title: The spot sign and tranexamic acid on preventing ICH growth--AUStralasia Trial (STOP-AUST): protocol of a phase II randomized, placebo-controlled, double-blind, multicenter trial.
abstract: BACKGROUND
  No evidence-based acute therapies exist for intracerebral hemorrhage. Intracerebral hemorrhage growth is an important determinant of patient outcome. Tranexamic acid is known to reduce hemorrhage in other conditions.
  
  
  OBJECTIVE
  The study aims to test the hypothesis that intracerebral hemorrhage patients selected with computed tomography angiography contrast extravasation 'spot sign' will have lower rates of hematoma growth when treated with intravenous tranexamic acid within 4.5-hours of stroke onset compared with placebo.
  
  
  METHODS
  The Spot sign and Tranexamic acid On Preventing ICH growth--AUStralasia Trial is a multicenter, prospective, 1:1 randomized, double-blind, placebo-controlled, investigator-initiated, academic Phase II trial. Intracerebral hemorrhage patients fulfilling clinical criteria (e.g. Glasgow Coma Scale >7, intracerebral hemorrhage volume <70 ml, no identified secondary cause of intracerebral hemorrhage, no thrombotic events within the previous 12 months, no planned surgery) and demonstrating contrast extravasation on computed tomography angiography will receive either intravenous tranexamic acid 1 g 10-min bolus followed by 1 g eight-hour infusion or placebo. A second computed tomography will be performed at 24 ± 3 hours to evaluate intracerebral hemorrhage growth and patients followed up for three-months.
  
  
  RESULTS
  The primary outcome measure is presence of intracerebral hemorrhage growth by 24 ± 3 hours, defined as either >33% or >6 ml increase from baseline, and will be adjusted for baseline intracerebral hemorrhage volume. Secondary outcome measures include growth as a continuous measure, thromboembolic events, and the three-month modified Rankin Scale score.
  
  
  CONCLUSIONS
  This is the first trial to evaluate the efficacy of tranexamic acid in intracerebral hemorrhage patients selected based on an imaging biomarker of high likelihood of hematoma growth. The trial is registered as NCT01702636.
authors: Department of Medicine, University of Melbourne, Parkville, Victoria, Australia; Department of Neurology, The Royal Melbourne Hospital, Parkville, Victoria, Australia; The Florey Institute of Neuroscience and Mental Health, Parkville, Victoria, Australia; Department of Neurology, Helsinki University Central Hospital, Helsinki, Finland.
authors: Atte
authors: A
authors: Meretoja
authors: Leonid
authors: L
authors: Churilov
authors: Bruce C V
authors: BC
authors: Campbell
authors: Richard I
authors: RI
authors: Aviv
authors: Nawaf
authors: N
authors: Yassi
authors: Christen
authors: C
authors: Barras
authors: Peter
authors: P
authors: Mitchell
authors: Bernard
authors: B
authors: Yan
authors: Harshal
authors: H
authors: Nandurkar
authors: Christopher
authors: C
authors: Bladin
authors: Tissa
authors: T
authors: Wijeratne
authors: Neil J
authors: NJ
authors: Spratt
authors: Jim
authors: J
authors: Jannes
authors: Jonathan
authors: J
authors: Sturm
authors: Jayantha
authors: J
authors: Rupasinghe
authors: Jorge
authors: J
authors: Zavala
authors: Andrew
authors: A
authors: Lee
authors: Timothy
authors: T
authors: Kleinig
authors: Romesh
authors: R
authors: Markus
authors: Candice
authors: C
authors: Delcourt
authors: Neil
authors: N
authors: Mahant
authors: Mark W
authors: MW
authors: Parsons
authors: Christopher
authors: C
authors: Levi
authors: Craig S
authors: CS
authors: Anderson
authors: Geoffrey A
authors: GA
authors: Donnan
authors: Stephen M
authors: SM
authors: Davis
mesh_terms: D000328:Adult; D000368:Aged; D000933:Antifibrinolytic Agents / Q000627:therapeutic use*; D001315:Australia; D002533:Cerebral Angiography; D002543:Cerebral Hemorrhage / Q000150:complications* / Q000188:drug therapy*; D003287:Contrast Media; D004311:Double-Blind Method; D005260:Female; D006406:Hematoma / Q000209:etiology* / Q000517:prevention & control*; D006801:Humans; D008297:Male; D008875:Middle Aged; D014057:Tomography, X-Ray Computed; D014148:Tranexamic Acid / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000933:Antifibrinolytic Agents; D003287:Contrast Media; D014148:Tranexamic Acid
keywords: ICH; intracerebral hemorrhage; spot sign; tranexamic acid