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

Rune Rasmussen

Status and phase: Completed; Phase 2

Conditions: Subarachnoid Hemorrhage

Treatments: Drug: Placebo; Drug: Prostacyclin 2 ng/kg/min; Drug: Prostacyclin 1 ng/kg/min

Study type: Interventional

Funder types: Other

Identifiers

NCT01447095

2011-002798-50

Details and patient eligibility

About

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

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 3 patient groups, including a placebo group

Low dose prostacyclin

Active Comparator group

Treatment:

Drug: Prostacyclin 1 ng/kg/min

High dose prostacyclin

Active Comparator group

Treatment:

Drug: Prostacyclin 2 ng/kg/min

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo