Subarachnoid HemorrhagePhase 2NCT01447095
Effects of Prostacyclin Infusion on Cerebral Vessels and Metabolism in Patients With Subarachnoid Haemorrhage
A Phase 2 study testing Prostacyclin 1 ng/kg/min and Prostacyclin 2 ng/kg/min in people with Subarachnoid Hemorrhage, run by Rune Rasmussen at 1 site in Denmark.
Trial summary
The purpose of this study is to determine whether prostacyclin is effective in prevention of cerebral vasospasm in patients with subarachnoidal hemorrhage (SAH). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subarachnoid Hemorrhage
- What is being tested?
- Prostacyclin 1 ng/kg/min and Prostacyclin 2 ng/kg/min
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2011to Jun 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- SAH verified by CT
- Aneurysm identified and treated
- Fisher grade 3 + 4
- WFNS grade 1-4 (World Federation of Neurosurgical Societies )
Who cannot join
- Pregnancy/lactation
- Heard failure
- Kidney failure
- Liver failure
- Hemorrhagic diathesis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Prostacyclin Infusion on Cerebral Vessels, Cerebral Bloodflow and Cerebral 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).
- Conditions
- Subarachnoid Hemorrhage
- Being tested
- Prostacyclin 1 ng/kg/min, Prostacyclin 2 ng/kg/min, Placebo
- Keywords
- Subarachnoid hemorrhage, vasospasm, prostacyclin
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostacyclin 1 ng/kg/minDrug
Also called Flolan
Continuous i.v. infusion of epoprostenol 1 ng/kg/min day 5-10 after SAH
Prostacyclin 2 ng/kg/minDrug
Also called Flolan
Continuous i.v. infusion of epoprostenol 2 ng/kg/min day 5-10 after SAH
PlaceboDrug
Continuous i.v. infusion with placebo day 5-10 after SAH
| Study group | Role | What they receive |
|---|---|---|
| Low dose prostacyclin | Active comparator | Not described Receives: Drug: Prostacyclin 1 ng/kg/min |
| High dose prostacyclin | Active comparator | Not described Receives: Drug: Prostacyclin 2 ng/kg/min |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 8 (+/- 1 day) after aneurysm treatment
Secondary outcomes (7)
Cerebral metabolism measured by microdialysis
Cerebral metabolism measured by microdialysis. Lactate, pyruvate, glucose, glutamate and glycerol are measured.
Measured: every 2. hour day 3-10 after aneurysm treatment
Glasgow outcome scale (GOS) at 3 months
Glasgow outcome scale (GOS) at 3 months obtained by telephone interview.
Measured: 3 months efter SAH
Clinical vasospasm
Clinical vasospasm defined as delayed neurological deficits (DIND).
Measured: day 5-10 after SAH
Brain tissue oxygen (PtiO2)
Brain tissue oxygen (PtiO2) measured by Licox catheter.
Measured: continuous measurement day 3-10 after SAH
Mean arterial pressure (MAP)
Mean arterial pressure (MAP) measured by arterial catheter.
Measured: Continuous day 1-10 after SAH
Radiographic vasospasm measured by CT angiography
Qualitative assessment (none, mild/moderate, severe) of vasospasm.
Measured: Measured day 8 +/- 1 day
Level of brain damage biomarker
Serum levels of S100b in peripheral blood
Measured: daily day 4-11 after SAH
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Subarachnoid HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rune Rasmussen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rune Rasmussen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Rune Rasmussen, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01447095
- Sponsor's protocol ID
- 2011-002798-50
- Status last verified
- Jul 2014
- First submitted
- 2 Oct 2011
- Last updated
- 21 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25414173Rasmussen 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.
PubMed 24929796Rasmussen 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.
PubMed 22747768
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prostacyclin Infusion on Cerebral Vessels, Cerebral Bloodflow and Cerebral Metabolism in Patients With Subarachnoid Haemorrhage
- ClinicalTrials.gov ID
- NCT01447095
- Acronym / sponsor ID
- 2011-002798-50
- Conditions
- Subarachnoid Hemorrhage
- Keywords
- Subarachnoid hemorrhage, vasospasm, prostacyclin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Rune RasmussenUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 5 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether prostacyclin is effective in prevention of cerebral vasospasm in patients with subarachnoidal hemorrhage (SAH).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- SAH verified by CT
- Aneurysm identified and treated
- Fisher grade 3 + 4
- WFNS grade 1-4 (World Federation of Neurosurgical Societies )
Key exclusion criteria (5 listed)
- Pregnancy/lactation
- Heard failure
- Kidney failure
- Liver failure
- Hemorrhagic diathesis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prostacyclin 1 ng/kg/minAlso: FlolanContinuous i.v. infusion of epoprostenol 1 ng/kg/min day 5-10 after SAH | Drug | Low dose prostacyclin |
| Prostacyclin 2 ng/kg/minAlso: FlolanContinuous i.v. infusion of epoprostenol 2 ng/kg/min day 5-10 after SAH | Drug | High dose prostacyclin |
| PlaceboContinuous i.v. infusion with placebo day 5-10 after SAH | Drug | Placebo |
Primary outcome
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
7 secondary outcomes
Cerebral metabolism measured by microdialysis
Time frame: every 2. hour day 3-10 after aneurysm treatment
Glasgow outcome scale (GOS) at 3 months
Time frame: 3 months efter SAH
Clinical vasospasm
Time frame: day 5-10 after SAH
Brain tissue oxygen (PtiO2)
Time frame: continuous measurement day 3-10 after SAH
Mean arterial pressure (MAP)
Time frame: Continuous day 1-10 after SAH
Radiographic vasospasm measured by CT angiography
Time frame: Measured day 8 +/- 1 day
Level of brain damage biomarker
Time frame: daily day 4-11 after SAH
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2014.
- Derived from this study: PubMed 25414173Rasmussen 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.
- Derived from this study: PubMed 24929796Rasmussen 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.
- Derived from this study: PubMed 22747768Rasmussen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rune Rasmussen, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prostacyclin 1 ng/kg/min and Prostacyclin 2 ng/kg/min in people with Subarachnoid Hemorrhage, run by Rune Rasmussen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic vasospasm measured by CT perfusion (time frame: Day 8 (+/- 1 day) after aneurysm treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01447095, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2014.