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FLudrocortisone Administration in Aneurysmal Subarachnoid Haemorrhage

ConditionAneurysmal Subarachnoid Hemorrhage
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe George Institute

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Unable to receive enteral medications

Pre-existing glucocorticoid or mineralocorticoid treatment

Previous allergic reaction to fludrocortisone

History of cardiac, hepatic, or renal failure

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fludrocortisone

    Drug

    small white tablet containing 100mcg of fludrocortsone

  • Placebo

    Drug

    Matched placebo tablet,

Treatment groups

524 Participants
are divided into 2 treatment groups
Group A: Study drugExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Modified Rankin Scale

The primary outcome measure will be the modified Rankin Scale (mRS) score. Scores range from 0-5 with 0 is no disability and 5 is severe.

Time frame
Six months after randomisation

Secondary outcomes

1

Subarachnoid Haemorrhage Outcome Tool (SAHOT)

The secondary outcome measure will be the Subarachnoid Haemorrhage Outcome Tool (SAHOT) score. Fifty-six questions, possible score 0-2, maximum total score = 112.

Time frame
Six months after randomisation

Other outcomes

1

mortality

90-day mortality

Time frame
90 days
2

Major disability or death (Modified Rankin Score (mRS) or >=3)

Major disability or death at day 90 (mRS\>=3). Scores range from 0-5 with 0 is no disability and 5 is severe. to meet this outcome the mRS \>=3.

Time frame
90 days
3

Days alive and free of ICU

Days alive and free of ICU Days alive and free of ICU from randomisation to 90 days

Time frame
90 days
4

Days alive and at home

Number of days alive and free of ICU

Time frame
90 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The George Institute

Lead sponsor

Source ClinicalTrials.gov
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