NCT06409364 FLudrocortisone Administration in Aneurysmal Subarachnoid Haemorrhage
| NCT ID | NCT06409364 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | The George Institute |
| Condition | Aneurysmal Subarachnoid Hemorrhage |
| Study Type | INTERVENTIONAL |
| Enrollment | 524 participants |
| Start Date | 2025-08-13 |
| Primary Completion | 2029-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 524 participants in total. It began in 2025-08-13 with a primary completion date of 2029-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A multi-centre, prospective, blinded, randomised clinical trial of fludrocortisone compared with placebo in patients presenting with aneurysmal subarachnoid haemorrhage. The study aim is to determine if early administration of enteral fludrocortisone in aneurysmal subarachnoid haemorrhage reduce death and dependency at six months.
Eligibility Criteria
Inclusion Criteria: 1. Age 18 years or older 2. Diagnosed with subarachnoid haemorrhage from an aneurysm confirmed on computed tomography angiography (CTA) or digital subtraction angiography (DSA) of the intra-cranial arteries 3. Aneurysm has been secured 4. Hospital admission for aSAH within 96 hours 5. Currently being treated in a critical care environment Exclusion Criteria: 1. Unable to receive enteral medications 2. Pre-existing glucocorticoid or mineralocorticoid treatment 3. Previous allergic reaction to fludrocortisone 4. History of cardiac, hepatic, or renal failure 5. Hypernatremia or hyponatremia (Na\>145mmol/L or Na\<125mmol/L) on the most recent blood sample at the time of screening. 6. Death deemed imminent or inevitable 7. Pregnancy (confirmed or suspected) 8. Previous inclusion in the FLASH trial
Contact & Investigator
Jeremy Cohen, MBBS
PRINCIPAL INVESTIGATOR
Royal Brisbane Hospital, Brisbane, Australia
Frequently Asked Questions
Who can join the NCT06409364 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Aneurysmal Subarachnoid Hemorrhage. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06409364 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06409364 currently recruiting?
Yes, NCT06409364 is actively recruiting participants. Contact the research team at cohenjeremy@me.com for enrollment information.
Where is the NCT06409364 trial being conducted?
This trial is being conducted at New Lambton Heights, Australia, Penrith, Australia, Randwick, Australia, St Leonards, Australia and 11 additional locations.
Who is sponsoring the NCT06409364 clinical trial?
NCT06409364 is sponsored by The George Institute. The principal investigator is Jeremy Cohen, MBBS at Royal Brisbane Hospital, Brisbane, Australia. The trial plans to enroll 524 participants.