TICH-2: Tranexamic acid for hyperacute primary IntraCerebral Haemorrhage
Abgeschlossen · 2016 bis 2018
Kägi Georg, Kapauer Monika, Vehoff Jochen, Müller Anna
Despite development of effective treatments for ischaemic stroke (thrombolysis, aspirin, hemicraniectomy) there is no proven effective treatment for spontaneous intracerebral haemorrhage (SICH).
Trials conducted with treatments such as intesive blood pressure treatment, surgery and haemostatic therapy did not Show an improvement of the outcome.
In a randomised controlled trial in traumatic intracerebral haemorrhage, tranexamic acid reduced death, OR 0.69 (0.35 -1.39), and death or dependency, 0.76 (0.46 –1.27), without increased thromboembolic Events. Tranexamic acid has been tested in aneurismal subarachnoid haemorrhage, where it reduced the risk of re-bleeding at the expense of increased risk of cerebral ischaemia. However administration was for a week, conferring prolonged exposure to risk of ischaemic events. Additionally, tranexamic acid has been found to restrict haematoma expansion in acute SICH in a small non randomised study, although this did not report on safety. In another small study (n=156), rapid administration of a bolus of tranexamic acid within 24 hours of stroke was observed to reduce haematoma expansion (17.5% vs. 4.3%). In this study, tranexamic acid was given in combination with intensive blood pressure control, suggesting that it may be possible to combine haemostatic and haemodynamic approaches.
There have been recent calls in the literature for large clinical trials to examine the use of tranexamic acid in SICH.
The purpose of this study is to assess whether tranexamic acid is safe and reduces death and dependency after hyperacute (within 8 hours of onset) spontaneous intracerebral haemorrhage.