Cerebral Vasospasm After Subarachnoid HemorrhageIMCVSNCT01400360
Invasive Diagnostic and Therapeutic Management of Cerebral Vasospasm After Aneurysmatic Subarachnoid Hemorrhage
A study testing Combination of TBA and intraarterial application of vasodilators in people with Cerebral Vasospasm After Subarachnoid Hemorrhage, run by Johann Wolfgang Goethe University Hospital at 5 sites in Germany.
Trial summary
Cerebral vasospasm(CVS) after subarachnoid hemorrhage (SAH) results in a considerable amount of transient or even permanent neurological deficits and poor outcome of the patients. Transluminal Balloon angioplasty (TBA) or intraarterial application of vasodilators represents a rescue therapy for severe CVS. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cerebral Vasospasm After Subarachnoid Hemorrhage
- What is being tested?
- Combination of TBA and intraarterial application of vasodilators
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 5 sitesGermany
- Study dates
- Aug 2009to Aug 2011
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- SAH (WFNS 1-4)
- Perfusion relevant CVS
- Ability for MRI, DSA and intraarterial treatment
Who cannot join
- extended cerebral infarcts
- SAH or ICH from AVM or flow associated aneurysm
- Non aneurismal SAH
- Relevant non spastic stenosis of brain supplying arteries
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites, 3 recruiting
- Active, not recruiting
Neurochirurgische Klinik, Universitätsklinik
Düsseldorf, 40225
- Recruiting
Department of Neurosurgery, Johann Wolfgang Goethe-University
Frankfurt am Main, 60528
Hartmut Vatter, M. D., 069/ 6301 ext. 5939, h.vatter@em.uni-frankfurt.de
Joachim Berkefeld, M. D., 069/ 6301 ext. 5462, j.berkefeld@em.uni-frankfurt.de
- Recruiting
Neurochirurgische Klinik der Universität Ulm
Günzburg, 89312
Ralph König, M. D., 08221 ext. 9600, ralph.koenig@uni-ulm.de
Ralph König, M. D.
- Recruiting
Klinik für Neurochirurgie, Universitätsklinikum
Jena, 07743
Rolf Kalff, M. D., 093641 ext. 9323001, rolf.kalff@med.uni-jena.de
Steffi Neumann, 03641 ext. 9324765, steffi.neumann@med.uni-jena.de
- Active, not recruiting
Klinik für Neurochirurgie, Universitätsklinikum
Mannheim, 68169
About this study
Cerebral vasospasm(CVS) after subarachnoid hemorrhage (SAH) results in a considerable amount of transient or even permanent neurological deficits and poor outcome of the patients. Transluminal Balloon angioplasty (TBA) or intraarterial application of vasodilators represents a rescue therapy for severe CVS. Indication, duration and efficacy of this treatment, however, is still under debate. Aim of the study is to investigate if such a rescue treatment can significantly reduce new delayed ischemic cerebral deficits after SAH. Hypothesis is that the occurance of delayed infarcts can be reduced by repetetive intraarterial therapy to more than 50 %.
- Being tested
- Combination of TBA and intraarterial application of vasodilators
- Keywords
- cerebral vasospasm, subarachnoid hemorrhage, transluminal balloon angioplasty, intraarterial treatment
- Medical subject headings
- Vasospasm, Intracranial, Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination of TBA and intraarterial application of vasodilatorsOther
In the invasive arm CVS should be treated by intraarterial therapy and efficacy controlled by CT or MRI after 48 hours and if necessary repeated.
| Study group | Role | What they receive |
|---|---|---|
| invasive | Active comparator | After proof of perfusion relevant CVS in interventional therapy should be performed as best possible combination from TBA and intraarterial vasodilators additional to the conventional treatment. Receives: Other: Combination of TBA and intraarterial application of vasodilators |
| conventional | No intervention | After proof of perfusion relevant CVS only conventional treatment should be performed (no intraarterial therapy). Receives: Other: Combination of TBA and intraarterial application of vasodilators |
What is being measured
The primary outcome is the main question the study is designed to answer.
New infarcts between baseline and final MRI
Measured: 21 + - 7 days
Secondary outcomes (1)
Clinical outcome (mRS, Karnofsky)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2011 (estimated)
- Study startAug 2009
- Primary completionAug 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Vasospasm After 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01400360
- Sponsor's protocol ID
- JohannWGUH_IMCVS
- Acronym
- IMCVS
- Status last verified
- May 2011
- First submitted
- 21 Jul 2011
- Last updated
- 22 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Invasive Diagnostic and Therapeutic Management of Cerebral Vasospasm After Aneurysmatic Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT01400360
- Acronym / sponsor ID
- IMCVS / JohannWGUH_IMCVS
- Keywords
- cerebral vasospasm, subarachnoid hemorrhage, transluminal balloon angioplasty, intraarterial treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Aug 2011 (estimated)
- First posted
- 22 Jul 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.
Cerebral vasospasm(CVS) after subarachnoid hemorrhage (SAH) results in a considerable amount of transient or even permanent neurological deficits and poor outcome of the patients. Transluminal Balloon angioplasty (TBA) or intraarterial application of vasodilators represents a rescue therapy for severe CVS. Indication, duration and efficacy of this treatment, however, is still under debate. Aim of the study is to investigate if such a rescue treatment can significantly reduce new delayed ischemic cerebral deficits after SAH. Hypothesis is that the occurance of delayed infarcts can be reduced by repetetive intraarterial therapy to more than 50 %.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| invasive | Active comparator | Other: Combination of TBA and intraarterial application of vasodilatorsAfter proof of perfusion relevant CVS in interventional therapy should be performed as best possible combination from TBA and intraarterial vasodilators additional to the conventional treatment. |
| conventional | No intervention | Other: Combination of TBA and intraarterial application of vasodilatorsAfter proof of perfusion relevant CVS only conventional treatment should be performed (no intraarterial therapy). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- SAH (WFNS 1-4)
- Perfusion relevant CVS
- Ability for MRI, DSA and intraarterial treatment
Key exclusion criteria (4 listed)
- extended cerebral infarcts
- SAH or ICH from AVM or flow associated aneurysm
- Non aneurismal SAH
- Relevant non spastic stenosis of brain supplying arteries
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 |
|---|---|---|
| Combination of TBA and intraarterial application of vasodilatorsIn the invasive arm CVS should be treated by intraarterial therapy and efficacy controlled by CT or MRI after 48 hours and if necessary repeated. | Other | conventional, invasive |
Primary outcome
New infarcts between baseline and final MRI
Time frame: 21 + - 7 days
1 secondary outcome
Clinical outcome (mRS, Karnofsky)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2011.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combination of TBA and intraarterial application of vasodilators in people with Cerebral Vasospasm After Subarachnoid Hemorrhage, run by Johann Wolfgang Goethe University Hospital at 5 sites in Germany.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 22 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hartmut Vatter, M. D. (069 / 6301 ext. 5939, h.vatter@em.uni-frankfurt.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New infarcts between baseline and final MRI (time frame: 21 + - 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jul 2011.