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Efficacy of Daily IV Administration of Dornase Alfa up to 14 Days Post Subarachnoid Hemorrhage on Functional Independence at 6 Months

RecruitingPhase 2Ages 18 Years - anyAllFondation Ophtalmologique Adolphe de Rothschild
NCT06723717 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Subarachnoid hemorrhage due to aneurysm rupture (SAH) results in high mortality, while survivors frequently suffer reduced quality of life and even loss of autonomy, particularly in the active population. A significant proportion of this morbidity and mortality is linked to the occurrence of delayed cerebral ischemia (DCI), defined as a new focal neurological deficit or reduced level of consciousness unrelated to the treatment of the aneurysm or a concomitant condition. DCI mainly occurs between days 4 and 14 after SAH, with an estimated incidence of 30%, and is significantly associated with an unfavorable functional prognosis at 3 months. Currently, the only treatment for post-SAH DCI is to prevent or reverse the onset of vasospasm, with limited efficacy, for example through nimodipine administration or hemodynamic optimization. However, according to existing data, vasospasm is not the

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📋 Eligibility rules (as published)
Inclusion Criteria: * Hospitalization for subarachnoid hemorrhage (SAH) due to aneurysm rupture * Onset of SAH symptoms less than 48 hours old * Aneurysm exclusion performed within the last 24 hours * No complications during exclusion procedure, confirmed on post-procedure CT scan * Fisher score \> 1 on initial brain CT scan prior to exclusion (first scan performed during emergency management) Exclusion Criteria: * Unidentified date of aneurysm rupture / rebleeding * Severe infections * Patient with impaired renal function (GFR \< 60ml/min/1.73m2 or serum creatinine \>1.5 mg/dL) * Immediate complications of neurosurgical intervention or embolization * Known hypersensitivity to dornase alfa, Chinese hamster ovary cell products or product excipients. * Previous disability (mRS\>1 prior to SAH) * Pregnant or breast-feeding women (negative urine pregnancy test for women aged 49 or under) * Participation in another interventional drug or medical device clinical trial within the 30 days prior to inclusion.
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What it tests

  • Daily infusion of dornase alfa
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Where

6 sites
CHU de Grenoble
Grenoble, France
HCL de Lyon
Lyon, France
CHU de Montpellier
Montpellier, France
CHU Poitiers
Poitiers, France
CHU Strasbourg
Strasbourg, France
Hôpital FOCH
Suresnes, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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