Condition: Intracerebral Hemorrhagic Stroke · Sponsor: Christian Medical College and Hospital, Ludhiana, India
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.
This description comes directly from the study's public registry record.
Jeyaraj D Pandian, MD DM · 9915784750 · jeyarajpandian@hotmail.com
Atul Phillips, MD FNB · 9999464983 · atulphillips@yahoo.co.in
Always discuss trial participation with your own doctor first.
| Government General Hospital | Guntur, Andhra Pradesh, India | Recruiting |
| Lalitha Super Specialty Hospital | Guntur, Andhra Pradesh, India | Recruiting |
| Dr Ramesh Cardiac and Multispecialty Hospital | Guntur, Andhra Pradesh, India | Recruiting |
| Assam Medical College | Dibrugarh, Assam, India | Recruiting |
| Guwahati Neurological Research Center | Guwahati, Assam, India | Recruiting |
| Apollo Excelcare Hospitals | Guwahati, Assam, India | Recruiting |
| Baptist Christian Hospital | Tezpur, Assam, India | Recruiting |
| Tezpur Medical College and Hospital | Tezpur, Assam, India | Recruiting |
| Manipal Hospital | Panjim, Goa, India | Not Yet Recruiting |
| Shree Krishna Hospital Pramukhswami Medical College | Anand, Gujarat, India | Recruiting |
| Artemis Hospital | Gurgaon, Haryana, India | Recruiting |
| All India Institute of Medical Sciences | Bilāspur, Himachal Pradesh, India | Recruiting |
+ 36 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05836831