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Thrombolytic removal of intraventricular haemorrhage in treatment of severe stroke: results of the randomised, multicentre, multiregion, placebo-controlled CLEAR III trial

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  • معلومة اضافية
    • Affiliation:
      a Johns Hopkins University, School of Medicine, Brain Injury Outcomes Division, Baltimore, MD, USA
      b Icahn School of Medicine at Mount Sinai, New York, NY, USA
      c University of Glasgow, Glasgow, UK
      d University of Maryland, Baltimore, MD, USA
      e Emissary International LLC, Austin, TX, USA
      f Newcastle University, Newcastle upon Tyne, UK
      g University of Alberta, Edmonton, AB, Canada
      h University of California, Los Angeles, CA, USA
      i Emory University, Atlanta, GA, USA
      j Boston University, Boston, MA, USA
      k Johns Hopkins University Bloomberg School of Public Health, Department of Biostatistics, Baltimore, MD, USA
      l National Institutes of Health, National institute of Neurological Disorders and Stroke, Bethesda, MD, USA
      m Rush University, Chicago, IL, USA
      n Chaim Sheba Medical Center, Ramat Gan, Israel
      o University of Texas, Houston, Houston, TX, USA
      p University of Alabama at Birmingham, Birmingham, AL, USA
      q University of Utah, Salt Lake City, UT, USA
      r Thomas Jefferson University Hospital, Philadelphia, PA, USA
      s University of Texas, San Antonio, San Antonio, TX, USA
      t North Shore Long Island Jewish Medical Center, Manhasset, NY, USA
      u University of Cincinnati, Cincinnati, OH, USA
      v University of Iowa, Iowa City, IA, USA
      w University of Chicago, Chicago, IL, USA
    • Subject Terms:
    • Abstract:
      Summary Background Intraventricular haemorrhage is a subtype of intracerebral haemorrhage, with 50% mortality and serious disability for survivors. We aimed to test whether attempting to remove intraventricular haemorrhage with alteplase versus saline irrigation improved functional outcome.
    • Abstract:
      Findings Between Sept 18, 2009, and Jan 13, 2015, 500 patients were randomised: 249 to the alteplase group and 251 to the saline group. 180-day follow-up data were available for analysis from 246 of 249 participants in the alteplase group and 245 of 251 participants in the placebo group. The primary efficacy outcome was similar in each group (good outcome in alteplase group 48% vs saline 45%; risk ratio [RR] 1·06 [95% CI 0·88–1·28; p=0·554]). A difference of 3·5% (RR 1·08 [95% CI 0·90–1·29], p=0·420) was found after adjustment for intraventricular haemorrhage size and thalamic intracerebral haemorrhage. At 180 days, the treatment group had lower case fatality (46 [18%] vs saline 73 [29%], hazard ratio 0·60 [95% CI 0·41–0·86], p=0·006), but a greater proportion with mRS 5 (42 [17%] vs 21 [9%]; RR 1·99 [95% CI 1·22–3·26], p=0·007). Ventriculitis (17 [7%] alteplase vs 31 [12%] saline; RR 0·55 [95% CI 0·31–0·97], p=0·048) and serious adverse events (114 [46%] alteplase vs 151 [60%] saline; RR 0·76 [95% CI 0·64–0·90], p=0·002) were less frequent with alteplase treatment. Symptomatic bleeding (six [2%] in the alteplase group vs five [2%] in the saline group; RR 1·21 [95% CI 0·37–3·91], p=0·771) was similar.
    • Abstract:
      Interpretation In patients with intraventricular haemorrhage and a routine extraventricular drain, irrigation with alteplase did not substantially improve functional outcomes at the mRS 3 cutoff compared with irrigation with saline. Protocol-based use of alteplase with extraventricular drain seems safe. Future investigation is needed to determine whether a greater frequency of complete intraventricular haemorrhage removal via alteplase produces gains in functional status.
    • Abstract:
      Funding National Institute of Neurological Disorders and Stroke.
    • ISSN:
      0140-6736
    • Accession Number:
      10.1016/S0140-6736(16)32410-2
    • Accession Number:
      S0140673616324102
    • Copyright:
      © 2017 Elsevier Ltd. All rights reserved.
  • Citations
    • ABNT:
      HANLEY, D. F. et al. Thrombolytic removal of intraventricular haemorrhage in treatment of severe stroke: results of the randomised, multicentre, multiregion, placebo-controlled CLEAR III trial. The Lancet, [s. l.], v. 389, n. 10069, p. 603–611, 2017. DOI 10.1016/S0140-6736(16)32410-2. Disponível em: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=edselp&AN=S0140673616324102&custid=s8280428. Acesso em: 21 fev. 2020.
    • AMA:
      Hanley DF, Lane K, McBee N, et al. Thrombolytic removal of intraventricular haemorrhage in treatment of severe stroke: results of the randomised, multicentre, multiregion, placebo-controlled CLEAR III trial. The Lancet. 2017;389(10069):603-611. doi:10.1016/S0140-6736(16)32410-2.
    • APA:
      Hanley, D. F., Lane, K., McBee, N., Ziai, W., Tuhrim, S., Lees, K. R., Dawson, J., Gandhi, D., Ullman, N., Mould, W. A., Mayo, S. W., Mendelow, A. D., Gregson, B., Butcher, K., Vespa, P., Wright, D. W., Kase, C. S., Carhuapoma, J. R., Keyl, P. M., … Awad, I. A. (2017). Thrombolytic removal of intraventricular haemorrhage in treatment of severe stroke: results of the randomised, multicentre, multiregion, placebo-controlled CLEAR III trial. The Lancet, 389(10069), 603–611. https://doi.org/10.1016/S0140-6736(16)32410-2
    • Chicago/Turabian: Author-Date:
      Hanley, Daniel F, Karen Lane, Nichol McBee, Wendy Ziai, Stanley Tuhrim, Kennedy R Lees, Jesse Dawson, et al. 2017. “Thrombolytic Removal of Intraventricular Haemorrhage in Treatment of Severe Stroke: Results of the Randomised, Multicentre, Multiregion, Placebo-Controlled CLEAR III Trial.” The Lancet 389 (10069): 603–11. doi:10.1016/S0140-6736(16)32410-2.
    • Harvard:
      Hanley, D. F. et al. (2017) ‘Thrombolytic removal of intraventricular haemorrhage in treatment of severe stroke: results of the randomised, multicentre, multiregion, placebo-controlled CLEAR III trial’, The Lancet, 389(10069), pp. 603–611. doi: 10.1016/S0140-6736(16)32410-2.
    • Harvard: Australian:
      Hanley, DF, Lane, K, McBee, N, Ziai, W, Tuhrim, S, Lees, KR, Dawson, J, Gandhi, D, Ullman, N, Mould, WA, Mayo, SW, Mendelow, AD, Gregson, B, Butcher, K, Vespa, P, Wright, DW, Kase, CS, Carhuapoma, JR, Keyl, PM, Diener-West, M, Muschelli, J, Betz, JF, Thompson, CB, Sugar, EA, Yenokyan, G, Janis, S, John, S, Harnof, S, Lopez, GA, Aldrich, EF, Harrigan, MR, Ansari, S, Jallo, J, Caron, J-L, LeDoux, D, Adeoye, O, Zuccarello, M, Adams, JHP, Rosenblum, M, Thompson, RE & Awad, IA 2017, ‘Thrombolytic removal of intraventricular haemorrhage in treatment of severe stroke: results of the randomised, multicentre, multiregion, placebo-controlled CLEAR III trial’, The Lancet, vol. 389, no. 10069, pp. 603–611, viewed 21 February 2020, .
    • MLA:
      Hanley, Daniel F., et al. “Thrombolytic Removal of Intraventricular Haemorrhage in Treatment of Severe Stroke: Results of the Randomised, Multicentre, Multiregion, Placebo-Controlled CLEAR III Trial.” The Lancet, vol. 389, no. 10069, Feb. 2017, pp. 603–611. EBSCOhost, doi:10.1016/S0140-6736(16)32410-2.
    • Chicago/Turabian: Humanities:
      Hanley, Daniel F, Karen Lane, Nichol McBee, Wendy Ziai, Stanley Tuhrim, Kennedy R Lees, Jesse Dawson, et al. “Thrombolytic Removal of Intraventricular Haemorrhage in Treatment of Severe Stroke: Results of the Randomised, Multicentre, Multiregion, Placebo-Controlled CLEAR III Trial.” The Lancet 389, no. 10069 (February 11, 2017): 603–11. doi:10.1016/S0140-6736(16)32410-2.
    • Vancouver/ICMJE:
      Hanley DF, Lane K, McBee N, Ziai W, Tuhrim S, Lees KR, et al. Thrombolytic removal of intraventricular haemorrhage in treatment of severe stroke: results of the randomised, multicentre, multiregion, placebo-controlled CLEAR III trial. The Lancet [Internet]. 2017 Feb 11 [cited 2020 Feb 21];389(10069):603–11. Available from: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=edselp&AN=S0140673616324102&custid=s8280428