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New treatment option for Aneurysmal Subarachnoid Hemorrhage
Official title FLudrocortisone Administration in Aneurysmal Subarachnoid Haemorrhage
ClinicalTrials.gov ID: NCT06409364
What this study is testing
What is Fludrocortisone?
Fludrocortisone is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for aneurysmal subarachnoid hemorrhage.
Also referred to as Flurinef.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age 18 years or older
- Diagnosed with subarachnoid haemorrhage from an aneurysm confirmed on computed tomography angiography (CTA) or digital subtraction angiography (DSA)...
- Aneurysm has been secured
- Hospital admission for aSAH within 96 hours
- Currently being treated in a critical care environment
You likely can't join 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
See the full eligibility criteria
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- New Lambton Heights, New South Wales, Australia
- Penrith, New South Wales, Australia
- Randwick, New South Wales, Australia
- St Leonards, New South Wales, Australia
- Westmead, New South Wales, Australia
- Wollongong, New South Wales, Australia
- Brisbane, Queensland, Australia
- Gold Coast, Queensland, Australia
- Townsville, Queensland, Australia
- Woolloongabba, Queensland, Australia
- Hobart, Tasmania, Australia
- Clayton, Victoria, Australia
- Fitzroy, Victoria, Australia
- Melbourne, Victoria, Australia
- Auckland, New Zealand
- Wellington, New Zealand
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Lambton Heights, New South Wales, Australia; Penrith, New South Wales, Australia; Randwick, New South Wales, Australia; St Leonards, New South Wales, Australia; Westmead, New South Wales, Australia; Wollongong, New South Wales, Australia and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.