Protocol violations in community-based rTPA stroke treatment are associated with symptomatic intracerebral hemorrhage

Alfredo M. Lopez-Yunez, Askiel Bruno, Linda S. Williams, Engin Yilmaz, Cristina Zurrú, José Biller

Research output: Contribution to journalArticle

128 Citations (Scopus)

Abstract

Background - Recombinant tissue plasminogen activator (rTPA) is an established treatment for acute ischemic stroke. The rate and type of protocol violations in rTPA use and their effect on patient outcomes in this setting are not well understood. Objective - The objective of this study was to examine associations between protocol violations and outcomes in community-based rTPA use. Methods - We reviewed medical records of stroke patients treated with rTPA in 10 acute-care hospitals in Indianapolis from July 1996 to February 1998 and assessed complications and outcome. Retrospective National Institute of Health Stroke Scale (on admission and discharge), Canadian Neurological Scale, and length of hospital stay were calculated. Appropriate use of rTPA was determined by the National Institute of Neurological Disorders and Stroke (NINDS) protocol. Results - Fifty patients (mean age, 66 years; 76% white; 56% men) were treated by general neurologists (70%), stroke neurologists (24%), or emergency physicians (6%). Mean times to hospital arrival, brain CT, and start of rTPA infusion were 44, 86, and 141 minutes, respectively. In-hospital mortality rate was 10% (4 intracerebral hemorrhage [ICH], 1 cardiogenic shock). Complications were more frequent among patients with protocol violations (n=8) compared with those without all hemorrhages (75% versus 10%, P<0.001), symptomatic ICH (38% versus 5%, P<0.02), and ICH attributable to rTPA, occurring within 36 hours (38% versus 2.4%, P<0.01), respectively. Conclusions - NINDS protocol violations are relatively common and are associated with symptomatic cerebral and systemic hemorrhages. When the NINDS protocol is strictly followed, hemorrhage rates in community-based rTPA use are similar to those in the NINDS trial.

Original languageEnglish (US)
Pages (from-to)12-16
Number of pages5
JournalStroke
Volume32
Issue number1
DOIs
StatePublished - Jan 1 2001
Externally publishedYes

Fingerprint

Cerebral Hemorrhage
Tissue Plasminogen Activator
Stroke
National Institute of Neurological Disorders and Stroke
Therapeutics
Length of Stay
Hemorrhage
Cardiogenic Shock
National Institutes of Health (U.S.)
Hospital Mortality
Medical Records
Emergencies
Physicians
Mortality
Brain

Keywords

  • Intracerebral hemorrhage
  • Plasminogen activator, tissue-type
  • Stroke, ischemic

ASJC Scopus subject areas

  • Clinical Neurology
  • Cardiology and Cardiovascular Medicine
  • Advanced and Specialized Nursing

Cite this

Protocol violations in community-based rTPA stroke treatment are associated with symptomatic intracerebral hemorrhage. / Lopez-Yunez, Alfredo M.; Bruno, Askiel; Williams, Linda S.; Yilmaz, Engin; Zurrú, Cristina; Biller, José.

In: Stroke, Vol. 32, No. 1, 01.01.2001, p. 12-16.

Research output: Contribution to journalArticle

Lopez-Yunez, Alfredo M. ; Bruno, Askiel ; Williams, Linda S. ; Yilmaz, Engin ; Zurrú, Cristina ; Biller, José. / Protocol violations in community-based rTPA stroke treatment are associated with symptomatic intracerebral hemorrhage. In: Stroke. 2001 ; Vol. 32, No. 1. pp. 12-16.
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abstract = "Background - Recombinant tissue plasminogen activator (rTPA) is an established treatment for acute ischemic stroke. The rate and type of protocol violations in rTPA use and their effect on patient outcomes in this setting are not well understood. Objective - The objective of this study was to examine associations between protocol violations and outcomes in community-based rTPA use. Methods - We reviewed medical records of stroke patients treated with rTPA in 10 acute-care hospitals in Indianapolis from July 1996 to February 1998 and assessed complications and outcome. Retrospective National Institute of Health Stroke Scale (on admission and discharge), Canadian Neurological Scale, and length of hospital stay were calculated. Appropriate use of rTPA was determined by the National Institute of Neurological Disorders and Stroke (NINDS) protocol. Results - Fifty patients (mean age, 66 years; 76{\%} white; 56{\%} men) were treated by general neurologists (70{\%}), stroke neurologists (24{\%}), or emergency physicians (6{\%}). Mean times to hospital arrival, brain CT, and start of rTPA infusion were 44, 86, and 141 minutes, respectively. In-hospital mortality rate was 10{\%} (4 intracerebral hemorrhage [ICH], 1 cardiogenic shock). Complications were more frequent among patients with protocol violations (n=8) compared with those without all hemorrhages (75{\%} versus 10{\%}, P<0.001), symptomatic ICH (38{\%} versus 5{\%}, P<0.02), and ICH attributable to rTPA, occurring within 36 hours (38{\%} versus 2.4{\%}, P<0.01), respectively. Conclusions - NINDS protocol violations are relatively common and are associated with symptomatic cerebral and systemic hemorrhages. When the NINDS protocol is strictly followed, hemorrhage rates in community-based rTPA use are similar to those in the NINDS trial.",
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T1 - Protocol violations in community-based rTPA stroke treatment are associated with symptomatic intracerebral hemorrhage

AU - Lopez-Yunez, Alfredo M.

AU - Bruno, Askiel

AU - Williams, Linda S.

AU - Yilmaz, Engin

AU - Zurrú, Cristina

AU - Biller, José

PY - 2001/1/1

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N2 - Background - Recombinant tissue plasminogen activator (rTPA) is an established treatment for acute ischemic stroke. The rate and type of protocol violations in rTPA use and their effect on patient outcomes in this setting are not well understood. Objective - The objective of this study was to examine associations between protocol violations and outcomes in community-based rTPA use. Methods - We reviewed medical records of stroke patients treated with rTPA in 10 acute-care hospitals in Indianapolis from July 1996 to February 1998 and assessed complications and outcome. Retrospective National Institute of Health Stroke Scale (on admission and discharge), Canadian Neurological Scale, and length of hospital stay were calculated. Appropriate use of rTPA was determined by the National Institute of Neurological Disorders and Stroke (NINDS) protocol. Results - Fifty patients (mean age, 66 years; 76% white; 56% men) were treated by general neurologists (70%), stroke neurologists (24%), or emergency physicians (6%). Mean times to hospital arrival, brain CT, and start of rTPA infusion were 44, 86, and 141 minutes, respectively. In-hospital mortality rate was 10% (4 intracerebral hemorrhage [ICH], 1 cardiogenic shock). Complications were more frequent among patients with protocol violations (n=8) compared with those without all hemorrhages (75% versus 10%, P<0.001), symptomatic ICH (38% versus 5%, P<0.02), and ICH attributable to rTPA, occurring within 36 hours (38% versus 2.4%, P<0.01), respectively. Conclusions - NINDS protocol violations are relatively common and are associated with symptomatic cerebral and systemic hemorrhages. When the NINDS protocol is strictly followed, hemorrhage rates in community-based rTPA use are similar to those in the NINDS trial.

AB - Background - Recombinant tissue plasminogen activator (rTPA) is an established treatment for acute ischemic stroke. The rate and type of protocol violations in rTPA use and their effect on patient outcomes in this setting are not well understood. Objective - The objective of this study was to examine associations between protocol violations and outcomes in community-based rTPA use. Methods - We reviewed medical records of stroke patients treated with rTPA in 10 acute-care hospitals in Indianapolis from July 1996 to February 1998 and assessed complications and outcome. Retrospective National Institute of Health Stroke Scale (on admission and discharge), Canadian Neurological Scale, and length of hospital stay were calculated. Appropriate use of rTPA was determined by the National Institute of Neurological Disorders and Stroke (NINDS) protocol. Results - Fifty patients (mean age, 66 years; 76% white; 56% men) were treated by general neurologists (70%), stroke neurologists (24%), or emergency physicians (6%). Mean times to hospital arrival, brain CT, and start of rTPA infusion were 44, 86, and 141 minutes, respectively. In-hospital mortality rate was 10% (4 intracerebral hemorrhage [ICH], 1 cardiogenic shock). Complications were more frequent among patients with protocol violations (n=8) compared with those without all hemorrhages (75% versus 10%, P<0.001), symptomatic ICH (38% versus 5%, P<0.02), and ICH attributable to rTPA, occurring within 36 hours (38% versus 2.4%, P<0.01), respectively. Conclusions - NINDS protocol violations are relatively common and are associated with symptomatic cerebral and systemic hemorrhages. When the NINDS protocol is strictly followed, hemorrhage rates in community-based rTPA use are similar to those in the NINDS trial.

KW - Intracerebral hemorrhage

KW - Plasminogen activator, tissue-type

KW - Stroke, ischemic

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