FLudrocortisone Administration in Aneurysmal Subarachnoid Haemorrhage

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Aneurysmal Subarachnoid Hemorrhage

In brief

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.

Key facts

Study ID

NCT06409364

Run by

The George Institute

People needed

524

Starts

2025-08-13

Expected to finish

2030-07-31

Last updated by the study team

2025-12-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 years or older
• Diagnosed with subarachnoid haemorrhage from an aneurysm confirmed on computed tomography angiography (CTA) or digital subtraction angiography (DSA) of the intra-cranial arteries
• Aneurysm has been secured
• Hospital admission for aSAH within 96 hours
• Currently being treated in a critical care environment

You may not qualify if…

• Unable to receive enteral medications
• Pre-existing glucocorticoid or mineralocorticoid treatment
• Previous allergic reaction to fludrocortisone
• History of cardiac, hepatic, or renal failure
• Hypernatremia or hyponatremia (Na>145mmol/L or Na<125mmol/L) on the most recent blood sample at the time of screening.
• Death deemed imminent or inevitable
• Pregnancy (confirmed or suspected)
• Previous inclusion in the FLASH trial

Where it is running

• Nepean Hospital — Penrith, New South Wales, Australia (enrolling)
• Gold Coast University Hospital — Gold Coast, Queensland, Australia (enrolling)
• Royal North Shore Hospital — St Leonards, New South Wales, Australia
• Westmead Hospital — Westmead, New South Wales, Australia
• Wollongong Hospital — Wollongong, New South Wales, Australia
• Royal Brisbane Women's Hospital — Brisbane, Queensland, Australia
• Townsville Hospital — Townsville, Queensland, Australia
• Princess Alexandra Hospital — Woolloongabba, Queensland, Australia
• Royal Hobart Hospital — Hobart, Tasmania, Australia
• Monash Medical Centre — Clayton, Victoria, Australia
• St Vincent's Hospital (Melbourne) — Fitzroy, Victoria, Australia
• The Alfred Hospital — Melbourne, Victoria, Australia
• Auckland City Hospital — Auckland, New Zealand
• John Hunter Hospital — New Lambton Heights, New South Wales, Australia
• Wellington Hospital — Wellington, New Zealand
• Prince of Wales Hospital — Randwick, New South Wales, Australia

Full record on ClinicalTrials.gov

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