Indian Trial of Tranexamic Acid in Spontaneous Intracerebral Haemorrhage
Recruiting now · Phase 4
Conditions studied: Intracerebral Hemorrhagic Stroke
In brief
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 antihypertensive drug will depend on the clinician's preference. Both groups will have a repeat CT scan after 24 hours to check for any increase in the haematoma volume. Any deterioration in the neurological status will warrant urgent brain imaging. On day 7, the patient will be assessed for their NIHSS score and mRS score. On day 90, quality of life and the functional outcome will be assessed.
Key facts
- Study ID
- NCT05836831
- Run by
- Christian Medical College and Hospital, Ludhiana, India
- People needed
- 3400
- Starts
- 2022-08-30
- Expected to finish
- 2026-11-01
- Last updated by the study team
- 2026-01-22
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adult patients aged more than 18 years, presenting with non- traumatic intracerebral haemorrhage within 4.5 hours of onset of stroke symptoms
You may not qualify if…
- 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.
- 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.
Where it is running
- St Stephen's Hospital — Delhi, India (enrolling)
- Lalitha Super Specialty Hospital — Guntur, Andhra Pradesh, India (enrolling)
- Dr Ramesh Cardiac and Multispecialty Hospital — Guntur, Andhra Pradesh, India (enrolling)
- Assam Medical College — Dibrugarh, Assam, India (enrolling)
- Guwahati Neurological Research Center — Guwahati, Assam, India (enrolling)
- Apollo Excelcare Hospitals — Guwahati, Assam, India (enrolling)
- Baptist Christian Hospital — Tezpur, Assam, India (enrolling)
- Tezpur Medical College and Hospital — Tezpur, Assam, India (enrolling)
- The Calcutta Medical Research Center — Kolkata, West Bengal, India (enrolling)
- Postgraduate Institute for Medical Education and Research — Chandigarh, India (enrolling)
- Government General Hospital — Guntur, Andhra Pradesh, India (enrolling)
- Shree Krishna Hospital Pramukhswami Medical College — Anand, Gujarat, India (enrolling)
- Artemis Hospital — Gurgaon, Haryana, India (enrolling)
- All India Institute of Medical Sciences — Bilāspur, Himachal Pradesh, India (enrolling)
- Atal Institute of Medical Super Specilities, (AIMSS) Chamiana — Shimla, Himachal Pradesh, India (enrolling)
- Sparsh Superspeciality Hospital — Bangalore, Karnataka, India (enrolling)
- KLE's Dr. Prabhakar Kore Hospital & Medical Research Centre — Belagavi, Karnataka, India (enrolling)
- Kasturba Medical College Manipal — Manipal, Karnataka, India (enrolling)
- Baby Memorial Hospital — Calicut, Kerala, India (enrolling)
- ASTER MIMS Hospital — Calicut, Kerala, India (enrolling)
- Amrita Institute for Medical Sciences and Research Center — Kochi, Kerala, India (enrolling)
- Government Medical College Trivandrum — Thiruvananthapuram, Kerala, India (enrolling)
- Sree Chitra Tirunal Institute for Medical Sciences and Technology — Thiruvananthapuram, Kerala, India (enrolling)
- Fortis Hospital Mulund — Mumbai, Maharashtra, India (enrolling)
- Holy Spirit Hospital — Mumbai, Maharashtra, India (enrolling)
Full record on ClinicalTrials.gov
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