DORNASE ALFA for Subarachnoid haemorrhage

Inclusion criteria

• {"criterion_text":"- Patient aged 18 or over\n- Hospital admission for subarachnoid haemorrhage (SAH) due to a ruptured aneurysm\n- Onset of SAH symptoms less than 48 hours old\n- Effective aneurysm exclusion within the last 24 hours\n- No complications during the exclusion procedure, confirmed on post-procedure CT scan\n- Fisher score > 1(présence of blood) on initial brain CT scan before aneurysm exclusion (first scan performed during emergency management)\n- Beneficiary of a social protection scheme\n- Informed consent signed : o By the patient or by a family member/trusted support person if the patient's condition does not allow them to express their consent in writing (L1111-6) o In an emergency situation and in the absence of family members or a trusted support person, the patient may be included. Consent to participate in the research will be sought as soon as the patient's condition allows him/her to express consent."}

Exclusion criteria

• {"criterion_text":"- Date of unidentified aneurysm rupture\n- Serious infections\n- Patient with renal insufficiency (GFR < 60ml/min/1.73m2 or serum creatinine >130 μmol/L\n- Immediate complications, neurosurgical or related to embolisation\n- Known hypersensitivity to dornase alfa, to Chinese hamster ovary cell products or to the excipients of this product. RESET_protocol_V1.0_Du 20240417 Research code: FDE-2023-11 EU-CTIS 2023-509627-40-00 10/59 product.\n- Previous disability (mRS>1 before SAH)\n- Pregnant or breast-feeding woman (negative urine pregnancy test for women aged 49 or under)\n- Adults subject to a legal protection measure (L1121-8) Persons deprived of their liberty by judicial or administrative decision, persons subject to psychiatric care under articles L3212-1 and L3123-1 and persons admitted to a health or social establishment for purposes other than research (L1121-6).\n- Participation in another interventional drug or medical device clinical trial in the 30 days prior to inclusion.\n- Rebleeding after admission confirmed by a second scan."}

Primary endpoints

• {"endpoint_text":"- Excellent functional prognosis defined by a score of 0 or 1 on the modified Rankin Scale (mRS) at 6 months. Assessment will be centralised and carried out by telephone by a certified professional, blinded to the randomisation arm.","definition_or_measurement_approach":"Centralised telephone assessment by a certified professional, blinded to the randomisation arm; endpoint = mRS score of 0 or 1 at 6 months."}

Secondary endpoints

• {"endpoint_text":"- Focal neurological deficit or decrease in Glasgow score (at least 2 points for at least 1 hour), not immediately after aneurysmal occlusion and not entirely related to another cause (verified by clinical, biological and radiological means), according to the SAHIT (Subarachnoid Hemorrhage International Trialists) definition.","definition_or_measurement_approach":"Per SAHIT definition; verification by clinical, biological and radiological means."}
• {"endpoint_text":"- Modified Rankin Scale (mRS) score at 6 months","definition_or_measurement_approach":"mRS assessed at 6 months (method for assessment not further detailed for this item beyond primary endpoint procedures)."}
• {"endpoint_text":"- Ischaemic lesions on MRI at D21 post-HSA (or at discharge if before D21). MRI scans will be analysed centrally by a radiologist blinded to the randomisation arm.","definition_or_measurement_approach":"MRI at D21 (or at discharge if earlier); scans analysed centrally by a blinded radiologist."}
• {"endpoint_text":"- Treatment of vasospasm defined by one of the following interventions: endovascular treatment or IV infusion of milrinone or increase in blood pressure by vasopressor drugs.","definition_or_measurement_approach":"Occurrence of specified interventions (endovascular treatment, IV milrinone, or vasopressor-induced BP increase) up to D21 (or discharge)."}
• {"endpoint_text":"- Number of days among the 21 days post-HSA (or discharge from hospital if before D21) with prescription of one or more of the treatments mentioned in criterion 4","definition_or_measurement_approach":"Count of days with prescription of the vasospasm treatments specified in criterion 4 during the 21-day post-HSA period (or until discharge)."}
• {"endpoint_text":"- MoCA-5min score at 6 months","definition_or_measurement_approach":"MoCA-5min cognitive assessment at 6 months."}
• {"endpoint_text":"- All-cause mortality at D21 (or at hospital discharge if before D21)","definition_or_measurement_approach":"All-cause mortality measured at day 21 or at discharge if earlier."}
• {"endpoint_text":"- Serious adverse event","definition_or_measurement_approach":"Incidence of serious adverse events as defined in study safety reporting procedures."}
• {"endpoint_text":"- Change in NETs blood concentration between sampling at inclusion and sampling at D21 (or at discharge if before D21).","definition_or_measurement_approach":"Laboratory measurement of NETs blood concentration at inclusion and at D21 (or discharge); change over time analyzed."}
• {"endpoint_text":"- Score on the Subarachnoid Haemorrhage-Specific Outcome Tool (SAHOT) scale at 6 months","definition_or_measurement_approach":"SAHOT score assessed at 6 months."}
• {"endpoint_text":"- Score on the Stroke Impact Scale-16 (SIS-16) at 6 months","definition_or_measurement_approach":"SIS-16 score assessed at 6 months."}

France

Earliest CTIS Part Ii Submission Date

12-09-2024

Latest Decision Or Authorization Date

25-03-2026

Processing Time Days

559

Number Of Sites

9

Number Of Participants

304

Primary sponsor

Full Name

Hopital Fondation Adolphe De Rothschild

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France