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Indian Trial of Tranexamic Acid in Spontaneous Intracerebral Haemorrhage

RecruitingPhase 4Ages 18 Years - 99 YearsAllChristian Medical College and Hospital, Ludhiana,…
NCT05836831 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. The treatment arm will consist of giving intravenously 2 grams of Tranexamic Acid in 100 ml 0.9% sodium chloride administered over 45 minutes. Control arm patients will receive standard of care treatment as per the institutional protocol. In both arms, intensive systolic blood pressure reduction to less than 140 mmHg will be done using antihypertensive medications, which has to be achieved within one hour and will be maintained over next seven days. The choice of anti

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📋 Eligibility rules (as published)
Inclusion Criteria: Adult patients aged more than 18 years, presenting with non- traumatic intracerebral haemorrhage within 4.5 hours of onset of stroke symptoms Exclusion Criteria: 1. 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 disorders. 2. Contraindication to TXA. 3. Concurrent participation in another trial. 4. Pre-stroke life expectancy \<3 months (e.g. advanced metastatic cancer). 5. Glasgow coma scale (GCS) ⩽5. 6. ICH secondary to trauma. 7. Women of childbearing potential, pregnant, or breastfeeding at randomization. 8. Geographical or other factors that prohibit follow-upto 90 days. 9. Concurrent or planned treatment with any other hemostatic agents. 10. ICH volume \>60 mL as measured by ABC/2 method.
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What it tests

  • Tranexamic acid injection
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Where

48 sites
Government General Hospital
Guntur, India
Lalitha Super Specialty Hospital
Guntur, India
Dr Ramesh Cardiac and Multispecialty Hospital
Guntur, India
Assam Medical College
Dibrugarh, India
Guwahati Neurological Research Center
Guwahati, India
Apollo Excelcare Hospitals
Guwahati, India
Baptist Christian Hospital
Tezpur, India
Tezpur Medical College and Hospital
Tezpur, India

…and 40 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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