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

Phase 2

Completed

• Conditions: Subarachnoid Hemorrhage
• Interventions: Drug: Prostacyclin 2 ng/kg/min; Drug: Prostacyclin 1 ng/kg/min; Drug: Placebo

• Registration Number: NCT01447095
• Lead Sponsor: Rune Rasmussen

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-02
• Study First Submitted QC: 2011-10-02
• Study First Posted: 2011-10-05
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-18
• Last Update Posted: 2014-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High dose prostacyclin	Prostacyclin 2 ng/kg/min	-
Low dose prostacyclin	Prostacyclin 1 ng/kg/min	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Clinical vasospasm	day 5-10 after SAH	Clinical vasospasm defined as delayed neurological deficits (DIND).
Glasgow outcome scale (GOS) at 3 months	3 months efter SAH	Glasgow outcome scale (GOS) at 3 months obtained by telephone interview.
Radiographic vasospasm measured by CT angiography	Measured day 8 +/- 1 day	Qualitative assessment (none, mild/moderate, severe) of vasospasm.
Brain tissue oxygen (PtiO2)	continuous measurement day 3-10 after SAH	Brain tissue oxygen (PtiO2) measured by Licox catheter.
Mean arterial pressure (MAP)	Continuous day 1-10 after SAH	Mean arterial pressure (MAP) measured by arterial catheter.
Level of brain damage biomarker	daily day 4-11 after SAH	Serum levels of S100b in peripheral blood

Trial Locations

Locations (1)

Rigshospitalet, dep. of neurosurgery; 🇩🇰 Copenhagen, Denmark