title: A Stroke Registry Data on the Use of Intravenous Recombinant Tissue Plasminogen Activator in Stroke of Unknown Time of Onset.
abstract: BACKGROUND
  Stroke of unknown time of onset (SUTO) constitutes one fifth of all ischemic stroke admissions, and routine use of intravenous recombinant tissue plasminogen activator (IV rtPA) is recommended only in patients with a symptom onset time of less than 4.5 hours. There are limited data on clinical outcome in patients with SUTO versus patients with symptoms onset less than 4.5 hours from onset time. We hypothesized that efficacy and safety outcomes of IV rtPA therapy in selected SUTO patients are comparable to those with known onset time.
  
  
  METHODS
  We compared 90 days' modified Rankin Scale (mRS), rates of symptomatic intracerebral hemorrhage (sICH), in-hospital mortality, and death due to sICH between 3 groups treated with IV rtPA: SUTO, 3 hours or less, and 3.0-4.5 hours from prospective patient admissions between April 1, 2012, and July 31, 2013.
  
  
  RESULTS
  There were 65 participants in the SUTO group, 186 in the 3 hours or less group, and 51 in the 3.0-4.5 hours group. In-hospital mortality rates were 14.5%, 13.5%, and 11.8%, respectively. sICH risks were 1.5%, 1.6%, and 5.8%, and death rates due to sICH were 0%, 1.1%, and 1.9%, respectively. Ninety days' odds of excellent clinical outcome (mRS score 0-1) were not different between the SUTO group (odds ratio [OR] 1.14, 95% confidence interval [CI]: .63-2.10), the 3 hours or less group (OR .87, 95% CI: .48-1.60), and the 3.0-4.5 hours group (OR .79, 95% CI: .48-1.60) (P = .82).
  
  
  CONCLUSIONS
  Thrombolytic therapy outcome in SUTO is not different from in-license use in our patient population. There is an urgent need to include this patient group in ongoing randomized multicenter trials.
authors.affiliation: Division of Urgent and Long term Conditions, Department of Stroke Medicine/HCOOP, East Kent Hospitals University NHS Foundation Trust, United Kingdom. Electronic address: Ibrahim.balogun@nhs.net.
authors.forename: Ibrahim O
authors.initials: IO
authors.lastname: Balogun
authors.affiliation: Division of Urgent and Long term Conditions, Department of Stroke Medicine/HCOOP, East Kent Hospitals University NHS Foundation Trust, United Kingdom.
authors.forename: Aaron
authors.initials: A
authors.lastname: Brown
authors.affiliation: Division of Urgent and Long term Conditions, Department of Stroke Medicine/HCOOP, East Kent Hospitals University NHS Foundation Trust, United Kingdom.
authors.forename: Miguel
authors.initials: M
authors.lastname: Bertoni
authors.affiliation: Division of Urgent and Long term Conditions, Department of Stroke Medicine/HCOOP, East Kent Hospitals University NHS Foundation Trust, United Kingdom.
authors.forename: Thomas
authors.initials: T
authors.lastname: Webb
authors.affiliation: Division of Urgent and Long term Conditions, Department of Stroke Medicine/HCOOP, East Kent Hospitals University NHS Foundation Trust, United Kingdom.
authors.forename: David
authors.initials: D
authors.lastname: Hargroves
authors.affiliation: Division of Urgent and Long term Conditions, Department of Stroke Medicine/HCOOP, East Kent Hospitals University NHS Foundation Trust, United Kingdom.
authors.forename: Patrick
authors.initials: P
authors.lastname: Pullicino
mesh_terms: D061605:Administration, Intravenous; D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D016022:Case-Control Studies; D002543:Cerebral Hemorrhage / Q000209:etiology / Q000517:prevention & control; D005260:Female; D005343:Fibrinolytic Agents / Q000008:administration & dosage*; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D012042:Registries; D012189:Retrospective Studies; D020521:Stroke / Q000150:complications / Q000000981:diagnostic imaging / Q000188:drug therapy*; D017216:Telemedicine; D013997:Time Factors; D010959:Tissue Plasminogen Activator / Q000008:administration & dosage*; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome
chemical_list: D005343:Fibrinolytic Agents; D010959:Tissue Plasminogen Activator
keywords: Acute ischemic stroke; in-license treatment; recombinant tissue plasminogen activator; stroke of unknown time of onset