title: Hemorrhagic transformation within 36 hours of a cerebral infarct: relationships with early clinical deterioration and 3-month outcome in the European Cooperative Acute Stroke Study I (ECASS I) cohort.
abstract: OBJECTIVE
  The clinical correlates of the varying degrees of early hemorrhagic transformation of a cerebral infarct are unclear. We investigated the cohort of a randomized trial of thrombolysis to assess the early and late clinical course associated with different subtypes of hemorrhagic infarction (HI) and parenchymal hematoma (PH) detected within the first 36 hours of an ischemic stroke.
  
  
  METHODS
  We exploited the database of the European Cooperative Acute Stroke Study I (ECASS I), a randomized, placebo-controlled, phase III trial of intravenous recombinant tissue plasminogen activator in acute ischemic stroke. Findings on 24- to 36- hour CT were classified into 5 categories: no hemorrhagic transformation, HI types 1 and 2, and PH types 1 and 2. We assessed the risk of concomitant neurological deterioration and of 3-month death and disability associated with subtypes of hemorrhagic transformation, as opposed to no bleeding. Risks were adjusted for age and extent of ischemic damage on baseline CT.
  
  
  RESULTS
  Compared with absence of hemorrhagic transformation, HI1, HI2, and PH1 did not modify the risk of early neurological deterioration, death, and disability, whereas, in both the placebo and the recombinant tissue plasminogen activator groups, PH2 had a devastating impact on early neurological course (odds ratio for deterioration, 32.3; 95% CI, 13. 4 to 77.7), and on 3-month death (odds ratio, 18.0; 95% CI, 8.05 to 40.1). Risk of disability was also higher, but not significantly, after PH2.
  
  
  CONCLUSIONS
  Risk of early neurological deterioration and of 3-month death was severely increased after PH2, indicating that large hematoma is the only type of hemorrhagic transformation that may alter the clinical course of ischemic stroke.
authors.affiliation: Department of Neurological Science, University La Sapienza, Rome, Italy. fiorelli@uniroma1.it
authors.forename: M
authors.initials: M
authors.lastname: Fiorelli
authors.forename: S
authors.initials: S
authors.lastname: Bastianello
authors.forename: R
authors.initials: R
authors.lastname: von Kummer
authors.forename: G J
authors.initials: GJ
authors.lastname: del Zoppo
authors.forename: V
authors.initials: V
authors.lastname: Larrue
authors.forename: E
authors.initials: E
authors.lastname: Lesaffre
authors.forename: A P
authors.initials: AP
authors.lastname: Ringleb
authors.forename: S
authors.initials: S
authors.lastname: Lorenzano
authors.forename: C
authors.initials: C
authors.lastname: Manelfe
authors.forename: L
authors.initials: L
authors.lastname: Bozzao
mesh_terms: D000367:Age Factors; D002545:Brain Ischemia / Q000150:complications; D002543:Cerebral Hemorrhage / Q000145:classification / Q000209:etiology*; D002544:Cerebral Infarction / Q000188:drug therapy*; D015331:Cohort Studies; D004311:Double-Blind Method; D005260:Female; D005343:Fibrinolytic Agents / Q000627:therapeutic use; D005500:Follow-Up Studies; D006406:Hematoma / Q000209:etiology; D006801:Humans; D007275:Injections, Intravenous; D008297:Male; D009460:Neurologic Examination; D010919:Placebos; D011994:Recombinant Proteins; D012307:Risk Factors; D020521:Stroke / Q000209:etiology; D015912:Thrombolytic Therapy; D013997:Time Factors; D010959:Tissue Plasminogen Activator / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D005343:Fibrinolytic Agents; D010919:Placebos; D011994:Recombinant Proteins; D010959:Tissue Plasminogen Activator