FLudrocortisone Administration in Aneurysmal Subarachnoid Haemorrhage

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.

Conditions

• Aneurysmal Subarachnoid Hemorrhage

Interventions

DRUG

Fludrocortisone

small white tablet containing 100mcg of fludrocortsone

DRUG

Placebo

Matched placebo tablet,

Sponsors & Collaborators

• The George Institute

  lead OTHER

Principal Investigators

• Jeremy Cohen, MBBS · Royal Brisbane Hospital, Brisbane, Australia

• Anthony Delaney, MBBS · Royal North Shore Hospital, Sydney, Australia

• Torg Westerlund, MBBS · John Hunter Hospital, Newcastle, Australia

• Andrew Udy, BHB MB ChB · The Alfred Hospital, Melbourne, Australia

• Alex Nesbitt, MBBS · Princess Alexandra Hospital

• Ian Sepppelt, MBBS · Nepean Blue Mountains Local Health District

• Mak Wei-Yun, MBBS · Monash Medical Centre

• David Bowen, MBBS · Westmead Hospital

• James McCulloch, MBChB · Gold Coast University Hospital

• Humphrey Walker, MBBS · St Vincent's Hospital Melbourne

• Sananta Dash, MBBS · Townsville University Hospital

• Matthew MacPartlin, MBBS · Wollongong Hospital

• Andrew Turner, MBBS · Royal Hobart Hospital

• Gavin Salt, MBBS · Prince of Wales Hospital

• Laura Tincknell, MBBS · Auckland City Hospital

• Jason Wright, MBBS · Wellington City Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-08-13

Primary Completion

2029-07-31

Completion

2030-07-31

Countries

• Australia
• New Zealand

Study Locations