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

Background and Purpose-The clinical correlates of the varying degrees of ea rly hemorrhagic transformation of a cerebral infarct are unclear. We invest igated 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 (PII) detected within the first 3 6 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 int ravenous recombinant tissue plasminogen activator in acute ischemic stroke. Findings on 24- to 36- hour CT were classified into 5 categories: no hemor rhagic 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 oppo sed to no bleeding. Risks were adjusted for age and extent of ischemic dama ge 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 plasmi nogen 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 w as also higher, but not significantly, after PH2. Conclusions-Risk of early neurological deterioration and of 3-month death w as severely increased after PH2, indicating that large hematoma is the only type of hemorrhagic transformation that may alter the clinical course of i schemic stroke.