title: Intravenous tranexamic acid for hyperacute primary intracerebral hemorrhage: Protocol for a randomized, placebo-controlled trial.
abstract: Outcome after intracerebral hemorrhage remains poor. Tranexamic acid is easy to administer, readily available, inexpensive, and effective in other hemorrhagic conditions.
  
  
  
  This randomized trial aims to test the hypothesis that intravenous tranexamic acid given within 8 h of spontaneous intracerebral hemorrhage reduces death or dependency.
  
  
  
  Phase III prospective double-blind randomized placebo-controlled trial. Participants within 8 h of spontaneous intracerebral hemorrhage are randomized to receive either intravenous tranexamic acid 1 g 10 min bolus followed by 1 g 8 h infusion, or placebo.
  
  
  
  A trial of 2000 participants (300 from start-up phase and 1700 from main phase) will have 90% power to detect an ordinal shift of the modified Rankin Scale with odds ratio 0.79.
  
  
  
  The primary outcome is death or dependency measured by ordinal shift analysis of the 7 level mRS at day 90. Secondary outcomes are neurological impairment at day 7 and disability, quality of life, cognition, and mood at day 90. Safety outcomes are death, serious adverse events, thromboembolic events, and seizures. Cost outcomes are length of stay in hospital, readmission, and institutionalization.
  
  
  
  This pragmatic trial is assessing efficacy of tranexamic acid after spontaneous intracerebral hemorrhage. Recruitment started in 2013; as of 15th January 2016 1355 participants have been enrolled, from 95 centers in seven countries. Recruitment is due to end in 2017. TICH-2 Trial is registered as ISRCTN93732214.
authors.affiliation: Stroke, Division of Clinical Neuroscience, Nottingham, UK Nikola.sprigg@nottingham.ac.uk.
authors.forename: Nikola
authors.initials: N
authors.lastname: Sprigg
authors.affiliation: Stroke, Division of Clinical Neuroscience, Nottingham, UK.
authors.forename: Katie
authors.initials: K
authors.lastname: Robson
authors.affiliation: Stroke, Division of Clinical Neuroscience, Nottingham, UK.
authors.forename: Philip
authors.initials: P
authors.lastname: Bath
authors.affiliation: Stroke, Division of Clinical Neuroscience, Nottingham, UK.
authors.forename: Robert
authors.initials: R
authors.lastname: Dineen
authors.affiliation: Stroke, Division of Clinical Neuroscience, Nottingham, UK.
authors.forename: Ian
authors.initials: I
authors.lastname: Roberts
authors.affiliation: Stroke, Division of Clinical Neuroscience, Nottingham, UK.
authors.forename: Tom
authors.initials: T
authors.lastname: Robinson
authors.affiliation: Stroke, Division of Clinical Neuroscience, Nottingham, UK.
authors.forename: Christine
authors.initials: C
authors.lastname: Roffe
authors.affiliation: Stroke, Division of Clinical Neuroscience, Nottingham, UK.
authors.forename: David
authors.initials: D
authors.lastname: Werring
authors.affiliation: Stroke, Division of Clinical Neuroscience, Nottingham, UK.
authors.forename: Rustam
authors.initials: R
authors.lastname: Al-Shahi Salman
authors.affiliation: Stroke, Division of Clinical Neuroscience, Nottingham, UK.
authors.forename: Stuart
authors.initials: S
authors.lastname: Pocock
authors.affiliation: Stroke, Division of Clinical Neuroscience, Nottingham, UK.
authors.forename: Lelia
authors.initials: L
authors.lastname: Duley
authors.affiliation: Stroke, Division of Clinical Neuroscience, Nottingham, UK.
authors.forename: Tim
authors.initials: T
authors.lastname: England
authors.affiliation: Stroke, Division of Clinical Neuroscience, Nottingham, UK.
authors.forename: David
authors.initials: D
authors.lastname: Whynes
authors.affiliation: Stroke, Division of Clinical Neuroscience, Nottingham, UK.
authors.forename: Alfonso
authors.initials: A
authors.lastname: Ciccone
authors.affiliation: Stroke, Division of Clinical Neuroscience, Nottingham, UK.
authors.forename: Ann Charlotte
authors.initials: AC
authors.lastname: Laska
authors.affiliation: Stroke, Division of Clinical Neuroscience, Nottingham, UK.
authors.forename: Hanne
authors.initials: H
authors.lastname: Christensen
authors.affiliation: Stroke, Division of Clinical Neuroscience, Nottingham, UK.
authors.forename: Serefnur
authors.initials: S
authors.lastname: Ozturk
authors.affiliation: Stroke, Division of Clinical Neuroscience, Nottingham, UK.
authors.forename: Ronan
authors.initials: R
authors.lastname: Collins
authors.affiliation: Stroke, Division of Clinical Neuroscience, Nottingham, UK.
authors.forename: Daniel
authors.initials: D
authors.lastname: Bereczki
authors.affiliation: Stroke, Division of Clinical Neuroscience, Nottingham, UK.
authors.forename: Juan Jose
authors.initials: JJ
authors.lastname: Egea-Guerrero
authors.affiliation: Stroke, Division of Clinical Neuroscience, Nottingham, UK.
authors.forename: Zhe Kang
authors.initials: ZK
authors.lastname: Law
authors.affiliation: Stroke, Division of Clinical Neuroscience, Nottingham, UK.
authors.forename: Anna
authors.initials: A
authors.lastname: Czlonkowska
authors.affiliation: Stroke, Division of Clinical Neuroscience, Nottingham, UK.
authors.forename: David
authors.initials: D
authors.lastname: Seiffge
authors.affiliation: Stroke, Division of Clinical Neuroscience, Nottingham, UK.
authors.forename: Maia
authors.initials: M
authors.lastname: Beredzie
mesh_terms: D061605:Administration, Intravenous; D000339:Affect / Q000187:drug effects; D000933:Antifibrinolytic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002543:Cerebral Hemorrhage / Q000188:drug therapy* / Q000523:psychology; D003071:Cognition / Q000187:drug effects; D004185:Disability Evaluation; D006801:Humans; D007902:Length of Stay; D010359:Patient Readmission; D011788:Quality of Life; D012720:Severity of Illness Index; D016037:Single-Blind Method; D014148:Tranexamic Acid / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000933:Antifibrinolytic Agents; D014148:Tranexamic Acid
keywords: Hyperacute intracerebral hemorrhage; placebo controlled; randomized trial; tranexamic acid