Intracerebral HemorrhagePhase 3INTERACT5NCT06763055
The Fifth INTEnsive pReventing Secondary Injury in Acute Cerebral Haemorrhage Trial Within ACT-GLOBAL
A Phase 3 study testing Colchicine 0.5 mg and Deferoxamine Mesylate in people with Intracerebral Hemorrhage and Spontaneous Intracerebral Hemorrhage, run by The George Institute at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracerebral Hemorrhage, Spontaneous Intracerebral Hemorrhage, Supratentorial Intracerebral Haemorrhage
- What is being tested?
- Colchicine 0.5 mg and Deferoxamine Mesylate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,000 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 27 Feb 2025to Jan 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 80 years old
- Diagnosis of presumed spontaneous supratentorial intracerebral haemorrhage, confirmed by brain imaging
- Presentation to hospital within 24 hours of symptom onset (or last seen well)
- Hematoma volume ≥10 mL or any volume post-surgery
- NIHSS score >8
- GCS ≥8
- Provide written informed consent by patient (or approved surrogate)
Who cannot join
- Secondary cause of haemorrhage (e.g., structural abnormality such as arteriovenous malformation, cerebral aneurysm, tumour, trauma), or haemorrhagic transformation of acute ischaemic stroke
- Isolate intraventricular haemorrhage
- Chronic Kidney Disease
- Very high likelihood of death within 7 days or poor adherence to study treatment or follow-up
- Severe comorbid disease that will interfere with outcome assessments (e.g., cancer, chronic airflow disease, heart failure, significant disability)
- Women who are pregnant or lactating
Show all 14Show fewer
- Previous chelation therapy or known hypersensitivity to deferoxamine products;
- Severe iron deficiency anaemia (haemoglobin <7 g/dL or requiring regular blood transfusions);
- Taking iron supplements containing >325 mg of ferrous iron;
- Serum creatinine >2 mg/dL;
- Patients with known heart failure taking >500 mg of vitamin C
- Allergic to colchicine
- Myelodysplastic hypoplasia, or liver or severe renal failure
- Use of medication which may interact with colchicine (e.g., strong CYPsA4 inhibitors such as ketoconazole, strong P-glycoprotein inhibitors such as fluconazole)
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Australia1 site, 1 recruiting
- Not yet recruiting
Royal Prince Alfred Hospital
Sydney, New South Wales, 2050
Xiaoying Chen, PhD BPharm BMgt, 4039448107, xchen@georgeinstitute.org.au
Timothy Ang, MD
China1 site, 1 recruiting
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Xiaoying Chen, 4039448107, xchen@georgeinstitute.org.au
About this study
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.
Read more
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:
- No deferoxamine mesylate and no colchicine (labeled as control)
- 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.
- Colchicine only: 0.5mg of oral colchicine daily for 30 consecutive days.
- 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.
Read the detailed description
Intracerebral hemorrhage (ICH) is a severe type of stroke, responsible for substantial disability and death worldwide. It accounts for 6.5% to 19.6% of all strokes, with incidence rates increasing, especially in low- and middle-income countries. Survivors often face significant consequences, including functional impairments, recurrent strokes, cognitive decline, and depression.
Despite advancements in acute stroke care, there are few effective treatments specifically targeting the brain damage caused by ICH. Previous research has identified that the formation of perihaematomal oedema (PHE) is a critical factor in poor recovery, making it a key focus for therapeutic development.
INTERACT5 domain will focus on two promising medications. Deferoxamine, an iron-chelating agent, targets oxidative stress caused by iron released from damaged brain tissue. Studies suggest it may reduce brain swelling and secondary injury after ICH. Colchicine, an anti-inflammatory medication, inhibits pathways involved in inflammation, which may help minimize brain damage. INTERACT5 will enroll patients aged 18-80 with acute spontaneous supratentorial ICH, confirmed through imaging, who present to the hospital within 24 hours of symptom onset. Other domain-specific inclusion criteria:
- Hematoma volume ≥≥10 mL or any volume post-surgery
- NIHSS score >8
- GCS ≥8>7
Participants will be randomized to one of four groups: standard care, deferoxamine alone, colchicine alone, or both treatments combined. Deferoxamine will be administered intravenously (32 mg/kg/day within 1 hour and continued for 2 consecutive days), and colchicine will be given orally (0.5 mg daily for 30 days).
The study's primary outcome is the improvements in functional outcomes at 6 months, measured by the modified Rankin Scale (mRS). Secondary outcomes include EQ-5D-5L at 6 months, changes in PHE size, NIHSS scores, length of hospital stay, ambulatory status at discharge and safety indicators such as mortality at 6 months/SAEs to 6 month, kidney and liver function.
Response Adaptive Randomization (RAR) will be used in this domain to allow readjustment of recruitment towards treatment arms with more favorable emerging effects. Randomization will use minimization method to minimize the imbalance between the number of patients in each treatment group over a number of factors including region, location (deep vs cortical)age (>65 vs ≤65 years old), sex (male vs female), time from onset (>6 vs ≤6 hours), haematoma volume (10-29 vs ≥30 mL), receipt of any decompressive surgery (yes vs no), and intraventricular extension of ICH, etc.
- Conditions
- Intracerebral Hemorrhage, Spontaneous Intracerebral Hemorrhage, Supratentorial Intracerebral Haemorrhage, Acute Intracerebral Haemorrhage, Acute Stroke
- Being tested
- Colchicine 0.5 mg, Deferoxamine Mesylate, Control (Standard treatment)
- Keywords
- Stroke, Acute Stroke, ICH, Intracerebral Hemorrhage, Platform Trial, Adaptive Platform Trial, Supratentorial ICH, secondary brain injury, deferoxamine mesylate, colchicine
- Medical subject headings
- Cerebral Hemorrhage, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colchicine 0.5 mgDrug
The intervention group will receive 0.5mg of oral colchicine daily as soon as possible after randomization, to continue for 30 days.
Deferoxamine MesylateDrug
Also called Yes DX
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
Control (Standard treatment)Other
The group will not receive deferoxamine mesylate or colchicine
| Study group | Role | What they receive |
|---|---|---|
| No deferoxamine mesylate, No colchicine (control) | Placebo comparator | The group will not receive deferoxamine mesylate or colchicine Receives: Other: Control (Standard treatment) |
| Deferoxamine mesylate only | Active comparator | 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. Receives: Drug: Deferoxamine Mesylate |
| Colchicine only | Active comparator | The intervention group will receive 0.5mg of oral colchicine daily as soon as possible after randomization, to continue for 30 days. Receives: Drug: Colchicine 0.5 mg |
| Both deferoxamine mesylate and colchicine | Active comparator | 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. Receives: Drug: Colchicine 0.5 mg; Drug: Deferoxamine Mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
mRS scores at 6 months analysed with utility-weights
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.
Measured: From enrollment to the 6 month assessment
Secondary outcomes (10)
Excellent functional neurological outcome (mRS 0-1) at 6 months
Modified Rankin Scale (mRS) with scores of 0 to 1 indicating a favorable outcome without or with symptoms but no disability.
Measured: From enrollment to the 6 month assessment
Independent functional neurological outcome (mRS 0-2) at 6 months
Modified Rankin Scale (mRS) with scores of 2 to 5 indicating increasing levels of disability (and dependency).
Measured: From enrollment to the 6 month assessment
Health-related quality of life, as measured by the EQ-5D-5L at month 6
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).
Measured: Completed by telephone at the Day 90 assessment (Day 90 outcomes are assessed in a blinded manner)
Ordinal shift in the 7 levels of mRS at 6 months
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.
Measured: Done at the 6-month assessment (assessed in a blinded manner)
Disability (mRS 3-5) at 6 months
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.
Measured: Done at the 6-month assessment (assessed in a blinded manner)
NIHSS score at Day 7 and Day 14 (or discharge if earlier)
The National Institutes of Health Stroke Scale to measure severity of stroke on scale 0-42.
Measured: Assessment performed at Day 7 and Day 14 (or discharge if earlier)
PHE at Day 7 and Day 14 (or discharge if earlier)
Perihaematomal oedema (PHE) from CT imaging data assessed at Day 7 and Day 14 (or discharge if earlier)
Measured: Day 7 and Day 14 (or discharge if earlier)
Total length of initial hospital stay
Total length of initial hospital stay within 6 months after stroke onset
Measured: Within 6 months after stroke onset
Ambulatory status at hospital discharge
Assessing mobility of the patient at discharge from hospital
Measured: At the time when patient is discharged from enrolling hospital, within 6 months after stroke onset
Place of residence at 6 months
Assessing the patient's residence at the 6 month follow up. (example: home, rehabilitation, long term care, remains hospitalized)
Measured: Completed at the 6-month follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start27 Feb 2025
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- The INTERACT5 Domain includes two treatments provided in a factorial manner, creating four different treatment arms. The two treatments are: A. Intravenous deferoxamine mesylate (abbreviated as DX) B. Low-dose oral colchicine (abbreviated as OC) The four arms including three interventions and one control in the domain are the 2x2 factorial of each treatment/no treatment. The one control arm and three intervention arms in the domain are: 1. No DX and No OC (labeled as Control) 2. Yes DX and No OC 3. No DX and Yes OC 4. Yes DX and Yes OC
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The George Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Calgary
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06763055
- Sponsor's protocol ID
- ACT-GLOBAL_ICH_01
- Acronym
- INTERACT5
- Status last verified
- Jul 2026
- First submitted
- 17 Dec 2024
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Domain information and tabular trial results will be posted on the National Institutes of Health's website www.clinicaltrials.gov within one year of domain completion.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Fifth INTEnsive pReventing Secondary Injury in Acute Cerebral Haemorrhage Trial Within ACT-GLOBAL
- ClinicalTrials.gov ID
- NCT06763055
- Acronym / sponsor ID
- INTERACT5 / ACT-GLOBAL_ICH_01
- Conditions
- Intracerebral Hemorrhage, Spontaneous Intracerebral Hemorrhage, Supratentorial Intracerebral Haemorrhage, Acute Intracerebral Haemorrhage, Acute Stroke
- Keywords
- Stroke, Acute Stroke, ICH, Intracerebral Hemorrhage, Platform Trial, Adaptive Platform Trial, Supratentorial ICH, secondary brain injury
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- The George InstituteUniversity, hospital or other
- Collaborators
- University of Calgary
- Study start
- 27 Feb 2025 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 8 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- No deferoxamine mesylate and no colchicine (labeled as control)
- 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.
- Colchicine only: 0.5mg of oral colchicine daily for 30 consecutive days.
- 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.
Detailed description
Intracerebral hemorrhage (ICH) is a severe type of stroke, responsible for substantial disability and death worldwide. It accounts for 6.5% to 19.6% of all strokes, with incidence rates increasing, especially in low- and middle-income countries. Survivors often face significant consequences, including functional impairments, recurrent strokes, cognitive decline, and depression.
Despite advancements in acute stroke care, there are few effective treatments specifically targeting the brain damage caused by ICH. Previous research has identified that the formation of perihaematomal oedema (PHE) is a critical factor in poor recovery, making it a key focus for therapeutic development.
INTERACT5 domain will focus on two promising medications. Deferoxamine, an iron-chelating agent, targets oxidative stress caused by iron released from damaged brain tissue. Studies suggest it may reduce brain swelling and secondary injury after ICH. Colchicine, an anti-inflammatory medication, inhibits pathways involved in inflammation, which may help minimize brain damage. INTERACT5 will enroll patients aged 18-80 with acute spontaneous supratentorial ICH, confirmed through imaging, who present to the hospital within 24 hours of symptom onset. Other domain-specific inclusion criteria:
- Hematoma volume ≥≥10 mL or any volume post-surgery
- NIHSS score >8
- GCS ≥8>7
Participants will be randomized to one of four groups: standard care, deferoxamine alone, colchicine alone, or both treatments combined. Deferoxamine will be administered intravenously (32 mg/kg/day within 1 hour and continued for 2 consecutive days), and colchicine will be given orally (0.5 mg daily for 30 days).
The study's primary outcome is the improvements in functional outcomes at 6 months, measured by the modified Rankin Scale (mRS). Secondary outcomes include EQ-5D-5L at 6 months, changes in PHE size, NIHSS scores, length of hospital stay, ambulatory status at discharge and safety indicators such as mortality at 6 months/SAEs to 6 month, kidney and liver function.
Response Adaptive Randomization (RAR) will be used in this domain to allow readjustment of recruitment towards treatment arms with more favorable emerging effects. Randomization will use minimization method to minimize the imbalance between the number of patients in each treatment group over a number of factors including region, location (deep vs cortical)age (>65 vs ≤65 years old), sex (male vs female), time from onset (>6 vs ≤6 hours), haematoma volume (10-29 vs ≥30 mL), receipt of any decompressive surgery (yes vs no), and intraventricular extension of ICH, etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- The INTERACT5 Domain includes two treatments provided in a factorial manner, creating four different treatment arms. The two treatments are: A. Intravenous deferoxamine mesylate (abbreviated as DX) B. Low-dose oral colchicine (abbreviated as OC) The four arms including three interventions and one control in the domain are the 2x2 factorial of each treatment/no treatment. The one control arm and three intervention arms in the domain are: 1. No DX and No OC (labeled as Control) 2. Yes DX and No OC 3. No DX and Yes OC 4. Yes DX and Yes OC
| Arm | Type | Receives |
|---|---|---|
| No deferoxamine mesylate, No colchicine (control) | Placebo comparator | Other: Control (Standard treatment)The group will not receive deferoxamine mesylate or colchicine |
| Deferoxamine mesylate only | Active comparator | Drug: Deferoxamine MesylateThe 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. |
| Colchicine only | Active comparator | Drug: Colchicine 0.5 mgThe intervention group will receive 0.5mg of oral colchicine daily as soon as possible after randomization, to continue for 30 days. |
| Both deferoxamine mesylate and colchicine | Active comparator | Drug: Colchicine 0.5 mg, Drug: Deferoxamine MesylateThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age between 18 and 80 years old
- Diagnosis of presumed spontaneous supratentorial intracerebral haemorrhage, confirmed by brain imaging
- Presentation to hospital within 24 hours of symptom onset (or last seen well)
- Hematoma volume ≥10 mL or any volume post-surgery
- NIHSS score >8
Key exclusion criteria (14 listed)
- Secondary cause of haemorrhage (e.g., structural abnormality such as arteriovenous malformation, cerebral aneurysm, tumour, trauma), or haemorrhagic transformation of acute ischaemic stroke
- Isolate intraventricular haemorrhage
- Chronic Kidney Disease
- Very high likelihood of death within 7 days or poor adherence to study treatment or follow-up
- Severe comorbid disease that will interfere with outcome assessments (e.g., cancer, chronic airflow disease, heart failure, significant disability)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colchicine 0.5 mgThe intervention group will receive 0.5mg of oral colchicine daily as soon as possible after randomization, to continue for 30 days. | Drug | Both deferoxamine mesylate and colchicine, Colchicine only |
| Deferoxamine MesylateAlso: Yes DXThe 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 | Drug | Both deferoxamine mesylate and colchicine, Deferoxamine mesylate only |
| Control (Standard treatment)The group will not receive deferoxamine mesylate or colchicine | Other | No deferoxamine mesylate, No colchicine (control) |
Primary outcome
mRS scores at 6 months analysed with utility-weights
Time frame: From enrollment to the 6 month assessment
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.
10 secondary outcomes
Excellent functional neurological outcome (mRS 0-1) at 6 months
Time frame: From enrollment to the 6 month assessment
Independent functional neurological outcome (mRS 0-2) at 6 months
Time frame: From enrollment to the 6 month assessment
Health-related quality of life, as measured by the EQ-5D-5L at month 6
Time frame: Completed by telephone at the Day 90 assessment (Day 90 outcomes are assessed in a blinded manner)
Ordinal shift in the 7 levels of mRS at 6 months
Time frame: Done at the 6-month assessment (assessed in a blinded manner)
Disability (mRS 3-5) at 6 months
Time frame: Done at the 6-month assessment (assessed in a blinded manner)
NIHSS score at Day 7 and Day 14 (or discharge if earlier)
Time frame: Assessment performed at Day 7 and Day 14 (or discharge if earlier)
PHE at Day 7 and Day 14 (or discharge if earlier)
Time frame: Day 7 and Day 14 (or discharge if earlier)
Total length of initial hospital stay
Time frame: Within 6 months after stroke onset
Ambulatory status at hospital discharge
Time frame: At the time when patient is discharged from enrolling hospital, within 6 months after stroke onset
Place of residence at 6 months
Time frame: Completed at the 6-month follow-up visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- ACT-GLOBAL Master Protocol Registration LinkLink provided by the sponsor.
- Individual participant dataSharing planned: No. Domain information and tabular trial results will be posted on the National Institutes of Health's website www.clinicaltrials.gov within one year of domain completion.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Colchicine 0.5 mg and Deferoxamine Mesylate in people with Intracerebral Hemorrhage and Spontaneous Intracerebral Hemorrhage, run by The George Institute at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoying Chen, PhD BPharm BMgt (4039448107, xchen@georgeinstitute.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mRS scores at 6 months analysed with utility-weights (time frame: From enrollment to the 6 month assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.