SWITCH Trial: The treatment of patients with spontaneous bleeding in the brain

SWITCH Trial: The treatment of patients with spontaneous bleeding in the brain

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

 

Participant countries:  

Switzerland, Austria, Germany, Helsinki, Spain, the Netherlands, France

 

Upcoming participant countries:  

UK

 

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.

The latest issue of ORUEN – CNS Journal now available online

The latest issue of ORUEN – CNS Journal now available online

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

ELAN Study: Should anticoagulants be initiated early or with a certain time delay after a stroke?

ELAN Study: Should anticoagulants be initiated early or with a certain time delay after a stroke?

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.

The Stroke Association UK Helpline Practice Webinar: Pre-Webinar Survey

The Stroke Association UK Helpline Practice Webinar: Pre-Webinar Survey

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.)

Stroke Support Organisation Faculty Tool: Module 3 Launched

Stroke Support Organisation Faculty Tool: Module 3 Launched

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