Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000072516
Ethics application status
Approved
Date submitted
19/12/2023
Date registered
29/01/2024
Date last updated
29/01/2024
Date data sharing statement initially provided
29/01/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Australian IntraCranial Haemorrhage Registry - a registry study to assess the clinical management and adherence to national treatment guidelines for adults who have experienced bleeding in the brain.
Scientific title
Australian IntraCranial Hemorrhage Registry - A study to assess current management, adherence to national guidelines and patient outcomes in adults who have suffered an intracranial hemorrhage, including spontaneous non-traumatic intracerebral hemorrhage, non-penetrative traumatic hemorrhage, and anticoagulant-associated intracranial hemorrhage.
Secondary ID [1] 311213 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
AustrICH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intracranial Haemorrhage 332402 0
Condition category
Condition code
Stroke 329101 329101 0 0
Haemorrhagic

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
5
Target follow-up type
Years
Description of intervention(s) / exposure
The exposure of interest are adult patients with intracranial hemorrhage. We will assess current management, including adherence to national guidelines, and outcomes in patients with intracranial hemorrhage. Data is collected within the first 24 hours of hospital presentation, day 7 and day 30, including vital signs, medications, neurological assessments and radiological imaging. Patient outcomes will be monitored biannually over 5 years via phone call. They will be asked questions about daily activities and independence, as well as complete a verbal questionnaire to assess Quality of life.
Intervention code [1] 327671 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336919 0
Established Blood Pressure Target
Timepoint [1] 336919 0
The first time the blood pressure target is achieved will be recorded. Blood pressure at 60 minutes after diagnostic radiological imaging will be recorded. Blood pressure will be recorded hourly for 24 hours, then at day 7, day 30 and day 90.
Primary outcome [2] 336920 0
Door to Time of Anticoagulant Reversal Agent Administration
Timepoint [2] 336920 0
Assessed within the first 24 hours of hospital presentation
Primary outcome [3] 336921 0
Proportion of participants with symptomatic haematoma expansion
Timepoint [3] 336921 0
24 hours after enrolment
Secondary outcome [1] 430170 0
Functional Outcomes after intracranial hemorrhage
Timepoint [1] 430170 0
Day 30 & Day 90
Secondary outcome [2] 430171 0
Quality of Life after intracranial hemorrhage
Timepoint [2] 430171 0
Day 90
Secondary outcome [3] 430611 0
Primary Outcome: Door to time of antihypertensive agent administration
Timepoint [3] 430611 0
Assessed within the first 24 hours
Secondary outcome [4] 430612 0
Cognitive Capacity after intracranial hemorrhage
Timepoint [4] 430612 0
Day 90

Eligibility
Key inclusion criteria
1. Age 18 years or older
2. Radiographically confirmed intracranial hemorrhage (intracerebral,
intraventricular, subarachnoid or subdural) either spontaneous or
secondary
3. If SDH or SAH, patients must also be currently treated with an OAC
(VKA, rivaroxaban, apixaban, dabigatran).
4. Time from symptom onset (or last known well) less than 24 hours prior to
the baseline imaging scan.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Penetrating intracranial injury (other traumatic intracranial
haemorrhage is eligible).
2. Haemorrhagic transformation of an ischaemic infarct.
3. Haemorrhage secondary to cerebral venous sinus thrombosis.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
13/12/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1500
Accrual to date
11
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment outside Australia
Country [1] 26043 0
Korea, Republic Of
State/province [1] 26043 0

Funding & Sponsors
Funding source category [1] 315472 0
Government body
Name [1] 315472 0
National Health and Medical Research Council (NHMRC)
Country [1] 315472 0
Australia
Primary sponsor type
University
Name
The University of New South Wales (UNSW)
Address
High Street, Kensington NSW 2052
Country
Australia
Secondary sponsor category [1] 317545 0
None
Name [1] 317545 0
Address [1] 317545 0
Country [1] 317545 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314382 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 314382 0
Ethics committee country [1] 314382 0
Australia
Date submitted for ethics approval [1] 314382 0
15/12/2022
Approval date [1] 314382 0
17/01/2023
Ethics approval number [1] 314382 0
2022/ETH02223

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131378 0
Prof Ken Butcher
Address 131378 0
Prince of Wales Hospital. 320-346 Barker Street, Randwick NSW 2031
Country 131378 0
Australia
Phone 131378 0
+612 9382 2291
Fax 131378 0
Email 131378 0
kenneth.butcher@health.nsw.gov.au
Contact person for public queries
Name 131379 0
Ken Butcher
Address 131379 0
Prince of Wales Hospital. 320-346 Barker Street, Randwick NSW 2031
Country 131379 0
Australia
Phone 131379 0
+612 9382 2291
Fax 131379 0
Email 131379 0
kenneth.butcher@health.nsw.gov.au
Contact person for scientific queries
Name 131380 0
Ken Butcher
Address 131380 0
Prince of Wales Hospital. 320-346 Barker Street, Randwick NSW 2031
Country 131380 0
Australia
Phone 131380 0
+61 2 9382 2291
Fax 131380 0
Email 131380 0
kenneth.butcher@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.