A Phase 4 interventional study of Tranexamic acid injection in Intracerebral Hemorrhagic Stroke, sponsored by Christian Medical College and Hospital, Ludhiana, India. Recruiting at 48 sites in India. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-01-22.
Sponsored by Christian Medical College and Hospital, Ludhiana, India · Phase 4, Interventional, and Treatment
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.
Global Burden of Disease, Injury and Risk factors for hemorrhagic stroke 2010 estimated the burden of spontaneous intracranial haemorrhage (sICH) in India is profound (32 -49%) and it is associated with high mortality (up to 63 %) due to haematoma expansion which occurs in 38% of ICH within first few hours of presentation. Early administration of haemostatic drugs has been used in patients with trauma and was associated with improved outcomes. Similarly, if haemostatic drugs are administered early, which can be a simple and cost-effective intervention, may improve the functional outcomes in patients with sICH. Recently, the Tranexamic acid for hyperacute primary IntraCerebral Haemorrhage (TICH 2 trial), which was done to see the effectiveness of the administration of tranexamic acid on hematoma expansion and functional outcomes at three months in patients who presented with sICH within 8 hours of presentation of symptoms onset, showed a decrease in haematoma expansion but no improvement in functional outcome at 90 days. Further larger randomized control trials are required to ascertain the effect of early administration of Tranexamic acid (TXA) in sICH. In India patients present to hospitals in the early stages that have developed symptoms after sICH and we propose to study the effect of intravenous Tranexamic Acid for hyperacute primary intracerebral haemorrhage within 4.5 hours of sICH.
Trial Population:
This multi-centric study will be conducted at 50 stroke centres in India associated with the INSTRuCT Network. All patients presenting with symptoms of stroke to the hospital and admitted to the stroke units will be screened for eligibility and if met, will be included in the study. The INTRINSIC trial intends to recruit 3400 patients.
Trial Design:
INTRINSIC Trial will be a multicenter, randomized, open-label, clinical trial. The participants will be randomized into two groups in a 1:1 ratio using a central database of INSTRuCT central online randomization. The baseline characteristics will be adjusted to stroke severity using the NIHSS score and the volume of haematoma. The treatment arm will consist of giving intravenously 2 grams of Tranexamic Acid in 100 ml sodium chloride 0.9 % administered over 45 minutes. Control arm patients will receive standard of care management as per the institutional protocol. Both groups will have a repeat CT scan after 24 hours to check for any increase in the haematoma volume. Any deterioration in the Glasgow Coma Scale (GCS) will warrant urgent brain CT scans. Antihypertensive drugs used and their doses to control BP will be recorded for up to 7 days. 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.
The need for this study:
The proportion of ICH is high in India and other LMIC's, particularly in Asia. Currently, there are no effective treatments available for sICH. Moreover, Tranexamic Acid is cheap, easily available and easy to administer.
Adult patients aged more than 18 years, presenting with non- traumatic intracerebral haemorrhage within 4.5 hours of onset of stroke symptoms
Exclusion Criteria:
The treatment arm will consist of giving intravenously 2 grams of Tranexamic Acid in 100 ml sodium chloride 0.9 % administered over 45 minutes. Intensive systolic blood pressure reduction to less than 140 mmHg will be done using antihypertensive agents (intravenous and/or oral) which is to be achieved within one hour and has to be maintained over seven days. BP monitoring is done every 15 minutes in the first hour and thereafter every hour for the next six hours after the initiation of intensive BP control. The choice of antihypertensive will depend on the clinician's preference.
Drug: Tranexamic acid injection
The control arm will receive a standard of care management as per the institutional practice. Intensive systolic blood pressure reduction to less than 140 mmHg will be done using antihypertensive (intravenous and/or oral) which is to be achieved within one hour and has to be maintained over seven days. BP monitoring is done for every 15 minutes in the first hour and thereafter every hour for the next six hours after the initiation of intensive BP control. The choice of antihypertensive will depend on the clinician's preference.
The treatment arm will consist of giving intravenously 2 grams of Tranexamic Acid in 100 ml sodium chloride 0.9 % administered over 45 minutes.
Also known as: Injection Pause 500 mg/5 ml, Injection Cyklokapron 500 mg/5 ml, Injection Trapic 500 mg/5 ml, Injection Tramix 500 mg/5 ml
Death
Death at day 30. Absolute difference of 3% between intervention and control arm for the number of participants that expired at day 30
Time frame: 30 days
Change in hematoma volume
Radiological (CT scan): Change in hematoma volume from baseline to 24 hours scan, hematoma location and new infraction
Time frame: 24 hours
Neurological impairment
Neurological impairment National Institutes of Health Stroke Scale (NIHSS) at day 7 (or discharge if sooner). Lower NIHSS indicates a good outcome.
Time frame: 7 days
modified Rankin Scale (mRS)
Dependency using the seven-level modified Rankin Scale (mRS) at day 90. Good outcome is 0-2 and bad outcome is 3-6. Lower mRS indicated good outcome.
Time frame: 90 days
Quality of life EQ-5D
Quality of life EuroQoL-5 dimension (EQ-5D) at day 90. Lover score indicates good outcome
Time frame: 90 days
Plan to share: No — All information collected from medical records for the study will be stored electronically in a specifically designed database at the Christian Medical College and Hospital, Ludhiana, Punjab, India. Participants information will be identified only by their initials and a study registration number. Any information transferred electronically will be coded to protect confidentiality. All computer records will be password-protected. The study results may be presented at conferences or in scientific publications, but individual participants will not be identifiable. If needed, data will be available in future for other researchers outside the primary research group for secondary purposes, such as meta-analyses, reanalysis, or replication of results.
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Christian Medical College and Hospital, Ludhiana, India