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Strokes are a major health problem in Europe, affecting approximately 1.5 million people each year. Of those patients, 10-15 % suffer from very severe strokes that can have devastating impacts on their lives, with very low chances of recovery. Currently, no medical intervention procedures are available to patients with severe strokes, but an EU-funded project is looking to test a treatment that could change that.
Patients suffering from less severe strokes often undergo a thrombectomy – a procedure that involves extracting a blood clot in the brain via a catheter. The treatment can be very effective in reopening the blocked brain vessels, saving patients from long-lasting disability. Researchers in the EU-funded TENSION project are carrying out a clinical trial in which they are applying thrombectomy procedures to severe stroke patients in 40 medical centres across 8 countries. This is the first time such an extensive and representative trial of this treatment has been conducted.
‘Today, the fear is that a thrombectomy might cause a brain haemorrhage or be unsuccessful in patients who already show extended stroke lesions, so it is usually not offered to these stroke patients,’ says TENSION project coordinator Götz Thomalla, senior physician at the University Hospital Hamburg-Eppendorf, Germany. ‘However, we believe that it could be effective, even in very severe stroke patients there’s a potential great benefit, so we are undertaking trials to test this theory.’
Removing blood clots
A large percentage of strokes are caused by a blood clot in the brain that deprives parts of the brain of oxygen, preventing them from working. A thrombectomy can remove the clot by inserting a catheter into the arteries of the brain from the groin and, using X-ray control, removing the clot with high-precision instruments. The procedure must be carried out as soon as possible following a stroke to prevent brain cells from dying.
The TENSION trial is randomised, which means half of the patients in the trial receive the thrombectomy treatment while the other half receive standard stroke care but no interventional procedure. After 90 days, the level of the patient’s disability related to the stroke is assessed using the Modified Rankin scale – a widely used tool to measure the level of dependence in a patient’s daily activities.
If successful, the treatment would improve the quality of life for people who have had severe strokes, while reducing the social and economic cost of caring for them.
Early phases
‘We hope that, based on data from previous but less-extensive patient trials, this treatment will be beneficial, creating impacts that will reduce the chances of disabilities and death following a severe stroke,’ says Thomalla. ‘Thrombectomies have so far proven to be very effective in patients with small strokes and we feel that this could apply to patients with severe strokes, too.’TENSION is currently in its early phases, with 38 patients included at about one-third of the partner medical centres. It will roll out to up to 714 patients during its 5-year trial period.