cerebral thrombectomy
Conditions
Interventions
Trade Name: DORNASE ALFA
Pharmaceutical Form: Inhalation solution
Sponsors
Hôpital Fondation A. de Rothschild / Service de recherche clinique
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient over 18 years of age 2. Ischemic stroke by proximal intracranial occlusion (internal carotid artery, middle cerebral artery in its M1 or M2 segment) isolated from the anterior circulation eligible for cerebral thrombectomy. 3. Transferred to the NRI block of Hôpital Fondation A. de Rothschild as an emergency for a cerebral thrombectomy. 4. Treated with IV thrombolysis (Aleplase or Tenecteplase) according to the European Stroke Organisation (ESO) 2021 guidelines with a bolus performed less than 90 minutes before inclusion. 5. With a DWI-ASPECT score = 5 on initial brain MRI 6. Having received informed information about the study and consent to participate in the trial (if it is impossible to provide the information and to obtain consent to participate from the person consenting to the research, the information and the consent must be obtained from the trusted person or a family member if present, by way of exception, the inclusion may be made by the doctor following an emergency inclusion procedure). 7. Member or beneficiary of a social health assurance Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 22 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 22
Exclusion criteria
Exclusion criteria: 1. Patient benefiting from a legal protection measure 2. Pregnant or breastfeeding woman 3. Known allergy to Dornase alfa (Pulmozyme®) or one of its excipients. 4. Patients included in this study are not allowed to participate in other interventional clinical research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the efficacy of intravenous administration of dornase alfa (Pulmozyme®) on arterial recanalization in post-thrombectomy angiography in patients managed for ischemic stroke by thrombolysis and eligible for thrombectomy;Secondary Objective: To evaluate in patients managed for ischemic stroke by thrombolysis and eligible for thrombectomy, the efficacy of IV administration of dornase alfa on : 1. The rate of early recanalisation in pre-thrombectomy angiography 2. Improvement in the recanalisation rate between the last pass of TM and one hour after dornase alfa administration (for TM procedures 1h). ;Timepoint(s) of evaluation of this end point: day 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Early recanalisation defined by a score of TICI 2b, 2c or 3 on pre-thrombectomy cerebral angiography 2. Improvement of at least one grade in TICI score between cerebral angiography after the last pass of TM and that performed 1h after the start of dornase alfa infusion (for TM procedures 8 points between the pre-thrombolysis score and the score at 24-36h after thrombectomy 9. Favourable functional prognosis at 3 months defined by a modified Rankin score of less than 3 (Appendix 4) 10. All-cause death at 3 months after ischaemic stroke. 11. Changes in blood thrombolysis marker concentrations (D-dimer, plasmin-antiplasmin complex, DNAse, fibrinogen degradation products, free DNA) between before Pulmozyme administration (sample taken on arrival of the patient in the NRI block) and after administration (sample taken at the end of the thrombectomy) 12. Adverse events and serious/non-serious adverse reactions. ;Timepoint(s) of evaluation of this end point: day 1 and month 3 | — |
Countries
France
Contacts
Public ContactAdministrative Coordinator
Hôpital Fondation A. de Rothschild / Service de recherche clinique
Outcome results
None listed