Effect of prostacyclin infusion on cerebral vessels and metabolism in patients with subarachnoid haemorrhage

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-002798-50-DK

Enrollment

Unknown

Registered

2011-08-09

Start date

2011-09-27

Completion date

Unknown

Last updated

2016-09-05

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

Conditions

Vasospasm following subarachnoid hemorrhage MedDRA version: 14.0 Level: LLT Classification code 10042320 Term: Subarachnoid hemorrhage System Organ Class: 10029205 - Nervous system disorders

Interventions

Trade Name: Flolan Pharmaceutical Form: Concentrate and solvent for concentrate for solution for infusion Pharmaceutical form of the placebo: Concentrate and diluent for solution for infusion Route of

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subarachnoid hemorrhage Fisher grade 3 + 4 Aneurysm treated Age > 18 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: Kidney disease Heart failure Hemorrhagic diathesis

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the effect of continues prostacyclin infusion in patient with subarachnoid hemorrhage. Main endpoint is effect on radiographic vasospasm mesured by CT angiography.;Secondary Objective: Secondary endpoints is brain metabolism measured by brain microdialysis, clinical vasospasm and biochemical markers.;Primary end point(s): Intra-arterial diameter i main cerebral arteries measured by CT angiography;Timepoint(s) of evaluation of this end point: By the end of trial, autumn 2012	—

Measure

Time frame

Main Objective: To evaluate the effect of continues prostacyclin infusion in patient with subarachnoid hemorrhage. Main endpoint is effect on radiographic vasospasm mesured by CT angiography.;Secondary Objective: Secondary endpoints is brain metabolism measured by brain microdialysis, clinical vasospasm and biochemical markers.;Primary end point(s): Intra-arterial diameter i main cerebral arteries measured by CT angiography;Timepoint(s) of evaluation of this end point: By the end of trial, autumn 2012

—

Secondary

Measure	Time frame
Secondary end point(s): Brain metabolism measured by brain microdialysis Clinical vasospasm Biochemical markes (markers of endothelial damage) Mortality and morbidity ;Timepoint(s) of evaluation of this end point: By the end of trial, autumn 2012	—

Countries

Denmark

Contacts

Public ContactRune Rasmussen

Rune Rasmussen

rune333@gmail.com4520157524

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026