Download Tranexamic acid in IntraCerebral Haemorrhage 2 (TICH-2)

Tranexamic acid for IntraCerebral
Haemorrhage 2 (TICH-2)
ISRCTN93732214
Web: www.tich-2.org
Email: [email protected] Tel: +44 (0)115 8231701 Follow Us on Twitter: @tich2trial
Inclusion
 Adult ≥18 – no upper age limit
 Acute spontaneous intracerebral haemorrhage
 Within 8 hours symptom onset
Exclusion
X Secondary ICH (e.g. anticoagulation, thrombolysis,
aneurysm, AVM, tumour, venous thrombosis or trauma)
X Contra-indication to tranexamic acid
X Pregnant or breastfeeding at randomisation or females of
child bearing potential
X Pre-morbid dependency (mRS >4)
X Glasgow coma scale <5
X Pre stroke life expectancy < 3 months due to other
disease
(e.g. advanced metastatic cancer)
X Geographical factors that inhibit follow up at 90 days
X Participation in another drug/devices trial with the
exception of RESTART (TICH-2 participants can be enrolled in
RESTART after 21 days)
Recruitment Target = 2000 patients
Aims
To assess whether Tranexamic acid is safe and reduces death
and dependency after hyperacute (Within 8 hours of onset)
spontaneous ICH
Design
A phase III prospective pragmatic double blind randomised
placebo controlled trial
Treatment
IV tranexamic acid: 1g loading dose given as 100 mls
infusion over 10 mins, followed by another 1g in 250mls
infused over 8hrs
Outcome
Primary outcome: Death or dependency (mRS) at day 90
Consent
 Can be taken by any appropriately trained health professional.
 Staff must have consent specified on Site Delegation Log which needs to be signed by the Principal
Investigator (PI)
 Consent needs to be detailed in the patient notes.
 Brief consent must be followed up by full consent.
Randomisation
 Randomisation and treatment pack allocation is carried out electronically via the trial website.
Trial Poster v1.0 11/09/15