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Efficacy of daily IV administration of dornase alfa for up to 14 days post subarachnoid haemorrhage on functional independence at 6 months: a multicentre open-label randomised controlled trial of the PROBE type Probe
EU CTIS ID: 2023-509627-40-01
What this study is testing
EValuate the efficacy of a daily IV infusion of dornase alfa (125 microg/kg) up to D14 post-HSA on the occurrence of an excellent functional prognosis at 6 months.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patient aged 18 or over
- Hospital admission for subarachnoid haemorrhage (SAH) due to a ruptured aneurysm
- Onset of SAH symptoms less than 48 hours old
- Effective aneurysm exclusion within the last 24 hours
- No complications during the exclusion procedure, confirmed on post-procedure CT scan
- Fisher score > 1(présence of blood) on initial brain CT scan before aneurysm exclusion (first scan performed during emergency management)
You likely can't join if
- Date of unidentified aneurysm rupture
- Rebleeding after admission confirmed by a second scan.
- Serious infections
- Patient with renal insufficiency (GFR < 60ml/min/1.73m2 or serum creatinine >130 μmol/L
- Immediate complications, neurosurgical or related to embolisation
- 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.
See the full eligibility criteria
- Patient aged 18 or over
- Hospital admission for subarachnoid haemorrhage (SAH) due to a ruptured aneurysm
- Onset of SAH symptoms less than 48 hours old
- Effective aneurysm exclusion within the last 24 hours
- No complications during the exclusion procedure, confirmed on post-procedure CT scan
- Fisher score > 1(présence of blood) on initial brain CT scan before aneurysm exclusion (first scan performed during emergency management)
- Beneficiary of a social protection scheme
- 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.
- Date of unidentified aneurysm rupture
- Rebleeding after admission confirmed by a second scan.
- Serious infections
- Patient with renal insufficiency (GFR < 60ml/min/1.73m2 or serum creatinine >130 μmol/L
- Immediate complications, neurosurgical or related to embolisation
- 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.
- Previous disability (mRS>1 before SAH)
- Pregnant or breast-feeding woman (negative urine pregnancy test for women aged 49 or under)
- 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).
- Participation in another interventional drug or medical device clinical trial in the 30 days prior to inclusion.
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.