Endovascular treatment of cerebral vasospasm with milrinone and nimodipine
| ISRCTN | ISRCTN36126862 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36126862 |
| Secondary identifying numbers | 4.1 |
- Submission date
- 31/10/2018
- Registration date
- 21/11/2018
- Last edited
- 16/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
More than 800 people every year in Austria suffer from severe brain bleeding because of ruptured aneurysms. An aneurysm is a balloon-shaped bulging of an arterial vessel within the head. Up to 4% of the population carry an aneurysm, but not all of them rupture. After bleeding from a ruptured aneurysm, severe and potentially lethal complications may follow. One of this is the spastic narrowing of the brain vessels, which is where the blood vessels in the brain can suddenly constrict, leading to reduced blood supply of the brain. This is called a cerebral vasospasm. It leads to a high number of deaths and in survivors, leads to an intensive need for help in daily activities. Currently, there is no specific treatment for cerebral vasospasm. This study aims to look at the effectiveness of a new drug combination (milrinone and nimodipine) for cerebral vasospasm.
Who can participate?
Adults who have had cerebral vasospasm after an ruptured aneurysm and are being treated in Krankenanstalt Rudolfstiftung in Vienna, Austria
What does the study involve?
Participants will be given 2 mg nimodipine for 20 minutes, followed by 5 mg milrinone given over 30 minutes. Participants will stay in intensive care for at least 21 days and will be followed up within at least 6 weeks after discharge.
What are the possible benefits and risks of participating?
There are no known benefits or risks to participants taking part in this study. The only known side effect of the drugs used is low blood pressure; however, this side effect is not seen in the application of drugs used in this study.
Where is the study run from?
Krankenanstalt Rudolfstiftung, Vienna (Austria)
When is the study starting and how long is it expected to run for?
June 2012 to June 2017
Who is funding the study?
Krankenanstalt Rudolfstiftung (Austria)
Who is the main contact?
Dr. Bernhard Wambacher
bernhard.wambacher@wienkav.at
Contact information
Scientific
Juchgasse 25/NChir.
Vienna
1030
Austria
Study information
| Study design | Interventional prospective single center non-randomised study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Repeated combined endovascular therapy with milrinone and nimodipine for the treatment of severe cerebral vasospasm |
| Study objectives | Repeated combined endovascular therapy with milrinone and nimodipine for the treatment of severe vasospasm improves neurological outcome and reduces mortality |
| Ethics approval(s) | Local Ethics Committee of the City of Vienna (Ethikkommission der Stadt Wien), 12/02/2018, EK 16-227-VK-NIS |
| Health condition(s) or problem(s) studied | Severe cerebral vasospasm |
| Intervention | All patients received endovascular therapy with 2 mg nimodipine infused over 20 minutes, followed by 5 mg milrinone infused over 30 minutes into the symptomatic vessels using an angiography catheter positioned extracranially/intra-arterially. All patients were monitored in the intensive care department or an intermediate care set-up for the period they were in a critical condition, but at least up to day 21 after initial bleeding. A routine clinical follow-up was completed within 6 weeks after discharge. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Nimodipine Milrinone |
| Primary outcome measure | Clinical outcome, assessed at the baseline, on the day of discharge and at least 6 weeks after, using the following: 1. Glasgow Outcome Score (GOS) 2. Modified Ranking Scale (mRS) |
| Secondary outcome measures | The following are assessed at the baseline, on the day of discharge and after 6 weeks: 1. Vessel diameter, assessed using the Centricity Universal Viewer through digital subtraction of the angiogram pre- and post-intervention 2. Transcranial Doppler (TCD) values, assessed using a standard transcranial Doppler sonography set |
| Overall study start date | 01/06/2012 |
| Completion date | 30/06/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 85 Years |
| Sex | Both |
| Target number of participants | 38 |
| Total final enrolment | 38 |
| Key inclusion criteria | 1. Aneurysmal subarachnoid haemorrhage 2. Consecutive cerebral vasospasm 3. Treated in Krankenanstalt Rudolfstiftung during the observational period 4. Aged 18-85 years |
| Key exclusion criteria | Not meeting the participant inclusion criteria |
| Date of first enrolment | 01/01/2013 |
| Date of final enrolment | 01/04/2016 |
Locations
Countries of recruitment
- Austria
Study participating centre
Vienna
1030
Austria
Sponsor information
Research organisation
Juchgasse 25/Abteilung Neurochirurgie
Vienna
1030
Austria
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/12/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Publication in the Journal of Critical Care as soon as possible |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available from 01/12/2019. Requests via email from Bernhard Wambacher (bernhard.wambacher@wienkav.at). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/05/2025 | 16/06/2025 | Yes | No |
Editorial Notes
16/06/2025: Publication reference and total final enrolment added.
23/11/2018: Internal review.
