen (PtiO2)	Brain tissue oxygen (PtiO2) measured by Licox catheter.	continuous measurement day 3-10 after SAH	No
Secondary	Mean arterial pressure (MAP)	Mean arterial pressure (MAP) measured by arterial catheter.	Continuous day 1-10 after SAH	Yes
Secondary	Radiographic vasospasm measured by CT angiography	Qualitative assessment (none, mild/moderate, severe) of vasospasm.	Measured day 8 +/- 1 day	No
Secondary	Level of brain damage biomarker	Serum levels of S100b in peripheral blood	daily day 4-11 after SAH	No