To assess whether early administration of TXA improves outcome in patients with ICH.
Primary Outcome
Secondary Outcome
1) Change in hematoma volume from baseline to 24 h.
2) Neurological impairment (NIHSS) at day 7.
3) Modified Rankin Scale (mRS) and Quality of life (EQ-5DL) at day 90
GBD 2019 reported a high burden of stroke including ICH in LMICs such as India, constituing 11-35% of all strokes with a high mortality. Raised ICP due to hematoma expansion occurings within first few hours is the cause of mortality. Early adminstarion of TXA has been proven to be an effective startegy in TBI patients and in some trials of non traumatic ICH have been promising.
Trial design - Multi centred, pragmatic, open label trial. Participants will be randomised into two groups using an online centralised web database. Inclusion criteria- Adults more than18 years who present with ICH within 4.5 hours of first symptom onset will be included in the study. Intervention- Study participants will receive 2 grams of TXA administered within 45 minutes and Control participants will receive standard of care. Intensive BP reduction as per INTERACT 2 protocol will be done in both groups. Follow up - CT Head will be done at 0, 24 hours to assess the haematoma size.
Sample Size- According to TICH-2, fewer deaths were observed in the TXA versus placebo group [101(9%) vs 123(11%)] with binary OR of 0.73 [0.95 CI (0.53-0.99)] (p=0.04), the sample size calculated was found to be 1800 in each group (for power of 80% and alpha error of 5%). 50 centres in India have been included to recruit patients in an estimated time period of 4 years.
If TXA is found to be beneficial, it will have a huge impact on the management of ICH especially in LMICs