Safety and efficacy of administering the drug Tenecteplase into a cerebral artery after incomplete restoration of blood flow due to occlusions within the brain (TECNO)
Zusammenfassung der Studie
In some patients, after an occlusion of the large cerebral arteries, incomplete restoration of blood flow may occur due to small blood clot fragments. After the removal of these clot fragments, the additional administration of a thrombolytic drug (Tenecteplase) may be beneficial. Developing and testing therapies targeting small residual blood clot fragments after the removal of the large clot has a significant impact on the health future of patients. It is crucial whether they can live without disability after a stroke.
(BASEC)
Untersuchte Intervention
The aim of the study is to find out whether the administration of a thrombolytic drug (Tenecteplase) can dissolve these clot fragments and thus lead to better restoration of blood flow to the brain tissue and further reduction of the severity of the stroke. To pursue this goal, a total of 156 patients will be assigned in a 1:1 ratio either to the additional administration of Tenecteplase or to the current standard treatment (no further therapy). Improvement in blood flow restoration will be evaluated after 25 minutes and 24 hours after randomization. The severity of the stroke will be checked after 24 hours and after 90 days to see if brain damage could be reduced.
(BASEC)
Untersuchte Krankheit(en)
The most severe strokes caused by hypoperfusion are due to an occlusion of a large cerebral artery. Currently, the standard treatment for these patients involves the mechanical removal of the blood clot using special instruments introduced through the groin. While this treatment method is beneficial for many patients, the blood clot can only be partially removed in up to 40% of cases, leaving small clot fragments in the small cerebral arteries. This restoration of blood flow to the brain tissue, although improved compared to the initial situation, is incomplete and is associated with a reduced chance of complete recovery. Therefore, therapies that dissolve these small clot fragments are desirable.
(BASEC)
- Informed consent, age ≥ 18 years - Clinical signs indicating a sudden ischemic stroke - Patient had a first large vessel occlusion in the anterior circulation of the brain (defined as intracranial ICA, M1, M2, M3, A1, A2, P1 or P2) - The patient underwent stroke treatment within the vessels - Randomization no later than < 705 minutes (11h 45min) after symptom onset/last time the patient was healthy (BASEC)
Ausschlusskriterien
- Sudden bleeding in the skull - Non-applicability for magnetic resonance imaging (e.g., pacemaker) - Severe bleeding within the last 6 months - Major surgical procedures in the last 2 months - Oral intake of vitamin K antagonists (medication that displaces vitamin K and thus inhibits blood coagulation) with INR > 1.7 - Platelets < 50,000 - Uncontrolled hypertension (defined as SBP > 185 mmHg or DBP > 110 mmHg, which are not treatable) (BASEC)
Studienstandort
Basel, Bern, Genf, Lugano, St Gallen, Zürich
(BASEC)
Sponsor
Inselspital Bern
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Johannes Kaesmacher
+41 31 632 03 64
nctu@clutterinsel.chInselspital Bern Universitätsklinik für Neuroradiologie Freiburgstrasse 3010 Bern
(BASEC)
Wissenschaftliche Auskünfte
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Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Bern
(BASEC)
Datum der Bewilligung durch die Ethikkommission
28.06.2022
(BASEC)
ICTRP Studien-ID
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Offizieller Titel (Genehmigt von der Ethikkommission)
Safety and Efficacy of intra-arterial Tenecteplase for non-complete reperfusion of intracranial occlusions (BASEC)
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