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New treatment option for Intracerebral Hemorrhagic Stroke
Official title Indian Trial of Tranexamic Acid in Spontaneous Intracerebral Haemorrhage
ClinicalTrials.gov ID: NCT05836831
What this study is testing
What is Tranexamic acid injection?
Tranexamic acid injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for intracerebral hemorrhagic stroke.
Also referred to as Injection Pause 500 mg/5 ml, Injection Cyklokapron 500 mg/5 ml.
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 multicenter, pragmatic randomized, open-label clinical trial aims to assess whether Tranexamic Acid improves outcomes in adult patients with spontaneous intracerebral haemorrhage. The participants presenting within 4.5 hours of the onset of symptoms of stroke with intracerebral haemorrhage confirmed on Computed Tomography (CT Scan) will be randomized into two groups in a 1:1 ratio using a central online randomization.
- Phase 4: studies an already-approved treatment
- 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 99
You may be able to join if
- Adult patients aged more than 18 years, presenting with non- traumatic intracerebral haemorrhage within 4.5 hours of onset of stroke symptoms
You likely can't join if
- Patients with ICH secondary to anticoagulation, thrombolysis, or known underlying structural abnormality such as arteriovenous malformation...
- Contraindication to TXA.
- Concurrent participation in another trial.
- Pre-stroke life expectancy \<3 months (e.g. advanced metastatic cancer).
- Glasgow coma scale (GCS) ⩽5.
- ICH secondary to trauma.
See the full eligibility criteria
- Adult patients aged more than 18 years, presenting with non- traumatic intracerebral haemorrhage within 4.5 hours of onset of stroke symptoms
- Patients with ICH secondary to anticoagulation, thrombolysis, or known underlying structural abnormality such as arteriovenous malformation, aneurysm, tumor, venous thrombosis or due to known hereditary coagulation...
- Contraindication to TXA.
- Concurrent participation in another trial.
- Pre-stroke life expectancy \<3 months (e.g. advanced metastatic cancer).
- Glasgow coma scale (GCS) ⩽5.
- ICH secondary to trauma.
- Women of childbearing potential, pregnant, or breastfeeding at randomization.
- Geographical or other factors that prohibit follow-upto 90 days.
- Concurrent or planned treatment with any other hemostatic agents.
- ICH volume \>60 mL as measured by ABC/2 method.
The study team makes the final eligibility decision.
Where it's taking place
- Guntur, Andhra Pradesh, India
- Dibrugarh, Assam, India
- Guwahati, Assam, India
- Tezpur, Assam, India
- Panjim, Goa, India
- Anand, Gujarat, India
- Gurgaon, Haryana, India
- Bilāspur, Himachal Pradesh, India
- Shimla, Himachal Pradesh, India
- Bangalore, Karnataka, India
- Belagavi, Karnataka, India
- Manipal, Karnataka, India
- Calicut, Kerala, India
- Kochi, Kerala, India
- Thiruvananthapuram, Kerala, India
- Mumbai, Maharashtra, India
- Pune, Maharashtra, India
- New Delhi, National Capital Territory of Delhi, India
- Bhubaneswar, Odisha, India
- Farīdkot, Punjab, India
+ 14 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guntur, Andhra Pradesh, India; Dibrugarh, Assam, India; Guwahati, Assam, India; Tezpur, Assam, India; Panjim, Goa, India; Anand, Gujarat, India and 28 more location(s). 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.