Daily IV dornase alfa after a ruptured brain aneurysm to improve independence at six months.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.