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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
8/01/2025

Titles & IDs
Public title
The Fifth INTEnsive pReventing Secondary Injury in Acute Cerebral Haemorrhage Trial Within ACT-GLOBAL
Scientific title
The Fifth INTEnsive pReventing Secondary Injury in Acute Cerebral Haemorrhage Trial Within ACT-GLOBAL
Secondary ID [1] 0 0
ACT-GLOBAL_ICH_01
Universal Trial Number (UTN)
Trial acronym
INTERACT5
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intracerebral Hemorrhage 0 0
Spontaneous Intracerebral Hemorrhage 0 0
Supratentorial Intracerebral Haemorrhage 0 0
Acute Intracerebral Haemorrhage 0 0
Acute Stroke 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
mRS scores at 6 months analysed with utility-weights
Timepoint [1] 0 0
From enrollment to the 6 month assessment
Secondary outcome [1] 0 0
Excellent functional neurological outcome (mRS 0-1) at 6 months
Timepoint [1] 0 0
From enrollment to the 6 month assessment
Secondary outcome [2] 0 0
Independent functional neurological outcome (mRS 0-2) at 6 months
Timepoint [2] 0 0
From enrollment to the 6 month assessment
Secondary outcome [3] 0 0
Health-related quality of life, as measured by the EQ-5D-5L at month 6
Timepoint [3] 0 0
Completed by telephone at the Day 90 assessment (Day 90 outcomes are assessed in a blinded manner)
Secondary outcome [4] 0 0
Ordinal shift in the 7 levels of mRS at 6 months
Timepoint [4] 0 0
Done at the 6-month assessment (assessed in a blinded manner)
Secondary outcome [5] 0 0
Disability (mRS 3-5) at 6 months
Timepoint [5] 0 0
Done at the 6-month assessment (assessed in a blinded manner)
Secondary outcome [6] 0 0
NIHSS score at Day 7 and Day 14 (or discharge if earlier)
Timepoint [6] 0 0
Assessment performed at Day 7 and Day 14 (or discharge if earlier)
Secondary outcome [7] 0 0
PHE at Day 7 and Day 14 (or discharge if earlier)
Timepoint [7] 0 0
Day 7 and Day 14 (or discharge if earlier)
Secondary outcome [8] 0 0
Total length of initial hospital stay
Timepoint [8] 0 0
Within 6 months after stroke onset
Secondary outcome [9] 0 0
Ambulatory status at hospital discharge
Timepoint [9] 0 0
At the time when patient is discharged from enrolling hospital, within 6 months after stroke onset
Secondary outcome [10] 0 0
Place of residence at 6 months
Timepoint [10] 0 0
Completed at the 6-month follow-up visit

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)
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Factorial
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/01/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2029
Actual
Sample size
Target
2000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2050 - Sydney
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Sichuan

Funding & Sponsors
Primary sponsor type
Other
Name
The George Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Calgary
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT06763055
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Xiaoying Chen, PhD BPharm BMgt
Address 0 0
Country 0 0
Phone 0 0
4039448107
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06763055