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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

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-509627-40-01
Enrollment
314
Registered
2024-10-31
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

subarachnoid hemorrhage

Brief summary

Excellent functional prognosis defined by a score of 0 or 1 on the modified Rankin Scale (mRS) at 6 months. Assessment will be centralised and carried out by telephone by a certified professional, blinded to the randomisation arm.

Detailed description

Focal neurological deficit or decrease in Glasgow score (at least 2 points for at least 1 hour), not immediately after aneurysmal occlusion and not entirely related to another cause (verified by clinical, biological and radiological means), according to the SAHIT (Subarachnoid Hemorrhage International Trialists) definition., Modified Rankin Scale (mRS) score at 6 months, Ischaemic lesions on MRI at D21 post-HSA (or at discharge if before D21). MRI scans will be analysed centrally by a radiologist blinded to the randomisation arm., Treatment of vasospasm defined by one of the following interventions: endovascular treatment or IV infusion of milrinone or increase in blood pressure by vasopressor drugs., Number of days among the 21 days post-HSA (or discharge from hospital if before D21) with prescription of one or more of the treatments mentioned in criterion 4, MoCA-5min score at 6 months, All-cause mortality at D21 (or at hospital discharge if before D21), Serious adverse event, Change in NETs blood concentration between sampling at inclusion and sampling at D21 (or at discharge if before D21).

Interventions

Sponsors

Hopital Fondation Adolphe De Rothschild
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Excellent functional prognosis defined by a score of 0 or 1 on the modified Rankin Scale (mRS) at 6 months. Assessment will be centralised and carried out by telephone by a certified professional, blinded to the randomisation arm.

Secondary

MeasureTime frame
Focal neurological deficit or decrease in Glasgow score (at least 2 points for at least 1 hour), not immediately after aneurysmal occlusion and not entirely related to another cause (verified by clinical, biological and radiological means), according to the SAHIT (Subarachnoid Hemorrhage International Trialists) definition., Modified Rankin Scale (mRS) score at 6 months, Ischaemic lesions on MRI at D21 post-HSA (or at discharge if before D21). MRI scans will be analysed centrally by a radiologist blinded to the randomisation arm., Treatment of vasospasm defined by one of the following interventions: endovascular treatment or IV infusion of milrinone or increase in blood pressure by vasopressor drugs., Number of days among the 21 days post-HSA (or discharge from hospital if before D21) with prescription of one or more of the treatments mentioned in criterion 4, MoCA-5min score at 6 months, All-cause mortality at D21 (or at hospital discharge if before D21), Serious adverse event, Change

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026