METHODS: This is a prospective observational cohort study conducted in Sarawak General Hospital, Malaysia. Patients 12 years of age and older with mild to severe TBI who had a brain computed tomography (CT) done within eight hours of injury were enrolled in the study. A total of 334 patients were recruited from the 5th of August 2016 until the 8th of March 2018 in Sarawak General Hospital. In all 167 of them were administered with TXA and another 167 of the patients were not. The primary outcome expected is the number of good outcomes in isolated TBI patients given TXA. Good outcome is defined by Glasgow Outcome Score-Extended (GOSE) of five and above. Secondary outcome was clot expansion of an intracranial bleed seen on the first scan that had expanded by 25% or more on any dimension on the second scan.
RESULTS: The TXA did not show significant trend of good outcome in terms of GOSE (p=0.763). However, for moderate and severe acute subdural haemorrhage (SDH) subgroups, there was a significant difference (p=0.042). Clot expansion was present in 14 patients (12.7%) with TXA given and in 54 patients (38.8%) without TXA. The difference was statistically significant (p<0.001). Of the patients who received TXA, there was one case (0.6%) of deep vein thrombosis. Apart from that, TXA showed non-significant trend in reducing mortality (p=0.474).
CONCLUSIONS: Tranexamic acid reduces the rate of clot expansion in TBI by 26.1% (38.8-12.7%) without significantly increasing the risk of a thrombotic event. It can also improve the outcome of moderate and severe TBI patients with acute SDH.