BridgeMD
Tests treatment safety and results for Ruptured Aneurysm of Intracranial Artery
Official title Efficacy of Daily IV Administration of Dornase Alfa up to 14 Days Post Subarachnoid Hemorrhage on Functional Independence at 6 Months
ClinicalTrials.gov ID: NCT06723717
What this study is testing
What is Daily infusion of dornase alfa?
Daily infusion of dornase alfa is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for ruptured aneurysm of intracranial artery.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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)
You likely can't join if
- Unidentified date of aneurysm rupture / rebleeding
- Severe infections
- Patient with impaired renal function (GFR \ 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)
See the full eligibility 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)
- Unidentified date of aneurysm rupture / rebleeding
- Severe infections
- Patient with impaired renal function (GFR \ 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 treatment drug or medical device clinical trial within the 30 days prior to inclusion.
The study team makes the final eligibility decision.
Where it's taking place
- Grenoble, Grenoble, France
- Lyon, Lyon, France
- Montpellier, Montpellier, France
- Poitiers, Poitiers, France
- Strasbourg, Strasbourg, France
- Suresnes, Île-de-France Region, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Grenoble, Grenoble, France; Lyon, Lyon, France; Montpellier, Montpellier, France; Poitiers, Poitiers, France; Strasbourg, Strasbourg, France; Suresnes, Île-de-France Region, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.