Research project led by the UKE: Clinical Trial in eight European countries has started

When stroke is treated by thrombectomy, blood clots are removed from the arteries of the brain with the help of a catheter in order to rebuild the blood circulation in the damaged area. So far, this therapy is only used regularly in specialized centres if the stroke had not already casued significant damage to the brain.

The research project TENSION, under the leadership of researchers of the Universitätsklinikum Hamburg-Eppendorf (UKE), will show whether patients affected by a severe stroke with already extended brain damage can also benefit from this treatment. In close collaboration with the Universitätsklinikum Heidelberg, the study has now started at 40 locations in eight countries. The project is funded by the European Union with a 6 million Euro grant.

Most strokes are caused by a blood clot (thrombus) which blocks a blood vessel in the brain so that parts of the brain can no longer be supplied with oxygen. The longer the vascular obliteration continues, the more brain tissue dies. Blood clots obstructing large brain arteries can be removed by endovascular treatment by introduction of a catheter starting from the groin into the arteries of the brain. This treatment, which is called thombectomy, is effective and has become standard of care for patients in whom only a few brain tissues are injured. Under these circumstances, patients have very good chances to live an independent and unimpeded life after a stroke. Whether this treatment can also help patients with severe strokes with already extended brain damage is still unclear. Therefore, these patients are currently not treated with thrombectomy in routine clinical practice.

“With our research project, TENSION, we aim to prove that patients with already extended lesions can also benefit from thrombectomy”, says Prof. Dr. Götz Thomalla, project Coordinator and lead-ing senior physician in the Clinic for Neurology of the UKE. “If our assumptions are true, the trial will provide evidence for effective treatment for a large number of patients with severe stroke and already extended brain damage.“

Clinical Study: 40 study sites, 714 patients

In the clinical trial, up to 714 patients who are admitted to a hospital with a stroke in one of the 40 trial sites will be enrolled. A criterion for inclusion in the study is that brain imaging should have already shown an extended area of damaged brain tissue around the affected blood vessel. Evalu-ation of the extent of the lesion will come from imaging techniques such as computed tomography and magnetic resonance tomography. “The correct evaluation of CT and MR images by the treating physician plays a crucial role here”, says Prof. Dr. Jens Fiehler, director of the Clinic of Neuroradiology at UKE and leader of the image core lab of the TENSION study and adds: “In order to guarantee a consistently high quality of image reading in all study sites, we have developed standardized training that must be passed all physicians who participate in the trial.”

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Patients are randomly divided into two groups by: Both groups will receive normal medicinal therapy, but in addition, the second group will also have the clot removed by thrombectomy. After 90 days, the stroke patient’s degree of residual disability will be ranked by means of the usual scales used in stroke treatment. “The TENSION trial will answer the most urgent clinical question concern-ing the use of thrombectomy for treatment of stroke”, says Prof. Bendszus, Head of the Department of Neuroradiology at the University Hospital Heidelberg and Coordinating Investigator of the trial. “Such an interdisciplinary effort will also help us to improve the access to this effective treatment across Europe.”

The Clinical Trial is coordinated by the Universitätsklinikum Heidelberg, while the overall research project TENSION is led by the UKE.

Contact

Prof. Dr. Götz Thomalla
Klinik und Poliklinik für Neurologie
Universitätsklinikum Hamburg-Eppendorf (UKE)
Martinistr. 52
20246 Hamburg
Phone: 040 7410- 50137
thomalla@uke.de

Prof. Dr. Martin Bendszus
University Hospital of Heidelberg
Department of Neuroadiology
Im Neuenheimer Feld 400
69120 Heidelberg
Phone: +49 6221-56-7566
martin.bendszus@med.uni-heidelberg.de

Prof. Dr. Jens Fiehler
Klinik für Neuroradiologische Diagnostik und Intervention
Universitätsklinikum Hamburg-Eppendorf (UKE)
Martinistr. 52
20246 Hamburg
Phone: 040 7410- 55598
fiehler@uke.de