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WAKE UP Clinical Trial Update

Nov 27, 2017

WAKE-UP is a European multicentre investigator-initiated randomized placebo-controlled clinical trial of MRI based thrombolysis in acute stroke patients with unknown time of symptom onset, e.g. due to recognition of stroke symptoms on awakening.

Stroke is a devastating disease leading to death and disability in large numbers of patients with massive social and economic impact. Intravenous thrombolysis with Alteplase is available as effective and safe treatment of acute stroke within 4.5 hours of symptom onset. However, in about 20% of acute stroke patients time of symptom onset is unknown e.g. because symptoms are recognized when waking-up from sleep in the morning. This large group of patients is currently excluded from treatment with Alteplase only due to the missing information on the time of symptom onset. In preparatory work the WAKE-UP consortium has developed an innovative approach of using brain MRI as surrogate marker of stroke lesion age which may be used to identify stroke patients likely to benefit from thrombolysis.

The Project started in 2013. As of June 30, enrollment in the WAKE-UP trial was stopped following a decision by the Steering Committee. By the end of enrollment, 1,377 patients were enrolled in WAKE-UP with 501 patients randomized and 876 screen failures. The final meeting was held in Hamburg, Germany, in November 2017.

WAKE UP was led by an active and motivated consortium combining central trial management with decentralised organisation with national coordinators, with a clear communication structure and share of responsibilities, which led to the successful completion of the project.

WAKE-UP is a European collaborative research project launched by a consortium of academic and SME partners destined to improve the treatment of stroke patients. The core of WAKE-UP is an investigator-initiated randomized controlled trial of MRI based thrombolysis in patients waking up with stroke symptoms.

The objective of WAKE-UP is to test efficacy and safety of MRI-based intravenous thrombolysis with Alteplase in patients waking up with stroke symptoms or patients with unknown symptom onset. By this, WAKE-UP aims at providing a new safe and effective treatment option for acute stroke patients waking up with stroke symptoms.

The project is centrally coordinated by the Universitätsklinikum Hamburg-Eppendorf (Prof. Christian Gerloff; deputy coordinator: Dr. Götz Thomalla).

During the WAKE UP trial, imaging software (SONIA) was developed for the purpose of this project, yet this software can also be used even when WAKE UP trial is done, for other research projects in the future.

One of the collateral benefits of this project was that clinicians/ investigators were trained in reading MRI images, providing a learning opportunity for these stroke professionals in the interpretation of MRI in acute stroke diagnostics. Almost 400 investigators from eight European countries participated in a structured software-based training.

WAKE UP trial proved to be a good example on how to involve patients who are unable to give consent.

Repeated interim analysis of safety data from the trial and evaluation by the independent Data and Safety Monitoring Board already showed that the intervention performed in this trial was proven to be safe for patients.

The final results of the main research will be presented to the public in May 2018 at ESOC 2018 conference.

For further information, please visit the Wake-Up project’s web site.

WAKE-UP – The work leading to these results has received funding from the European Union Seventh Framework Programme (FP7/2007-2013) under grant agreement n° 278276.

Please see or download WAKE-UP update in English language or in languages from the following countries:

Iceland
Hungary
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6th ESO Guidelines Development Workshop, 16 November 2017 in Munich, Germany

Nov 27, 2017

by ESO | 24.11.2017
Author: Marialuisa Zedde, MD, Arcispedale Santa Maria Nuova IRCCS, Reggio Emilia, Italy

ESO organized this workshop in Munich on November 16 2017 just before the Garmish conference.

The aim of this workshop was to detail methodological issues in guidelines production, mainly following step by step the GRADE methodology.

Both speakers and talks in the workshop were of high quality level and each talk was complete and interactive. The ability of the speakers was to make simple and easy to listen and learn some complex topics, being open to the discussion and to answer the questions from the audience. (more…)

Hormone therapy in the menopause transition does not increase risk of stroke

Nov 25, 2017

Postmenopausal hormone therapy is not associated with increased risk of stroke, provided that it is started early, according to a report from Karolinska Institutet in Sweden published in the journal PLOS Medicine.

Roughly three in ten women in the menopause transition are afflicted by symptoms that seriously affect their wellbeing, such as hot flushes, dry mucosa and insomnia. However, although the symptoms can be treated effectively with female sex hormones, prescriptions have been low over the past 15 years as researchers have demonstrated a link between such therapy and an increased risk of certain diseases, including stroke. (more…)

Hibernating ground squirrels provide clues to new stroke treatments

Nov 23, 2017

In the fight against brain damage caused by stroke, researchers have turned to an unlikely source of inspiration: hibernating ground squirrels.

While the animals’ brains experience dramatically reduced blood flow during hibernation, just like human patients after a certain type of stroke, the squirrels emerge from their extended naps suffering no ill effects. Now, a team of NIH-funded scientists has identified a potential drug that could grant the same resilience to the brains of ischemic stroke patients by mimicking the cellular changes that protect the brains of those animals. The study was published in The FASEB Journal, the official journal of the Foundation of American Societies for Experimental Biology. (more…)

Virtual reality training may be as effective as regular therapy after stroke

Nov 22, 2017

Using virtual reality therapy to improve arm and hand movement after a stroke is equally as effective as regular therapy, according to a study published in the November 15, 2017, online issue of Neurology®, the medical journal of the American Academy of Neurology.

“Virtual reality training may be a motivating alternative for people to use as a supplement to their standard therapy after a stroke,” said study author Iris Brunner, PhD, of Aarhus University, Hammel Neurocenter in Denmark. “Future studies could also look at whether people could use virtual reality therapy remotely from their homes, which could lessen the burden and cost of traveling to a medical center for standard therapy.” (more…)

Uninsured heart attack, stroke patients face ‘catastrophic’ costs

Nov 20, 2017

Heart attack and stroke patients without medical insurance face “devastating” health care costs that can bankrupt them, research from UT Southwestern and other centers shows.

“Many patients with large medical bills may have had to declare bankruptcy, sell their home, and be hounded by medical bill collectors as they struggled to juggle rent or mortgage payments while paying for utilities and food,” said cardiologist Dr. Rohan Khera, an Internal Medicine fellow at UT Southwestern Medical Center and co-first author of the paper, “Medical expenses are the leading cause of bankruptcy in the United States.” (more…)