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Completed

NCT Number: NCT01447095

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

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

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Key information

Conditions

Subarachnoid Hemorrhage Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Rigshospitalet, dep. of neurosurgery

Copenhagen, 2200, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prostacyclin 1 ng/kg/min

Drug

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

Other names: Flolan

Prostacyclin 2 ng/kg/min

Drug

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

Other names: Flolan

Placebo

Drug

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

Primary outcomes

  1. Radiographic vasospasm measured by CT perfusion

    Time frame: 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 outcomes

  1. Cerebral metabolism measured by microdialysis

    Time frame: every 2. hour day 3-10 after aneurysm treatment

    Cerebral metabolism measured by microdialysis. Lactate, pyruvate, glucose, glutamate and glycerol are measured.

  2. Glasgow outcome scale (GOS) at 3 months

    Time frame: 3 months efter SAH

    Glasgow outcome scale (GOS) at 3 months obtained by telephone interview.

  3. Clinical vasospasm

    Time frame: day 5-10 after SAH

    Clinical vasospasm defined as delayed neurological deficits (DIND).

  4. Brain tissue oxygen (PtiO2)

    Time frame: continuous measurement day 3-10 after SAH

    Brain tissue oxygen (PtiO2) measured by Licox catheter.

  5. Mean arterial pressure (MAP)

    Time frame: Continuous day 1-10 after SAH

    Mean arterial pressure (MAP) measured by arterial catheter.

  6. Radiographic vasospasm measured by CT angiography

    Time frame: Measured day 8 +/- 1 day

    Qualitative assessment (none, mild/moderate, severe) of vasospasm.

  7. Level of brain damage biomarker

    Time frame: daily day 4-11 after SAH

    Serum levels of S100b in peripheral blood

Other outcomes

  1. Neuropeptide Y

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Rune Rasmussen

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Oct 5, 2011
Registry last updated
Jul 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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