Sarah E Nelson1, W Andrew Mould2, Dheeraj Gandhi3, Richard E Thompson4, Sarah Salter4, Rachel Dlugash2, Issam A Awad5, Daniel F Hanley1,2, Wendy Ziai1. 1. Departments of Neurology and Anesthesiology/Critical Care Medicine, 1466Johns Hopkins University, Baltimore, MD, USA. 2. Division of Brain Injury Outcomes, 1466Johns Hopkins University, Baltimore, MD, USA. 3. Department of Diagnostic Radiology and Nuclear Medicine, University of Maryland, Baltimore, MD, USA. 4. Department of Biostatistics, 1466Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, USA. 5. Section of Neurosurgery, University of Chicago, Chicago, IL, USA.
Abstract
BACKGROUND: Intraventricular hemorrhage occurs due to intracerebral hemorrhage with intraventricular extension or without apparent parenchymal involvement, known as primary intraventricular hemorrhage. AIMS: We evaluated the prognosis of primary intraventricular hemorrhage patients in the CLEAR III trial (Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage). METHODS: In patients with primary intraventricular hemorrhage versus those with secondary intraventricular hemorrhage, we compared intraventricular alteplase response and outcomes including modified Rankin Scale, Barthel Index, National Institutes of Health Stroke Scale (NIHSS), and extended Glasgow Outcome Scale (eGOS) at 30, 180, and 365 days. Outcomes were also compared in primary intraventricular hemorrhage patients who received intraventricular alteplase versus placebo (normal saline) and in matched primary and secondary intraventricular hemorrhage patients using inverse-probability-weighted regression adjustment. RESULTS: Of 500 patients enrolled in CLEAR III, 46 (9.2%) had primary intraventricular hemorrhage. Combining both treatment groups, primary intraventricular hemorrhage patients had larger intraventricular hemorrhage volumes (median: 34.2 mL vs. 20.8 mL, p < 0.01) but similar intraventricular hemorrhage removal (51.0% vs. 59.0%, p = 0.24) compared to secondary intraventricular hemorrhage patients, respectively. Confirming previous studies, primary intraventricular hemorrhage patients achieved better NIHSS, modified Rankin Scale, Barthel Index, and eGOS scores at days 30, 180, and 365, respectively (all p < 0.01), although mortality was similar to secondary intraventricular hemorrhage patients; matching analysis yielded similar results. Primary intraventricular hemorrhage patients who received intraventricular alteplase (n = 19) and saline (n = 27) achieved similar outcomes. CONCLUSIONS: In CLEAR III, primary intraventricular hemorrhage patients who survived achieved better long-term outcomes than surviving secondary intraventricular hemorrhage patients with similar mortality. Outcomes and safety were similar between primary intraventricular hemorrhage patients receiving alteplase and those receiving saline.
RCT Entities:
BACKGROUND:Intraventricular hemorrhage occurs due to intracerebral hemorrhage with intraventricular extension or without apparent parenchymal involvement, known as primary intraventricular hemorrhage. AIMS: We evaluated the prognosis of primary intraventricular hemorrhagepatients in the CLEAR III trial (Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage). METHODS: In patients with primary intraventricular hemorrhage versus those with secondary intraventricular hemorrhage, we compared intraventricular alteplase response and outcomes including modified Rankin Scale, Barthel Index, National Institutes of Health Stroke Scale (NIHSS), and extended Glasgow Outcome Scale (eGOS) at 30, 180, and 365 days. Outcomes were also compared in primary intraventricular hemorrhagepatients who received intraventricular alteplase versus placebo (normal saline) and in matched primary and secondary intraventricular hemorrhagepatients using inverse-probability-weighted regression adjustment. RESULTS: Of 500 patients enrolled in CLEAR III, 46 (9.2%) had primary intraventricular hemorrhage. Combining both treatment groups, primary intraventricular hemorrhagepatients had larger intraventricular hemorrhage volumes (median: 34.2 mL vs. 20.8 mL, p < 0.01) but similar intraventricular hemorrhage removal (51.0% vs. 59.0%, p = 0.24) compared to secondary intraventricular hemorrhagepatients, respectively. Confirming previous studies, primary intraventricular hemorrhagepatients achieved better NIHSS, modified Rankin Scale, Barthel Index, and eGOS scores at days 30, 180, and 365, respectively (all p < 0.01), although mortality was similar to secondary intraventricular hemorrhagepatients; matching analysis yielded similar results. Primary intraventricular hemorrhagepatients who received intraventricular alteplase (n = 19) and saline (n = 27) achieved similar outcomes. CONCLUSIONS: In CLEAR III, primary intraventricular hemorrhagepatients who survived achieved better long-term outcomes than surviving secondary intraventricular hemorrhagepatients with similar mortality. Outcomes and safety were similar between primary intraventricular hemorrhagepatients receiving alteplase and those receiving saline.
Authors: Daniel F Hanley; Karen Lane; Nichol McBee; Wendy Ziai; Stanley Tuhrim; Kennedy R Lees; Jesse Dawson; Dheeraj Gandhi; Natalie Ullman; W Andrew Mould; Steven W Mayo; A David Mendelow; Barbara Gregson; Kenneth Butcher; Paul Vespa; David W Wright; Carlos S Kase; J Ricardo Carhuapoma; Penelope M Keyl; Marie Diener-West; John Muschelli; Joshua F Betz; Carol B Thompson; Elizabeth A Sugar; Gayane Yenokyan; Scott Janis; Sayona John; Sagi Harnof; George A Lopez; E Francois Aldrich; Mark R Harrigan; Safdar Ansari; Jack Jallo; Jean-Louis Caron; David LeDoux; Opeolu Adeoye; Mario Zuccarello; Harold P Adams; Michael Rosenblum; Richard E Thompson; Issam A Awad Journal: Lancet Date: 2017-01-10 Impact factor: 79.321
Authors: Wendy C Ziai; Eric Melnychuk; Carol B Thompson; Issam Awad; Karen Lane; Daniel F Hanley Journal: Crit Care Med Date: 2012-05 Impact factor: 7.598
Authors: Timothy C Morgan; Jesse Dawson; Danielle Spengler; Kennedy R Lees; Chanel Aldrich; Nishant K Mishra; Karen Lane; Terence J Quinn; Marie Diener-West; Christopher J Weir; Peter Higgins; Mark Rafferty; Katie Kinsley; Wendy Ziai; Issam Awad; Matthew R Walters; Daniel Hanley Journal: Stroke Date: 2013-01-31 Impact factor: 7.914