Condition category
Circulatory System
Date applied
31/10/2018
Date assigned
21/11/2018
Last edited
23/11/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Bernhard Wambacher

ORCID ID

Contact details

Juchgasse 25/NChir.
Vienna
1030
Austria

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

4.1

Study information

Scientific title

Repeated combined endovascular therapy with milrinone and nimodipine for the treatment of severe cerebral vasospasm

Acronym

Study hypothesis

Repeated combined endovascular therapy with milrinone and nimodipine for the treatment of severe vasospasm improves neurological outcome and reduces mortality

Ethics approval

Local Ethics Committee of the City of Vienna (Ethikkommission der Stadt Wien), 12/02/2018, EK 16-227-VK-NIS

Study design

Interventional prospective single center non-randomised study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

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

Phase

Not Applicable

Drug names

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 trial start date

01/06/2012

Overall trial end date

30/06/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aneurysmal subarachnoid haemorrhage
2. Consecutive cerebral vasospasm
3. Treated in Krankenanstalt Rudolfstiftung during the observational period
4. Aged 18-85 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

38

Participant exclusion criteria

N/A

Recruitment start date

01/01/2013

Recruitment end date

01/04/2016

Locations

Countries of recruitment

Austria

Trial participating centre

Krankenanstalt Rudolfstiftung
Juchgasse 25, 1030
Vienna
1030
Austria

Sponsor information

Organisation

Cerebrovascular Research Group Vienna

Sponsor details

Juchgasse 25/Abteilung Neurochirurgie
Vienna
1030
Austria

Sponsor type

Research organisation

Website

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Publication in the Journal of Critical Care as soon as possible

IPD sharing statement:
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).

Intention to publish date

01/12/2018

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

23/11/2018: Internal review.