For the latest trial, people who were diagnosed with bleeding on the brain, confirmed by CT scan, were offered the chance to take part in the study. When the person was too ill to decide, permission was asked of their family or close friends. When no family members were available, a doctor unconnected with the study decided whether the patient should take part.
The five-year TICH-2 trial recruited more than 2,000 patients from 124 hospitals in 12 countries between 2013 and 2017. They were randomly sorted into two patient groups. One received tranexamic acid within eight hours of stroke, and the other was given a saline placebo. In the UK, more than 80 hospitals took part in the study with support from the NIHR clinical research network.
CT scans of the patients’ brains were performed at 24 hours after their stroke, and patients’ progress was monitored and measured at day two and day seven after their stroke. The final follow-up was performed at 90 days.
Tranexamic acid did not improve the outcome for patients after 90 days; there was no significant difference in the number of patients who had subsequently died or had been left with disabilities between the tranexamic acid and placebo groups at three months.
In the tranexamic acid group, however, there were fewer deaths by day seven following the stroke. At day two, fewer people on tranexamic acid experienced a worsening of the bleed on their brain, and they had smaller amounts of blood in the brain, compared with their control group counterparts. Also, the number of patients who had associated serious complications such as pneumonia and brain swelling was lower in the group that had received tranexamic acid treatment, compared with controls.
The trial also found evidence that tranexamic acid might be more effective in patients with lower blood pressure. Participants with blood pressure lower than 170 mm Hg had a more favorable outcome than those with blood pressure of 170 mm Hg and above. Other studies have confirmed that the sooner tranexamic acid is given, the more effective it is. The ideal is to administer the drug within three hours of bleeding onset, according to the researchers. In this study, one-third of patients were given treatment within three hours of stroke onset.
As a result, the researchers have highlighted the need for further studies to find out whether giving an earlier dose of tranexamic acid might be beneficial for patients.