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TICH-2 trial - Tranexamic acid for IntraCerebral Haemorrhage 2

  • The trial opened in March 2013 and recruitment ended with 2,325 participants in September 2017, with further follow-up for one year.
  • The protocol paper (PDF) was published online in the International Journal of Stroke in April 2016.
  • The trial was funded by the NIHR HTA and the University of Nottingham acted as the trial sponsor.
For further information please contact us.
Trial manager: Diane Havard
Chief investigator: Professor Nikola Sprigg
Nottingham stroke trials office:

    Telephone: +44 (0)115 823 1770     Fax: +44 (0)115 823 1771

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Title Tranexamic acid for hyperacute primary IntraCerebral Haemorrhage (TICH-2)
Acronym TICH-2
Short title Tranexamic acid for intracerebral haemorrhage (TICH-2)
Chief investigator Professor Nikola Sprigg
Objectives To assess whether tranexamic acid is safe and reduces death and dependency after hyperacute (within 8 hours of onset) spontaneous intracerebral haemorrhage.
Trial configuration A phase III prospective pragmatic double blind randomised placebo controlled trial
Setting Secondary care
Sample size estimate With alpha=0.05, power=90%, assuming losses to follow up=5% and covariate adjustment reduces sample size by 20%, 2,000 participants will need to be recruited to detect a treatment effect of OR 0.74 by shift analysis of mRS outcome
Number of participants 2,000
Eligibility criteria Inclusions
  • Adult patient with primary (spontaneous) intracerebral haemorrhage confirmed on CT scan of brain
  • Event less than 8 hours after onset (for sleep stroke, take onset as bed time)
  • Patients with intracerebral haemorrhage secondary to anticoagulation, thrombolysis or an already known underlying structural abnormality as cause for the intracerebral haemorrhage (such as arterial venous malformation, aneurysm, tumour, venous thrombosis)
  • Event was secondary to trauma
  • Contra-indication to tranexamic acid
  • Participation in another drug or devices trial concurrently (with the exception of enrolment into the RESTART secondary prevention trial after 21 days)
  • Severe pre-morbid disability (modified Rankin scale is 5)
  • Glasgow Coma Scale less than 5
  • Life expectancy likely to be under 3 months due to other disease (e.g. advanced metastatic cancer)
  • Female patient of childbearing potential, pregnant or breastfeeding
  • Geographical or other factors that prohibit follow-up at 90 days, e.g. no fixed address or telephone contact number, or overseas visitor
Description of interventions Intravenous tranexamic acid: 1g loading dose given as 100 mls infusion over 10 minutes, followed by another 1g in 250 mls infused over 8 hours.  Comparator — matching placebo (normal saline 0.9%) administered by identical regimen.
Duration of study 48 months.
Participants will be followed up for 90 days.
Randomisation and blinding Patients will be randomised (1:1) to receive either tranexamic acid or placebo (0.9 % saline).  Randomisation will be performed by the Stroke Trials Unit (STU) and involve computerised minimisation on key prognostic factors: age; stroke severity; systolic blood pressure.  Patients randomised to placebo will receive intravenous normal saline.  Patients and outcome assessors will be blind to treatment allocation.
Outcome measures Primary outcome:
Death or dependency (modified Rankin Scale, mRS) day 90.

Secondary clinical outcomes:
  • At day 7 (or discharge if sooner), neurological impairment (NIHSS).
  • At day 90, disability (Barthel index), Quality of Life (EuroQol), cognition.
  • At day 365, mRS, disability (Barthel index, Quality of Life (EuroQol), cognition, cognition and mood (TICS and ZDS).
  • Safety: death, serious adverse events, thromboembolic events, seizures.
  • Costs: length of stay in hospital, re-admission, institutionalisation.
  • Radiological efficacy/safety (CT scan): change in haematoma volume from baseline to 24 hours, haematoma location, and new infarction.
Statistical methods Death or dependency (ordinal shift on mRS) at day 90 will be analysed by intention-to-treat using ordinal logistic regression (OLR), with adjustment for minimisation factors.  The assumption of proportional odds will be tested using the likelihood ratio test.  Comparison of tranexamic acid versus control.

Trial Steering Committee
  Chair –Colin Baigent
Members – Nikola Sprigg, Philip Bath, Lelia Duley, Rustam Al-Shahi Salman, Matthew Walters, Ian Roberts, Christine Roffe, Tom Robinson, Rob Dineen, Timothy England, Stuart Pocock, David Whynes, David Werring, Yvo Roos (Netherlands), Angela Shone (sponsor's representative), Christine Knott and Malcolm Jarvis (patients' representatives), Simon Bevan (HTA – funder's representative)
International Advisory Committee
Chair –Nikola Sprigg
UK –Philip Bath
Georgia –Maia Beridze
Italy –Alfonso Ciccone
Romania –Szabolcs Szatmári
Sweden –Ann Charlotte Laska
Trial Management Committee (Nottingham, UK)
Chief investigator –Nikola Sprigg
Co-chief investigator –Philip Bath
Trial manager – Diane Havard
Medics – Jason Appleton and Zhe Kang Law
UK co-ordinator – Christopher Lysons
International co-ordinator – Robert Gray
Outcome co-ordinators – Christopher Lysons, Nadia Frowd and Robert Gray
Statistician –Katie Flaherty
Data/imaging co-ordinator – Mark Sampson
Programming – Lee Haywood and Richard Dooley
Finance –Diane Havard
Secretaries – Monika Kowalczyk and Yvonne Smallwood
Independent Data Monitoring Committee
Chairman –John Bamford (UK)
Members – Martin Bland (UK), Graham Venables (UK)
Statistician –Wei Tan (UK)
Independent Events Adjudicators
Tim England and Amit Mistry
Scan Adjudicators
Rob Dineen (lead), Lesley Cala, Alessandro Adami and Ana Casado
Programming and database management
Lee Haywood and Richard Dooley (UK)

Use of your personal data in research - information for participants

For information about how we use your personal data for RIGHT-2 in accordance with UK data protection laws, please refer to our data protection supplementary information document.

Contact details
Address: Stroke, Division of Clinical Neuroscience,
University of Nottingham
Clinical Sciences Building, North Road
City Hospital Campus, off Hucknall Road
Nottingham NG5 1PB, United Kingdom
Telephone:+44 (0)115 823 1770
Fax:+44 (0)115 823 1771
Email: TICH-2
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