Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06763055
Registration number
NCT06763055
Ethics application status
Date submitted
17/12/2024
Date registered
8/01/2025
Date last updated
10/04/2025
Titles & IDs
Public title
The Fifth INTEnsive pReventing Secondary Injury in Acute Cerebral Haemorrhage Trial Within ACT-GLOBAL
Query!
Scientific title
The Fifth INTEnsive pReventing Secondary Injury in Acute Cerebral Haemorrhage Trial Within ACT-GLOBAL
Query!
Secondary ID [1]
0
0
ACT-GLOBAL_ICH_01
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
INTERACT5
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Intracerebral Hemorrhage
0
0
Query!
Spontaneous Intracerebral Hemorrhage
0
0
Query!
Supratentorial Intracerebral Haemorrhage
0
0
Query!
Acute Intracerebral Haemorrhage
0
0
Query!
Acute Stroke
0
0
Query!
Condition category
Condition code
Stroke
0
0
0
0
Query!
Haemorrhagic
Query!
Stroke
0
0
0
0
Query!
Ischaemic
Query!
Neurological
0
0
0
0
Query!
Other neurological disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Colchicine 0.5 mg
Treatment: Drugs - Deferoxamine Mesylate
Other interventions - Control (Standard treatment)
Placebo comparator: No deferoxamine mesylate, No colchicine (control) - The group will not receive deferoxamine mesylate or colchicine
Active comparator: Deferoxamine mesylate only - The intervention group will receive deferoxamine mesylate at a dose of 32mg/kg/day via intravenous infusion immediately (within 1 hour) of randomization and continued for 2 consecutive days.
Active comparator: Colchicine only - The intervention group will receive 0.5mg of oral colchicine daily as soon as possible after randomization, to continue for 30 days.
Active comparator: Both deferoxamine mesylate and colchicine - The intervention group will receive deferoxamine mesylate at a dose of 32mg/kg/day via intravenous infusion immediately (within 1 hour) and continued for 2 consecutive days; plus 0.5mg of oral colchicine daily as soon as possible after randomization, to continue for 30 days.
Treatment: Drugs: Colchicine 0.5 mg
The intervention group will receive 0.5mg of oral colchicine daily as soon as possible after randomization, to continue for 30 days.
Treatment: Drugs: Deferoxamine Mesylate
The intervention group will receive deferoxamine mesylate at a dose of 32mg/kg/day via intravenous infusion immediately (within 1 hour) and continued for 2 consecutive days
Other interventions: Control (Standard treatment)
The group will not receive deferoxamine mesylate or colchicine
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Intervention code [2]
0
0
Other interventions
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
mRS scores at 6 months analysed with utility-weights
Query!
Assessment method [1]
0
0
Modified Rankin Scale (mRS) -which scores of 0 to 1 indicate a favorable outcome without or with symptoms but no disability, scores of 2 to 5 indicate increasing levels of disability (and dependency), and a score of 6 indicates death.
Query!
Timepoint [1]
0
0
From enrollment to the 6 month assessment
Query!
Secondary outcome [1]
0
0
Excellent functional neurological outcome (mRS 0-1) at 6 months
Query!
Assessment method [1]
0
0
Modified Rankin Scale (mRS) with scores of 0 to 1 indicating a favorable outcome without or with symptoms but no disability.
Query!
Timepoint [1]
0
0
From enrollment to the 6 month assessment
Query!
Secondary outcome [2]
0
0
Independent functional neurological outcome (mRS 0-2) at 6 months
Query!
Assessment method [2]
0
0
Modified Rankin Scale (mRS) with scores of 2 to 5 indicating increasing levels of disability (and dependency).
Query!
Timepoint [2]
0
0
From enrollment to the 6 month assessment
Query!
Secondary outcome [3]
0
0
Health-related quality of life, as measured by the EQ-5D-5L at month 6
Query!
Assessment method [3]
0
0
The EQ-5D-5L is a generic instrument for describing and valuing health. It is based on a descriptive system that defines health in terms of five dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has five response categories corresponding to: no problems, slight, moderate, severe and extreme problems. The version of the instrument selected for the trial is interviewer administered either in-person, or by telemedicine or by telephone. The respondents will also rate their overall health on the day of the interview on a 0-100 visual analogue scale (EQ-VAS).
Query!
Timepoint [3]
0
0
Completed by telephone at the Day 90 assessment (Day 90 outcomes are assessed in a blinded manner)
Query!
Secondary outcome [4]
0
0
Ordinal shift in the 7 levels of mRS at 6 months
Query!
Assessment method [4]
0
0
Modified Rankin Scale (mRS) in which scores of 0 to 1 indicate a favorable outcome without or with symptoms but no disability, scores of 2 to 5 indicate increasing levels of disability (and dependency), and a score of 6 indicates death.
Query!
Timepoint [4]
0
0
Done at the 6-month assessment (assessed in a blinded manner)
Query!
Secondary outcome [5]
0
0
Disability (mRS 3-5) at 6 months
Query!
Assessment method [5]
0
0
Modified Rankin Scale (mRS) in which scores of 0 to 1 indicate a favorable outcome without or with symptoms but no disability, scores of 2 to 5 indicate increasing levels of disability (and dependency), and a score of 6 indicates death.
Query!
Timepoint [5]
0
0
Done at the 6-month assessment (assessed in a blinded manner)
Query!
Secondary outcome [6]
0
0
NIHSS score at Day 7 and Day 14 (or discharge if earlier)
Query!
Assessment method [6]
0
0
The National Institutes of Health Stroke Scale to measure severity of stroke on scale 0-42.
Query!
Timepoint [6]
0
0
Assessment performed at Day 7 and Day 14 (or discharge if earlier)
Query!
Secondary outcome [7]
0
0
PHE at Day 7 and Day 14 (or discharge if earlier)
Query!
Assessment method [7]
0
0
Perihaematomal oedema (PHE) from CT imaging data assessed at Day 7 and Day 14 (or discharge if earlier)
Query!
Timepoint [7]
0
0
Day 7 and Day 14 (or discharge if earlier)
Query!
Secondary outcome [8]
0
0
Total length of initial hospital stay
Query!
Assessment method [8]
0
0
Total length of initial hospital stay within 6 months after stroke onset
Query!
Timepoint [8]
0
0
Within 6 months after stroke onset
Query!
Secondary outcome [9]
0
0
Ambulatory status at hospital discharge
Query!
Assessment method [9]
0
0
Assessing mobility of the patient at discharge from hospital
Query!
Timepoint [9]
0
0
At the time when patient is discharged from enrolling hospital, within 6 months after stroke onset
Query!
Secondary outcome [10]
0
0
Place of residence at 6 months
Query!
Assessment method [10]
0
0
Assessing the patient's residence at the 6 month follow up. (example: home, rehabilitation, long term care, remains hospitalized)
Query!
Timepoint [10]
0
0
Completed at the 6-month follow-up visit
Query!
Eligibility
Key inclusion criteria
1. Age between 18 and 80 years old
2. Diagnosis of presumed spontaneous supratentorial intracerebral haemorrhage, confirmed by brain imaging
3. Presentation to hospital within 24 hours of symptom onset (or last seen well)
4. Hematoma volume =10 mL or any volume post-surgery
5. NIHSS score >8
6. GCS =8
7. Provide written informed consent by patient (or approved surrogate)
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
80
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
1. Secondary cause of haemorrhage (e.g., structural abnormality such as arteriovenous malformation, cerebral aneurysm, tumour, trauma), or haemorrhagic transformation of acute ischaemic stroke
2. Isolate intraventricular haemorrhage
3. Chronic Kidney Disease
4. Very high likelihood of death within 7 days or poor adherence to study treatment or follow-up
5. Severe comorbid disease that will interfere with outcome assessments (e.g., cancer, chronic airflow disease, heart failure, significant disability)
6. Women who are pregnant or lactating
Exclusion Criteria related to use of deferoxamine:
7. Previous chelation therapy or known hypersensitivity to deferoxamine products;
8. Severe iron deficiency anaemia (haemoglobin <7 g/dL or requiring regular blood transfusions);
9. Taking iron supplements containing >325 mg of ferrous iron;
10. Serum creatinine >2 mg/dL;
11. Patients with known heart failure taking >500 mg of vitamin C
Exclusion criteria related to the use of colchicine:
12. Allergic to colchicine
13. Myelodysplastic hypoplasia, or liver or severe renal failure
14. Use of medication which may interact with colchicine (e.g., strong CYPsA4 inhibitors such as ketoconazole, strong P-glycoprotein inhibitors such as fluconazole)
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people assessing the outcomes
Query!
Query!
Query!
Query!
Intervention assignment
Factorial
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
27/02/2025
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/01/2028
Query!
Actual
Query!
Sample size
Target
2000
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW
Query!
Recruitment hospital [1]
0
0
Royal Prince Alfred Hospital - Sydney
Query!
Recruitment postcode(s) [1]
0
0
2050 - Sydney
Query!
Recruitment outside Australia
Country [1]
0
0
China
Query!
State/province [1]
0
0
Sichuan
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
The George Institute
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Other
Query!
Name [1]
0
0
University of Calgary
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This is a domain within the ACT-GLOBAL platform trial to compare the effectiveness of early and appropriate pharmacological interventions in acute intracerebral hemorrhage (ICH) to control secondary brain injury. Up to 2000 patients with presumed spontaneous supratentorial intracerebral hemorrhage (ICH) will be followed for 6 months (or death, if prior to 6 months). Adaptive interim analyses will be used, with statistical triggers to determine if any of the interventions are superior to control. The end of the trial is defined as the date that all participants have completed their 6-month assessment. A large amount of preclinical data indicates that the outcome from ICH is linked to the detrimental effects of breakdown substances from brain bleeds. However, there remains a lack of compelling evidence supporting the effectiveness of any pharmacological intervention that can mitigate the secondary cerebral injury. The INTERACT domain aims to assess the effectiveness of intravenous deferoxamine and low-dose oral colchicine, both individually and in combination, to standard of care alone, on improving functional outcome in patients with spontaneous supratentorial ICH. Those patients who meet eligibility criteria will be randomized to receive one of four interventions: 1. No deferoxamine mesylate and no colchicine (labeled as control) 2. Deferoxamine mesylate only: deferoxamine mesylate at a dose of 32mg/kg/day via intravenous infusion immediately (within 1 hour) post-randomization and continue for the following 2 consecutive days. 3. Colchicine only: 0.5mg of oral colchicine daily for 30 consecutive days. 4. Both deferoxamine mesylate and colchicine: deferoxamine mesylate at a dose of 32mg/kg/day via intravenous infusion immediately (within 1 hour) post-randomization and continue for the following 2 consecutive days; plus 0.5mg of oral colchicine daily for 30 consecutive days.
Query!
Trial website
https://clinicaltrials.gov/study/NCT06763055
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Xiaoying Chen, PhD BPharm BMgt
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
4039448107
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06763055
Download to PDF