Daily IV dornase alfa after a ruptured brain aneurysm to improve independence at six months.
Efficacy of Daily IV Administration of Dornase Alfa up to 14 Days Post Subarachnoid Hemorrhage on Functional Independence at 6 Months: a PROBE Multicenter Open-label Randomized Controlled Trial
This test will try daily intravenous dornase alfa in people with aneurysmal subarachnoid hemorrhage to see if it helps them be more functionally independent at six months.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 304 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondation Ophtalmologique Adolphe de Rothschild Research network |
| Locations | 6 sites (Grenoble, Grenoble and 5 other locations) |
| Trial ID | NCT06723717 on ClinicalTrials.gov |
What this trial studies
This Phase 2 interventional protocol gives daily intravenous dornase alfa for up to 14 days to patients hospitalized after aneurysmal subarachnoid hemorrhage, aiming to reduce delayed cerebral ischemia (DCI). Eligible patients must have symptom onset within 48 hours, aneurysm exclusion secured within the prior 24 hours without immediate complications, and a Fisher score >1 on the initial CT. The primary focus is functional independence at six months, with the intervention timed to cover the period when DCI most commonly occurs (days 4–14). The trial is conducted at university hospitals in Grenoble, Lyon, and Montpellier, France.
Who should consider this trial
Good fit: Ideal candidates are adults hospitalized for aneurysmal SAH with symptom onset under 48 hours, an aneurysm secured within 24 hours without complications, a Fisher score >1, normal renal function, not pregnant or breastfeeding, and no prior significant disability.
Not a fit: Patients with unknown rupture timing or rebleeding, severe infections, significant renal impairment, immediate post-procedural complications, prior disability, pregnancy or recent participation in another interventional trial are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the treatment could reduce delayed cerebral ischemia and increase the number of patients who regain functional independence at six months.
How similar studies have performed: Using intravenous dornase alfa for DCI is largely novel with very limited clinical data, whereas existing DCI treatments like nimodipine or hemodynamic measures have shown only modest and variable benefits.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Grenoble, Grenoble and 5 other locations
- CHU de Grenoble — Grenoble, Grenoble, France (Recruiting)
- HCL de Lyon — Lyon, Lyon, France (Recruiting)
- CHU de Montpellier — Montpellier, Montpellier, France (Recruiting)
- CHU Poitiers — Poitiers, Poitiers, France (Recruiting)
- CHU Strasbourg — Strasbourg, Strasbourg, France (Recruiting)
- Hôpital FOCH — Suresnes, Île-de-France Region, France (Recruiting)
Study contacts
- Principal investigator: Francois Delvoye, MD — Hôpital Fondation Adolphe de Rothschild
- Study coordinator: Amelie Yavchitz
- Email: ayavchitz@for.paris
- Phone: +33148036454
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.