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New treatment option for Intracerebral Hemorrhage
Official title The Fifth INTEnsive pReventing Secondary Injury in Acute Cerebral Haemorrhage Trial Within ACT-GLOBAL
ClinicalTrials.gov ID: NCT06763055
What this study is testing
What is Colchicine 0.5 mg?
Colchicine 0.5 mg is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for intracerebral hemorrhage.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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
You likely can't join if
- Secondary cause of haemorrhage (e.g., structural abnormality such as arteriovenous malformation, cerebral aneurysm, tumour, trauma), or haemorrhagic...
- 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 Exclusion Criteria related to use of deferoxamine:
See the full eligibility criteria
- 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)
- 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 Exclusion Criteria related to use of deferoxamine:
- 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 Exclusion criteria related to the use of colchicine:
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Sydney, New South Wales, Australia
- Chengdu, Sichuan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sydney, New South Wales, Australia; Chengdu, Sichuan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.