TICH-3
Research type
Research Study
Full title
Tranexamic acid for Hyperacute Spontaneous Intracerebral Haemorrhage (TICH-3)
IRAS ID
297457
Contact name
Nikola Sprigg
Contact email
Sponsor organisation
University Of Nottingham
Eudract number
2021-001050-62
ISRCTN Number
ISRCTN97695350
Duration of Study in the UK
7 years, 4 months, days
Research summary
ICH is a medical emergency and causes more than 1.7 million strokes worldwide per year3, 4 with a mortality of over 40%.5 More than 10,000 people suffered an ICH last year in England. There is no effective drug treatment for ICH, and only a small proportion of patients benefit from surgery. Haematoma growth is common, occurs early,6, 7 and is the commonest cause of death after ICH. It can potentially be prevented by haemostatic therapies, which are effective in other bleeding conditions.8, 9
Time from symptom onset, baseline haematoma growth and anti-thrombotic therapy use are all independent predictors of haematoma growth.10 The Computed Tomography (CT) spot sign can also improve the prediction model but has not been successful in previous trials11 and is not routinely performed in clinical practice.
ICH related disability causes massive burdens to the affected individual, their family and society. ICH was identified as a priority research area by The Stroke Association, with interventions to stop bleeding as a treatment target.12 The incidence of ICH is increasing due to high blood pressure and the ageing population, with ICH-related death and disability set to rise.13, 14 Recent improvements in stroke pathways have led to rapid imaging, with early diagnosis providing an opportunity to rapidly administer treatments. Implementation of an effective haemostatic therapy such as tranexamic acid (TXA) is therefore possible in ICH.
The proposed study will build on experience from the NIHR HTA funded TICH-2 trial,15 streamline trial methods and enable rapid enrolment of those most likely to benefit. If the haemostatic effect demonstrated in TICH-2 (with reduction in early death) is confirmed in TICH-3, this could change clinical practice globally. By enrolling participants earlier and excluding those with established large HVs, TICH-3 targets patients with the greatest potential to benefit.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
21/EM/0243
Date of REC Opinion
18 Nov 2021
REC opinion
Further Information Favourable Opinion