Evaluation of the efficacy of intra venous dornase alfa (Pulmozyme®) on arterial recanalization in post-thrombectomy angiography in patients managed for ischemic stroke with thrombolysis and eligible for thrombectomy: a single-center phase II trial.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Complete recanalisation defined by a revised TICI score of 2C or 3 (Appendix 1) on post-MT cerebral angiography. - If the TM procedure is completed before 1 hour after the start of the dornase alfa infusion and the revised TICI score is <3, a second post-MT angiography, 1 hour after the start of the dornase alfa infusion, will be performed to assess the TICI score for the primary endpoint.
研究概览
简要总结
To evaluate in patients managed for ischemic stroke by thrombolysis and eligible for thrombectomy, the efficacy of dornase alfa (Pulmozyme®) intravenous administration on arterial recanalization in post-thrombectomy angiography.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Study design
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Patient aged over 18
- •Ischaemic stroke due to proximal intracranial occlusion (internal carotid artery or middle cerebral artery in its M1 segment) isolated from the anterior circulation eligible for cerebral thrombectomy.
- •Transferred urgently to the NRI unit at the Fondation Adolphe de Rothschild Hospital for cerebral thrombectomy
- •Treated with intravenous thrombolysis (Alteplase or Tenecteplase) according to the 2021 recommendations of the European Stroke Organisation (ESO) with a bolus performed less than 90 minutes before inclusion
- •With a DWI-ASPECT score ≥ 5 on initial brain MRI
- •Having received complete information about the study and having signed a consent to participate in the study (if it is impossible to provide information and to obtain consent to participate from the person undergoing the research, the information and consent must be obtained from the trusted support person or a family member if present; by way of derogation, inclusion may be carried out by the doctor following an emergency inclusion procedure)
- •Member or beneficiary of a social security scheme
排除标准
- •Tandem occlusion defined by proximal intracranial occlusion associated with homolateral extracranial stenosis of the internal carotid artery (>90% stenosis or complete occlusion) on initial MRI
- •Intracranial occlusion with suspected underlying arterial stenosis on initial MRI
- •mRS score > 2
- •Patient benefiting from a legal protection measure
- •Women of childbearing age (15-49)
- •Known allergy to Dornase alfa (Pulmozyme®) or to one of its excipients.
- •Patients included in this study are not allowed to participate in other interventional clinical research
- •Secondary exclusion criteria: Patients who did not receive the experimental treatment. Excluded patients will be replaced
结局指标
主要结局
Complete recanalisation defined by a revised TICI score of 2C or 3 (Appendix 1) on post-MT cerebral angiography. - If the TM procedure is completed before 1 hour after the start of the dornase alfa infusion and the revised TICI score is <3, a second post-MT angiography, 1 hour after the start of the dornase alfa infusion, will be performed to assess the TICI score for the primary endpoint.
Complete recanalisation defined by a revised TICI score of 2C or 3 (Appendix 1) on post-MT cerebral angiography. - If the TM procedure is completed before 1 hour after the start of the dornase alfa infusion and the revised TICI score is <3, a second post-MT angiography, 1 hour after the start of the dornase alfa infusion, will be performed to assess the TICI score for the primary endpoint.
Complete recanalisation defined by a revised TICI score of 2C or 3 (Appendix 1) on post-MT cerebral angiography. - If the TM procedure is completed before 1 hour after the start of the dornase alfa infusion and the revised TICI score is 3, the immediate post-TM angiography will be used to assess the TICI score for the primary endpoint.
Complete recanalisation defined by a revised TICI score of 2C or 3 (Appendix 1) on post-MT cerebral angiography. - If the TM procedure is completed before 1 hour after the start of the dornase alfa infusion and the revised TICI score is 3, the immediate post-TM angiography will be used to assess the TICI score for the primary endpoint.
Complete recanalisation defined by a revised TICI score of 2C or 3 (Appendix 1) on post-MT cerebral angiography. - If the duration of the TM procedure is > 1 hour after the start of the dornase alfa infusion, the immediate post-TM angiogram will be used to assess the TICI score for the primary endpoint.
Complete recanalisation defined by a revised TICI score of 2C or 3 (Appendix 1) on post-MT cerebral angiography. - If the duration of the TM procedure is > 1 hour after the start of the dornase alfa infusion, the immediate post-TM angiogram will be used to assess the TICI score for the primary endpoint.
次要结局
- Early recanalisation defined by a revised TICI score of 2b, 2c or 3 on pre-thrombectomy cerebral angiography
- Improvement of at least one grade in the revised TICI score between cerebral angiography after the last pass of TM and that performed 1 hour after the start of the dornase alfa infusion (for TM procedures <1 hour)
- Duration of thrombectomy procedure defined by the time (in minutes) between arterial puncture and recanalisation
- Number of thrombectomy operations
- Intra-procedural ENT defined by the appearance on cerebral angiography of arterial occlusion in an initially unaffected territory during or at the end of mechanical thrombectomy
- Cerebral infarct volume measured on cerebral MRI between 24 and 36 hours after thrombolysis
- Haemorrhagic transformation assessed on a brain scan at 24-36 hours using the ECASS 3 scale (Appendix 2)
- Decrease in NIHSS score (Appendix 3) > 8 points between the pre-thrombolysis score and the score 24-36 hours after thrombectomy
- Favourable functional prognosis at 3 months defined by a modified Rankin score of less than 3 (Appendix 4)
- All-cause death 3 months after ischaemic stroke
- Changes in concentrations of thrombolysis blood markers (D-dimers, plasmin-antiplasmin complex, DNAse, fibrinogen degradation products, free DNA) between : before Pulmozyme administration (sample taken when the patient arrived in the NRI unit) and after administration (sample taken at the end of thrombectomy)
- Adverse events and serious/non-serious adverse reactions
研究者
Clinical Research Department
Scientific
Fondation A De Rothschild