TICH-2 logo

TICH-2 trial - Tranexamic acid for IntraCerebral Haemorrhage 2

  • The trial is funded by the NIHR HTA
  • The trial opened in March 2013 and will run until February 2018
  • The University of Nottingham is acting as trial sponsor
  • The trial is live and recruitment is ongoing, with 1,682 participants so far
  • Start up phase — March 2013
  • Main phase — April 2014
  • New sites welcome in the UK and internationally
For further information please contact us.
 
Trial Managers: Diane Havard
Hayley Foster
Chief Investigator: Dr Nikola Sprigg
Nottingham Stroke Trials Office:

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

TICH-2 has been adopted by the Injuries and Emergencies Network, in addition to the Stroke Research Network.

The protocol paper has been published online in the International Journal of Stroke.
  • Read the protocol paper (PDF) – published online on 20 April 2016

Live database

Go to http://tich-2.org/live/ and use the ID and PIN given to you in your activation email.

You should have set your own password already.
 
Demonstration database

For practice, go to http://tich-2.org/demo/ and use the following credentials.

Userdemoinv1
Password nottingham
PIN8888
 

Title Tranexamic acid for hyperacute primary IntraCerebral Haemorrhage (TICH-2)
Acronym TICH-2
Short title Tranexamic acid for intracerebral haemorrhage (TICH-2)
Chief investigator Dr 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)
Exclusions
  • 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 Managers – Diane Havard, Hayley Foster
Medic –Jason Appleton
UK Co-ordinators – Margaret Adrian, Michael Stringer and Jamie Longmate
International Co-ordinators – Joanne Keeling and James Kirby
Outcome Co-ordinators – Joanne Keeling (lead) and James Kirby
Statistician –Katie Robson
Data/Imaging Co-ordinator – Mark Sampson
Programming – Lee Haywood and Richard Dooley
Finance –Wim Clarke
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 Adjudicator
Rob Dineen
Programming and database management
Lee Haywood and Richard Dooley (UK)



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
Other documents