Aug 8, 2018
Solitaire™ With the Intention For Thrombectomy Plus Intravenous t-PA Versus DIRECT Solitaire™ Stent-retriever Thrombectomy in Acute Anterior Circulation Stroke (SWIFT DIRECT)
Background
The SWIFT DIRECT trial investigates the emergency treatment of patients with an acute ischaemic stroke. An ischaemic stroke is caused by the blockage of one or more blood vessels in the brain. A clot blocks the blood vessels and blood can no longer circulate. This results in an undersupply of blood and oxygen to the brain regions supplied by these vessels. If the under-supply lasts longer than a few minutes, there is a risk that nerve cells might die. An ischaemic cerebral infarction is a life-threatening situation.
For years, the only causal treatment was the administration of a clot-lysing drug called tissue plasminogen activator. The drug, however, may induce bleedings and is not sufficiently effective in patients with very large clots. In 2014, a new treatment, the so-called mechanical thrombectomy, has been established. With this therapy, nearly all types of large blood clots can directly be removed from the vessel using a specialized catheter. Trials have shown that patients treated with tissue plasminogen activator and mechanical thrombectomy have better outcomes than patients treated with tissue plasminogen activator only. Hence, the current standard treatment in patients with large clots is administration of tissue plasminogen activator followed by mechanical thrombectomy.
As administration of tissue plasminogen activator may also harm the patient and is not effective in patients with large clots, we want to investigate how potent direct mechanical thrombectomy (without prior administration of tissue plasminogen activator) is. The purpose of this trial is thus to compare direct removal of the clot with mechanical thrombectomy versus tissue plasminogen activator administration followed by removal of the clot with mechanical thrombectomy. Only patients with large clots and direct access to mechanical thrombectomy can be included in the trial.
We are conducting this trial to improve the emergency treatment for affected patients with an acute ischaemic stroke. This project is organised by the Neuro Clinical Trial Unit at the University of Bern, Switzerland and will be carried out at several hospitals in Europe and Canada.
What does it mean for patients to participate in this clinical trial?
Trial participants will be assigned by chance to one of two groups (half of the patients will be in each group). In the ‘treatment group’ the blood clot is removed directly with mechanical thrombectomy. In the ‘standard group’, participants first receive blood clot-dissolving medication followed by mechanical thrombectomy to remove the clot.
Both treatment options are commonly used standard treatments. The choice between the two is part of clinical routine at the hospital and lies upon the judgement of the treating physician. Except for the phone interview 90 days after the infarction incident, all examinations are part of standard treatment routine independent from the trial.
General information about the trial
| Study type: |
Multicenter, prospective, randomized, open label, blinded endpoint (PROBE) trial |
| Trial start and end: |
October 2017 to December 2020 |
| Sponsor-Investigators: |
Prof. Dr. med. Urs Fischer, Neurology, and
Prof. Dr. med. Jan Gralla, Neuroradiology,
University Hospital Bern, Inselspital, Switzerland |
| Total number of participants: |
404 patients |
| Trial duration for each participant: |
3 months |
| Participating countries: |
Austria, Canada, Finland, France, Germany, Spain and Switzerland |
| Financial support: |
Medtronic (Minneapolis, USA) |
| Trial registration: |
www.clinicaltrials.gov, No.: NCT03192332 |
Please visit the website www.swift-direct.com for further information.
This trial is endorsed by SAFE.
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
|
| 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.
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.)
