Fludrocortisone for adults with aneurysmal subarachnoid hemorrhage

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicentre, prospective, randomized, blinded, placebo-controlled Phase 2 trial comparing enteral fludrocortisone with placebo in adults with aneurysmal subarachnoid hemorrhage whose aneurysm has been secured. Participants are enrolled within 96 hours of hospital admission and receive the study drug while treated in a critical care environment, with outcomes including death and dependency at six months. Key exclusions include inability to receive enteral medication, pre-existing glucocorticoid or mineralocorticoid therapy, significant cardiac/hepatic/renal failure, abnormal sodium, pregnancy, or imminent death. The trial is being run at three tertiary hospitals in New South Wales, Australia.

Why it matters

Who can join: the full rules

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

Where it's running

• Nepean Hospital
  Penrith, New South Wales, Australia Recruiting
• Gold Coast University Hospital
  Gold Coast, Queensland, Australia Recruiting
• John Hunter Hospital
  New Lambton Heights, New South Wales, Australia Not yet recruiting
• Prince of Wales Hospital
  Randwick, New South Wales, Australia Not yet recruiting
• Royal North Shore Hospital
  St Leonards, New South Wales, Australia Not yet recruiting
• Westmead Hospital
  Westmead, New South Wales, Australia Not yet recruiting

Study contacts

• Principal investigator: Jeremy Cohen, MBBS — Royal Brisbane Hospital, Brisbane, Australia
• Study coordinator: Jeremy Cohen, MBBS
• Email: cohenjeremy@me.com
• Phone: +610732327000

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Nitric Oxide Use to Predict Vasospasm in Aneurysmal Subarachnoid Hemorrhage

  This study tests whether nitric oxide consumption in CSF can predict cerebral vasospasm in patients with aneurysmal SAH.

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• Multi-omics program to understand complications and outcomes after aneurysmal subarachnoid hemorrhage

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• Dome-only coiling for severe aneurysmal subarachnoid hemorrhage

  This will test a minimally invasive dome-protection coiling procedure to prevent re-bleeding in adults who have had a severe aneurysmal subarachnoid hemorrhage.

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• Cilostazol to help prevent delayed brain ischemia after aneurysm bleed

  This study tests whether cilostazol can reduce delayed brain ischemia and improve outcomes after aneurysmal subarachnoid hemorrhage in adults who had recent aneurysm treatment.

  Recruiting Phase 3 Beijing Tiantan Hospital · Beijing, Beijing Municipality · NCT07249853

• Transcutaneous Vagal Nerve Stimulation to help with brain vessel narrowing after aneurysm rupture

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• Tocilizumab-aazg to reduce stroke risk after a ruptured brain aneurysm

  This trial will try to see if a single IV dose of tocilizumab-aazg is safe and can help prevent delayed strokes in adults who have had a ruptured brain aneurysm (aneurysmal subarachnoid hemorrhage).

  Recruiting Phase 1 University of Florida · Gainesville, Florida · NCT06863480

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.