NCT01447095

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 2, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 5, 2011

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

July 21, 2014

Status Verified

July 1, 2014

Enrollment Period

2.7 years

First QC Date

October 2, 2011

Last Update Submit

July 18, 2014

Conditions

Subarachnoid Hemorrhage

Keywords

Subarachnoid hemorrhagevasospasmprostacyclin

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (7)

  • Cerebral metabolism measured by microdialysis

    every 2. hour day 3-10 after aneurysm treatment

  • Glasgow outcome scale (GOS) at 3 months

    3 months efter SAH

  • Clinical vasospasm

    day 5-10 after SAH

  • Brain tissue oxygen (PtiO2)

    continuous measurement day 3-10 after SAH

  • Mean arterial pressure (MAP)

    Continuous day 1-10 after SAH

  • +2 more secondary outcomes

Other Outcomes (1)

  • Neuropeptide Y

    May 2014

Study Arms (3)

Low dose prostacyclin

ACTIVE COMPARATOR
Drug: Prostacyclin 1 ng/kg/min

High dose prostacyclin

ACTIVE COMPARATOR
Drug: Prostacyclin 2 ng/kg/min

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Prostacyclin 1 ng/kg/minDRUG

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

Also known as: Flolan
Low dose prostacyclin
Prostacyclin 2 ng/kg/minDRUG

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

Also known as: Flolan
High dose prostacyclin
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • SAH verified by CT
  • Aneurysm identified and treated
  • Fisher grade 3 + 4
  • WFNS grade 1-4 (World Federation of Neurosurgical Societies )

You may not qualify if:

  • Pregnancy/lactation
  • Heard failure
  • Kidney failure
  • Liver failure
  • Hemorrhagic diathesis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet, dep. of neurosurgery

Copenhagen, 2200, Denmark

Location

Related Publications (3)

  • Rasmussen R, Wetterslev J, Stavngaard T, Juhler M, Skjoth-Rasmussen J, Grande PO, Olsen NV. Effects of prostacyclin on cerebral blood flow and vasospasm after subarachnoid hemorrhage: randomized, pilot trial. Stroke. 2015 Jan;46(1):37-41. doi: 10.1161/STROKEAHA.114.007470. Epub 2014 Nov 20.

    PMID: 25414173DERIVED

  • Rasmussen R, Juhler M, Wetterslev J. Effects of continuous prostacyclin infusion on regional blood flow and cerebral vasospasm following subarachnoid haemorrhage: statistical analysis plan for a randomized controlled trial. Trials. 2014 Jun 14;15:228. doi: 10.1186/1745-6215-15-228.

    PMID: 24929796DERIVED

  • Rasmussen R, Wetterslev J, Stavngaard T, Skjoth-Rasmussen J, Grande PO, Olsen NV, Romner B. The effects of continuous prostacyclin infusion on regional blood flow and cerebral vasospasm following subarachnoid haemorrhage: study protocol for a randomised controlled trial. Trials. 2012 Jul 2;13:102. doi: 10.1186/1745-6215-13-102.

    PMID: 22747768DERIVED

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Interventions

Epoprostenol

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins IProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Rune Rasmussen, MD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, Sponsor-Investigator

Study Record Dates

First Submitted

October 2, 2011

First Posted

October 5, 2011

Study Start

October 1, 2011

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

July 21, 2014

Record last verified: 2014-07

Locations

DK(1)