Aug 8, 2018
Swiss trial of decompressive craniectomy versus best medical treatment of spontaneous supratentorial intracerebral hemorrhage (SWITCH): a randomized controlled trial
Background
The SWITCH trial investigates the treatment of patients with spontaneous intracerebral hemorrhage (bleeding in the brain). Bleeding in the brain leads to severe brain dysfunctions due to the hemorrhage itself, but also from the brain swelling (brain edema). Each year, about 2 million people worldwide are affected by this disease. The majority of surviving patients remains handicapped. Apart from the standard best medical treatment, there is no possibility to help these patients until now.
Decompressive craniectomy (removal of parts of the cranial bone) is a standard surgical treatment, which is beneficial in patients with brain swelling after a severe ischemic stroke (under- supply of blood and oxygen in certain brain regions due to occlusion of a blood vessel by a blood clot), after brain injuries, but also in patients with meningitis. However, no trial has so far investigated the effectiveness of decompressive craniectomy in patients with brain bleeding. With this trial we would like to investigate in patients with a brain bleeding, whether this treatment method can reduce mortality and dependency compared to best medical treatment. In a larger context, this trial aims to offer a future treatment option to patients with brain bleeding, which can reduce both mortality and disability.
This project is organized by the Neuro Clinical Trial Unit at the University of Bern, Switzerland, and is carried out throughout Europe.
What does it mean for patients to participate in this clinical trial?
All patients will be will be assigned by chance to two groups (half of patients will be in each group). In the ‘treatment group’, surgery (decompressive craniectomy) plus best medical treatment will be performed. The patient’s own cranial bone will be re-inserted (re-implanted) after reduction of the swelling in the brain. This usually takes place after about 3 months. In the ‘standard group’, the participants receive best medical treatment, which is the current standard treatment.
A telephone interview will be performed with all patients 30 days, 6 and 12 months after randomization. Apart from the telephone interviews, all examinations are carried out regardless whether or not the patient participates in this trial.
General information about the trial
| Study type: |
Multicenter randomized (1:1) controlled parallel group trial
|
| Trial start and end: |
October 2014 to September 2020
|
| Sponsor-Investigator: |
Prof. Dr. med. Urs Fischer, Inselspital Bern, Switzerland
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| Participant countries: |
Switzerland, Austria, Germany, Helsinki, Spain, the Netherlands, France
|
| Upcoming participant countries: |
UK
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| Total Number of participants: |
300 patients |
| Trial duration for each participant: |
12 months |
| Financial support: |
Swiss National Science Foundation (SNCF), Swiss Heart Foundation, Inselspital Foundation |
| Trial registration: |
www.clinicaltrials.gov, No.: NCT02258919 |
For further information, please visit the SWITCH Website
This project is endorsed by SAFE.
Aug 6, 2018
Oruen – The CNS Journal is a peer-reviewed, open access publication, and has received CME accreditation from the European Accreditation Committee in CNS (EACIC), with a 100% focus on original CNS research topics, and the latest advances, diagnoses, and treatment of CNS disorders.
The Journal is distributed in print and electronically to thousands of physicians, researchers, academics, nurses, and related healthcare professionals with an interest in CNS disorders. Both subscription and access are free and there are no contributory author fees for publication. Papers submitted for publication are accepted based on their originality, likely impact on and relevance to clinical practice, data quality, and overall potential interest to the journal’s readership.
Oruen – The CNS Journal is published bi-annually. The first issue of the journal was published in May 2015
You can access the latest issue by clicking on the photo below:
For any questions or submission requests/enquiries please contact Dr James Coe – Head Editor editor@oruen.com
Aug 6, 2018
Early versus Late initiation of direct oral Anticoagulants in post-ischaemic stroke patients with atrial fibrillatioN (ELAN) started with the recruitment in October 2017 with currently approximately 80 sites in Switzerland and European countries.
This pragmatic investigator-initiated international trial will add evidence to the best time of starting DOAC after ischaemic stroke in patients with atrial fibrillation. If earlier initiation of DOACs in patients with ischaemic stroke related to atrial fibrillation is shown to be safe and efficacious, this could have a major impact on better treatment adherence, length of hospital stay and patient outcome.
We used an opportunity to talk with Urs Fischer, Professor for Acute Neurology and Stroke (Extraordinarius) at the University Hospital (Inselspital), Bern and principal investigator of the ELAN trial (www.elan-trial.ch).
1. What is ‘atrial fibrillation’ or ‘AF’ and why is it important to know more about it?
Atrial fibrillation is a condition of the heart that is characterized by an abnormal heart rhythm. If you suffer from AF, the atria, two of the chambers in the heart, beat very rapid and irregular. Atrial fibrillation can be episodic or chronic and symptomatic or asymptomatic. It is a very relevant condition because people with atrial fibrillation have a higher risk of suffering from a stroke or a heart failure. Atrial fibrillation is very widespread around the world, especially in the elderly population and causes major mortality and morbidity.
2. What is your personal involvement with the subject of AF, how long are you interested in this subject?
I am currently working as a Professor for Acute Neurology and Stroke at the University Hospital Bern, Switzerland and I am very passionate to find new approaches to prevent and treat strokes. Stroke has a major impact on the quality of life of my patients and their relatives and one of the main causes of a stroke is AF. Therefore, AF needs to be detected and treated.
3. Is there a way to discover AF in time to prevent stroke?
Yes, AF can be detected by cardiac monitoring. Some patients complain about shortness of breath or an irregular pulse. However, it is not uncommon that atrial fibrillation is only diagnosed after the patient has suffered a stroke, especially when AF is asymptomatic and only occurring in episodes and not all the time. Missing these patients is a problem and improving the diagnosis in such patients is a challenge that occupies physicians around the world.
4. Is AF treatable and how?
Atrial fibrillation can be treated or rather managed in a number of ways. The most important approach in the management of AF is to prevent the formation of clots in the heart, which then can cause a stroke or an embolism in other parts of the body. If a patient with AF is at risk of suffering a stroke, anticoagulants (i.e. blood thinners) should be started by the treating physician. If atrial fibrillation is symptomatic by i.e. shortness of breath, cardiologists try to restore a normal heart rhythm. This can be achieved either with drugs or with (minimal invasive) surgery. If the patient is asymptomatic, anticoagulation and frequency control in case of tachycardia are the main goals of therapy.
5. In your opinion, why is the initiation of direct oral Anticoagulants in post-ischaemic stroke patients with atrial fibrillation important?
Post-ischaemic stroke patients are at a high risk of suffering a second stroke soon after the first event. This is called a recurrent stroke. Treatment with oral anticoagulants reduces the risk of a recurrent stroke significantly. Direct oral anticoagulants are the newest class of anticoagulants and compared to older ones, they are just as effective but safer. However, the time point when these drugs should be started after a stroke is unknown. Therefore, we have designed the ELAN trial (Early versus Late initiation of direct oral Anticoagulants in post-ischaemic stroke patients with atrial fibrillatioN (ELAN): an international, multicentre, randomised-controlled, two-arm, assessor-blinded trial; www.elan-trial.ch), in which we currently assess, whether anticoagulants should be started early or with a certain time delay after a stroke.
6. When did the research project ELAN started and what do you expect would change once the research is completed?
The first hospitals started recruiting patients in October 2017. After completion, the results of this trial will help us to understand more about the safety and the potential benefits of an early treatment start with direct oral anticoagulants compared to a later treatment start. The results will give physicians a scientific justification of when to start treatment. ELAN could possibly change the way how post-ischaemic stroke patients with atrial fibrillation are treated.
7. Who is funding this research and do you involve patients/ stroke support organisations in it?
ELAN is funded by the Swiss National Science Foundation and the Swiss heart Foundation. Furthermore, it is endorsed by SAFE, the Stroke Alliance for Europe.
About Prof. Urs Fischer
Urs Fischer is Professor for Acute Neurology and Stroke (Extraordinarius) at the University Hospital (Inselspital), Bern. He is chair of the Neurological Inpatient Department, co-chair of the Stroke Center Bern, and deputy director of the Clinical Trial Unit (CTU) of the University of Bern. He is a clinical researcher and his main research interest involves diagnosis, treatment and outcome of patients with acute neurological diseases. He is co-principal investigator of the SWITCH study (www.switch-trial.ch), principal investigator of the ELAN trial (www.elan-trial.ch) and co-principal investigator of the SWIFT DIRECT trial (www.swift-direct.ch). Urs Fischer is Secretary General of the European Stroke Organisation (ESO), treasurer of the Swiss Neurological Society (SNG) and co-founder the ESO ESMINT ESNR Stroke Winter School, which is regularly held at the University Hospital in Bern, Switzerland.
Aug 2, 2018
The role of a helpline is to provide information and support in a trusted space through non face-to-face channels. A helpline can provide support throughout the country or in a local area. Helpline practice is needed to create a service remit and boundaries which sets out a clear definition of what the helpline does and doesn’t do. Good helpline practice can involve developing a set of guidelines around how the helpline works on a daily basis.
The Stroke Association Helpline provides information, guidance and support to anyone affected by stroke over the telephone, by e-mail, letter and through social media. On the helpline, we provide enquirers with information about all topics relating to stroke, from what a stroke is to what should happen after a stroke, from stroke prevention to stroke recovery. We will listen, provide reassurance, offer encouragement, make suggestions and signpost to stroke clubs and a range of local and national services and organisations for further support or specific assistance or advice.
Staff working on the Stroke Association Helpline receive weekly debrief sessions which provides a space away from the helpline to talk through any enquiries that may be challenging or emotional. Within the Stroke Association, staff can also access an employee assistance programme which is a confidential support telephone service.
To help us make this hour long webinar on helpline practice is as useful and interesting to you as possible, we would like to hear from you about what you would like us to focus on. Do not worry if you cannot attend the webinar, we will record it and share it with you. Please download the survey questionnaire here and return it to Sarah Belson sarah.belson@stroke.org.uk by 10th September.
Date for the webinar: 25th September
(The time of the webinar will be confirmed once we know where in the world participants are joining from to ensure the best time possible.)
Jul 30, 2018
Brussels, July 30, 2018- The eLearning Module 3 of the Stroke Support Organisation Faculty Tool (SSOFT) is published today at the following address www.ssoft.info.
SSOFT’s third module focuses on understanding different types of evidence; how to collate it and how Stroke Support Organisations can use it to their advantage:
3.1 – Use of evidence
3.2 – Types of evidence
3.3 – Interpreting evidence & data
3.4 – How SSOs generate data & evidence
3.5 – Using evidence & data in your communications
Stroke Support Organisations have been at the heart of this tool. For newer or smaller organisations, the information in the tool will provide knowledge that will help them to build and grow their communities.
Larger organisations can also benefit from SSOFT, which can enable them to support their communities and other stroke professionals across Europe, adding more voices to their movement/arguments for change.
This tool is also for anyone who is interested in knowing more about what an SSO is, how to start and develop one and how to make it sustainable.
For those interested in using this innovative eLearning platform, we would encourage them to visit the SSOFT website www.ssoft.info
About SSOFT
SSOFT is an innovative online eLearning advocacy tool being developed by Stroke Alliance for Europe (SAFE), in partnership with the European Stroke Organisation (ESO).
This online learning platform provides knowledge and training on how the creation of effective advocacy activities and campaigns to deliver positive change at a local and national level on stroke prevention, treatment and care. The eLearning platform will include six modules that provide information on:
Module 1: Stroke Support Organisations (SSOs)
Module 2: Making Change Happen
Module 3: Use of Evidence
Module 4: Role of Patient Voice
Module 5: Health System Advocacy
Module 6: Public Advocacy
The modules and learning environment is accessible via the SSOFT website through a simple registration process. Visitors to the website can also learn more about SSOFT, SAFE and ESO, find their nearest SAFE Stroke Support Organisation (SSO) as well as hear from SAFE members about their experiences.
For more information, please send an email ssoft@safestroke.eu or visit www.ssoft.info
Acknowledgments
SAFE would like to take this opportunity to thank and acknowledge the contributions made by those who have helped in the development of SSOFT and module 1.
Stroke Alliance for Europe Board, who have been involved at every stage of development of this module.
The Peer Reviewers for module 3:
- Stiftung Deutsche Schlaganfall-Hilfe (Dr Markus Wagner)
- Hellenic Alliance/Action for Stroke Support Organization (Dr Hariklia Proios)
- Macedonian Stroke Association (Dr Anita Arsovska & Dr. Maja Bozinovska Smiceska)
- Norsk forening for slagrammede (Ms Grethe Lunde)
- Thessaloniki and Wiesbaden NRZ, Rehabilitation Center Germany (Dr Dimitris Artemis)
- Aristotle University, Greece (Dr Katerina Nicolaidis)
- Anagenissis Rehabilitation Center, Greece (Ms Eugenia Stamatiou)
Our members who have shared their experiences and knowledge in the video interviews used within the module:
- Chris Macey – The Irish Heart Foundation, R.Ireland
- Pnina Rosenzweig – Neeman Association for Stroke Survivors, Israel
- Ove Puisto – STROKE-Riksförbundet, Sweden
- Markus Wagner – Stiftung Deutsche Schlaganfall-Hilfe, Germany
- Monique Lindhout – Hersenletsel, Netherlands
Our partner organisations who have collaborated in the development of the module content:
- World Stroke Organization
- European Stroke Organisation.
And all those who participated in the User Acceptance Testing of Module 3.
We would also like to thank the project sponsor Bayer Healthcare who have supported this project through an education grant.
About SAFE
The Stroke Alliance for Europe (SAFE) a non-profit-making organisation formed in 2004. It is the voice of stroke patients in Europe, representing a range of patient groups from 30 European countries.
SAFE’s goal is to decrease the number of strokes in Europe by advocating for better prevention, access to adequate treatment, post-stroke care and rehabilitation.
For more information about SAFE, please visit www.safestroke.eu
Jul 27, 2018
The 15 min round table discussion by Christina Sjöstrand, Stockholm, Hans-Christoph Diener, Essen and George Ntaios, Thessaly, focuses on the concepts of randomized clinical trials for secondary stroke prevention in patients with embolic stroke of undetermined source (ESUS). Two large clinical trials tested the hypothesis that non-vitamin K antagonist oral anticoagulants (NOACs) might be superior to aspirin in preventing recurrent strokes after ESUS.
ESUS is a type of ischemic stroke with unknown origin, i.e. for which no probable cause can be identified after standard diagnostic evaluation. Thus, ESUS is a subgroup of cryptogenic stroke, which also includes strokes with incomplete evaluation and those for which more than one probable cause. Non-lacunar strokes in patients without no major-risk cardioembolic source (such as atrial fibrillation), no major atherosclerosis of the arteries supplying the brain infarct area and no other specific cause of their stroke are identified as ESUS.
Current strategy for secondary stroke prevention is based on antiplatelets but stroke recurrent rates remain high. A historical trial, WARSS, pointed at a potential advantage of anticoagulation over antiplatelet in patients with cryptogenic stroke. There is broad evidence for anticoagulation for stroke prevention in atrial fibrillation, thus providing another rationale for testing anticoagulation in ESUS.
Two large trials randomized ESUS patients for long-term treatment with either a NOAC or aspirin: NAVIGATE ESUS was stopped after an interim analysis as efficacy was not different with rivaroxaban compared with aspirin but showed an increased risk of major bleeding. RE-SPECT ESUS is still ongoing as planned; in this trial dabigatran is tested against aspirin. Results will be presented in October 2018. If the trial is positive, i.e. showing greater efficacy of dabigatran in the prevention of stroke recurrence than aspirin, this may not only have great implications of how ESUS patients are treated but could also lead to a simplified post-stroke diagnostic workup for most patients with ischemic stroke.
Please click on the photo below to access the round table video.
Jul 25, 2018
Every year, up to 1.3 million people in Europe suffer a first stroke. Acute stroke treatment strategies such as acute treatment of patients in a stroke unit, intravenous thrombolysis and endovascular treatment significantly improve the outcome for patients with ischaemic stroke and thus reduce its socioeconomic burden. However, reliable data on access to and delivery of acute stroke treatment strategies throughout Europe are lacking.
The European Stroke Organisation (ESO), the European Society of Minimally Invasive Neurological Therapy (ESMINT), the European Academy of Neurology (EAN) and the patient organisation Stroke Alliance for Europe (SAFE) have therefore surveyed stroke experts from 44 of 51 European countries on the best available information regarding national access to and delivery rates of acute stroke unit care, intravenous thrombolysis, and endovascular treatment.
The results of this survey identify major inequalities in acute stroke treatment, with many countries reporting rates that were far below highest country rates. This article shows in which countries patients still have no or obviously inadequate access to appropriate acute stroke treatment.
According to Urs Fischer, Professor for Acute Neurology and Stroke at the University Hospital Bern, up to 226,662 additional patients could be treated with intravenous thrombolysis and an additional 67,347 with endovascular treatment each year. “Many stroke victims in Europe still have no access to acute stroke treatment,” he said. “If stroke unit care, intravenous thrombolysis and endovascular therapy would be routine practice throughout Europe, many more victims could survive their stroke without a major handicap”. According to Prof. Fischer, these inequalities not only have a major impact on the patients, but also on their families and the socioeconomic burden. “Recent studies have shown, that acute stroke treatment is highly cost effective – if you treat your patients right, you will not only improve the quality of life of the patient and his family, you will also save money for your society”, he said. Therefore, efforts have to be done to increase the number of stroke units, intravenous thrombolysis and endovascular stroke therapy. “We have to talk to governments, politicians, health care specialists and stroke physicians in order to set up and improve the system in regions, where acute stroke treatment is lacking!”
In May 2018, ESO and SAFE presented the Stroke Action Plan for Europe to set achievement goals for stroke care by 2030. This survey already provided important insights for the Stroke Action Plan authors. The findings from this survey are relevant for future health-care planning in Europe and beyond.
Contact
Prof. Dr. med Urs Fischer
Department of Neurology, University Hospital Bern
urs.fischer@insel.ch European Stroke Organisation www.eso-stroke.org
Article Title and Citation
Access to and delivery of acute ischaemic stroke treatments: a survey of national scientific societies and stroke experts in 44 European countries
http://journals.sagepub.com/doi/full/10.1177/2396987318786023
Authors
Diana Aguiar de Sousa, Rascha von Martial, Sònia Abilleira, Thomas Gattringer, Adam Kobayashi, Miquel Gallofré, Franz Fazekas, Istvan Szikora, Valery Feigin, Valeria Caso, Urs Fischer, on behalf of the ESO ESMINT EAN SAFE Survey on Stroke Care collaborators
About the Authors
Diana Aguiar de Sousa: First author
Diana Aguiar de Sousa is Neurologist at Hospital de Santa Maria, in Lisbon, and assistant professor of Neuroanatomy at University of Lisbon. She is clinical investigator at Instituto de Medicina Molecular and PhD student at University of Lisbon, under the guidance of Prof. JM Ferro and Prof. P. Canhão. She completed the Clinical Scholars Research Training Certificate Program from Harvard Medical School and a European Academy of Neurology Research Fellowship in acute stroke at Inselspital Bern, Switzerland. Diana Sousa was awarded with the European Stroke Organization (ESO) Young Investigator Award in 2016. She is member of the ESO Young Stroke Physicians and Researchers Committee.
Urs Fischer: Corresponding author
Urs Fischer (urs.fischer@insel.ch)is Professor for Acute Neurology and Stroke (Extraordinarius) at the University Hospital (Inselspital), Bern. He is chair of the Neurological Inpatient Department, co-chair of the Stroke Center Bern, and deputy director of the Clinical Trial Unit (CTU) of the University of Bern. He is a clinical researcher and his main research interest involves diagnosis, treatment and outcome of patients with acute neurological diseases. He is co-principal investigator of the SWITCH study (www.switch-trial.ch), principal investigator of the ELAN trial (www.elan-trial.ch) and co-principal investigator of the SWIFT DIRECT trial (www.swift-direct.ch). Urs Fischer is Secretary General of the European Stroke Organisation (ESO), treasurer of the Swiss Neurological Society (SNG) and co-founder the ESO ESMINT ESNR Stroke Winter School, which is regularly held at the University Hospital in Bern, Switzerland.
Jul 24, 2018
Since this May, in selected hospitals in 12 European countries: Spain, Serbia, Poland, Czech Republic, Latvia, Croatia, Macedonia, Greece, Ukraine, Georgia, Hungary and Turkey, stroke patients and their carers are being provided with information on stroke and important next steps on their path to recovery.
The patient-focused materials are made of five brochures, including a list of national, regional and local stroke support organisations, with their contact details, in order that patients and carers can access further support in the months and years following their stroke. The information provided in the brochures are kindly provided by the Stroke Association UK and then translated to all project languages, applying the information standard procedure for the translation.
The next step in SAFE Angels project consists of collecting feedback from patients and their carers about the quantity and quality of information they have been provided with during their stay at the hospital, before being discharged. The feedback will be collected through an online survey in all 13 project languages (Spanish, Catalan, Serbian, Polish, Czech, Latvian, Croatian, Macedonian, Greek, Ukrainian, Georgian, Hungarian and Turkish).
Please see the survey on this link and inform the people you know.
For more information about the hospitals which are providing patient materials, please find an organisation which is working in your country here.
If you are interested in finding out more about the SAFE Angels project, please contact Jelena Misita, SAFE Awareness and Advocacy Manager at jelena.misita@safestroke.eu.
Jul 23, 2018
Slovenian stroke support organisation »Združenje bolnikov s cerebrovaskularno boleznijo Slovenije« is one of SAFE’s very active members. We recently received an authored text about their stroke awareness activities in May 2018 from Jelka Janša, who is an active member of the Slovenian stroke support organisation and past SAFE President.
…
Written by Jelka Janša
To promote the European Stroke day, there were two main activities namely: the city walk in Ljubljana and two teleconferences. In addition, 400 posters with message about FAST campaign in Slovenian – GROM were displayed around Slovenia for a period of April 24 till May 8. Further to that, 8 professional lectures were sponsored to be delivered within stroke clubs around Slovenia aiming to share again information about the facts about stroke.
Second city walk in Ljubljana was on actual European Stroke Day, May 8. This year the distance was 1,6 km and there were 260 stroke survivors and their supporters attending. It ended at the city Centre, »Prešernov trg«, were there were stands with information about stroke, its prevention including leaflets about Slovenian Stroke Support Organisation and Slovenian Heart Organisation. People, passing by, had the opportunity to have their cholesterol and blood pressure checked. There were four speeches, by Milan Čuček, president of SSSO, Tatjana Erjavec, vice-president of the SSSO, Mr. Zalar from Heart organisation and by Mr Jankovič, the major of Ljubljana. Participants continued with a lunch at the Livada restaurant in Ljubljana.
Two teleconferences were held to emphasize the message about Life after stroke and stroke facts; the first one already on April 23 and organized by Slovenian Heart organisation with representatives from SSSO. They were talking about stroke issues and notified the journalist already about the ESD and the next teleconference, on May 23. The May’s conference was organized by the SSSO and in addition to talking about the life after stroke issues, Tatjana Erjavec also spoke about »Stroke Action Plan in Europe«, the policy paper prepared by both the SAFE and ESO and presented at the same day in EP.
May activities have been well covered by national and local media with 66 publications, including TV, radio and newspapers.The activities were kindly sponsored by University rehabilitation Institute –SOČA, Bayer, Boehringer Ingelheim, Medis, Soča Oprema, Timing Ljubljana, SERVIER Pharma and Mountain Rescue team.
Please look at some of the photos from these activities.
Jul 20, 2018
The World Stroke Congress 2018’s late breaking abstract submission is now open. Don’t miss this last opportunity to be part of this year’s program! Share your work now, and get valuable feedback from colleagues and leaders in the field, opportunities for collaborations and ideas for future research. Review the topics and the guidelines, and submit your abstract today.
The deadline for submission is August 15. Find all the information here.
