title: Tranexamic acid for spontaneous intracerebral hemorrhage: a randomized controlled pilot trial (ISRCTN50867461).
abstract: BACKGROUND
  Spontaneous intracerebral hemorrhage (ICH) can be devastating, particularly if hematoma expansion (HE) occurs. Tranexamic acid (TA), an antifibrinolytic drug, significantly reduced mortality in bleeding patients after trauma in the large CRASH-2 trial. The CRASH-2 ICH substudy found that TA nonsignificantly reduced mortality and dependency in traumatic ICH. The aim of this study was to assess the feasibility of performing a randomized controlled trial of tranexamic acid in spontaneous ICH, ahead of a definitive study.
  
  
  METHODS
  We performed a single-center, prospective, randomized (2:1), double-blind, placebo-controlled blinded endpoint trial of TA (intravenous 1 g bolus, 1 g infusion/8 h) in acute (<24 hours) spontaneous ICH. The primary objective was to test the feasibility of recruiting to the trial. Other objectives included tolerability (adverse events) and the effect of TA on HE and death and dependency.
  
  
  RESULTS
  The trial was feasible, with 24 patients enrolled (TA, n=16; placebo, n=8) between March 2011 and March 2012, and acceptable-only 3 patients declined to participate. All patients received the correct randomized treatment; 1 patient in the TA group did not complete the infusion because of neurologic deterioration. There were no significant differences in secondary outcomes including adverse events, HE, death, and dependency. One patient in the TA group had a deep vein thrombosis .
  
  
  CONCLUSIONS
  This, the first randomized controlled trial of TA in ICH, found that the protocol could be delivered on schedule (2 patients/mo) and was feasible. Larger studies are needed to assess safety and efficacy of TA in ICH.
authors.affiliation: Stroke Trials Unit, Division of Clinical Neurosciences, School of Medicine, University of Nottingham, Nottingham, UK. Electronic address: nikola.sprigg@nottingham.ac.uk.
authors.forename: Nikola
authors.initials: N
authors.lastname: Sprigg
authors.affiliation: Stroke Trials Unit, Division of Clinical Neurosciences, School of Medicine, University of Nottingham, Nottingham, UK.
authors.forename: Cheryl J
authors.initials: CJ
authors.lastname: Renton
authors.affiliation: Stroke Trials Unit, Division of Clinical Neurosciences, School of Medicine, University of Nottingham, Nottingham, UK.
authors.forename: Robert A
authors.initials: RA
authors.lastname: Dineen
authors.affiliation: Department of Radiology, Nottingham University Hospitals NHS Trust, Nottingham, UK.
authors.forename: Yune
authors.initials: Y
authors.lastname: Kwong
authors.affiliation: Stroke Trials Unit, Division of Clinical Neurosciences, School of Medicine, University of Nottingham, Nottingham, UK.
authors.forename: Philip M W
authors.initials: PM
authors.lastname: Bath
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000933:Antifibrinolytic Agents / Q000627:therapeutic use*; D002543:Cerebral Hemorrhage / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D014148:Tranexamic Acid / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000933:Antifibrinolytic Agents; D014148:Tranexamic Acid
keywords: Acute stroke; intracerebral hemorrhage; randomized controlled trials; tranexamic acid