EBQ:Tissue Plasminogen Activator for Acute Ischemic Stroke - Revision history

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2026-03-21T22:11:02Z

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	\| fulltexturl=http://www.nejm.org/doi/full/10.1056/NEJM199512143332401		\| fulltexturl=http://www.nejm.org/doi/full/10.1056/NEJM199512143332401
	\| pdfurl=http://www.nejm.org/doi/pdf/10.1056/NEJM199512143332401		\| pdfurl=http://www.nejm.org/doi/pdf/10.1056/NEJM199512143332401
			\| status = Complete
	}}		}}

Mholtz: Mholtz moved page NINDS to EBQ:Tissue Plasminogen Activator for Acute Ischemic Stroke

2017-07-12T23:36:30Z

Mholtz moved page NINDS to EBQ:Tissue Plasminogen Activator for Acute Ischemic Stroke

← Revisión anterior	Revisión del 23:36 12 jul 2017
(Sin diferencias)

Mholtz at 23:35, 12 July 2017

2017-07-12T23:35:41Z

← Revisión anterior		Revisión del 23:35 12 jul 2017
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	==Clinical Question==		==Clinical Question==
	*Two part study		*Two part study
	**tPA versus placebo		*tPA versus placebo
	**Does tPA have clinical activity which was measured as improvement of 4 points on the NIHSS or resolution of neurologic deficit within 24 hours of onset?		*#Does tPA have clinical activity which was measured as improvement of 4 points on the NIHSS or resolution of neurologic deficit within 24 hours of onset?
			*#What are the clinical outcomes at 3 months based on Barthel index, modified Rankin scale, Glasgow outcome scale and NIHSS?

	**What are the clinical outcomes at 3 months based on Barthel index, modified Rankin scale, Glasgow outcome scale and NIHSS?		==Conclusion==

	==Conclusion==
	*No significant differences in neurologic improvement at 24 hours between two groups.		*No significant differences in neurologic improvement at 24 hours between two groups.
	*At three months, improved neurologic outcome in tPA group		*At three months, improved neurologic outcome in tPA group
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	==Major Points==		==Major Points==

	*tPA has greater risk of hemorrhagic transformation however, in patients who received tPA they were more likely to have less of a neurologic disability at 3 months.		*tPA has greater risk of hemorrhagic transformation however, in patients who received tPA they were more likely to have less of a neurologic disability at 3 months.


	==Study Design==		==Study Design==

	*Permutated- block design for randomization stratified based on clinical center and time from onset of stroke to start of treatment		*Permutated- block design for randomization stratified based on clinical center and time from onset of stroke to start of treatment
	*Multicenter clinical trial		*Multicenter clinical trial
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	==Population==		==Population==

	*all patients with ischemic stroke with clearly defined onset, deficit measured on NIHSS and baseline CT with no evidence of ICH		*all patients with ischemic stroke with clearly defined onset, deficit measured on NIHSS and baseline CT with no evidence of ICH


	*624 patients from January 1991 through October 1994 who presented to one of the eight geographically diverse academic centers in the United States		*624 patients from January 1991 through October 1994 who presented to one of the eight geographically diverse academic centers in the United States

	===Patient Demographics===		===Patient Demographics===

	''No differences were detected between treatment groups in baseline characteristics''		''No differences were detected between treatment groups in baseline characteristics''
	{\| class="wikitable"		{\| class="wikitable"
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	===Inclusion Criteria===		===Inclusion Criteria===

	*ischemic stroke with clearly defined onset		*ischemic stroke with clearly defined onset
	*deficit measured on NIHSS		*deficit measured on NIHSS
	*baseline CT with no evidence of ICH		*baseline CT with no evidence of ICH


	===Exclusion Criteria===		===Exclusion Criteria===
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	==Interventions==		==Interventions==

	*tPA IV 0.9 mg/kg with 10% given as a bolus and 90% given over 60 minutes after the bolus		*tPA IV 0.9 mg/kg with 10% given as a bolus and 90% given over 60 minutes after the bolus

	==Outcomes==		==Outcomes==
	===Primary Outcome===		===Primary Outcome===

	*Part 1: > 4 point improvement in NIHSS at 24 hours		*Part 1: > 4 point improvement in NIHSS at 24 hours
	N = 291		N = 291
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	===Secondary Outcomes===		===Secondary Outcomes===

	*Lower rate of hemorrhage compared to trials with streptokinase and t-PA		*Lower rate of hemorrhage compared to trials with streptokinase and t-PA
	*recommend to mimized blood pressure elevations		*recommend to mimized blood pressure elevations
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	**tPA: 6.4% (20/312)		**tPA: 6.4% (20/312)
	**Placebo: 0.64% (2/312)		**Placebo: 0.64% (2/312)


	*Asymptomatic ICH		*Asymptomatic ICH
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	==Criticisms & Further Discussion==		==Criticisms & Further Discussion==

	*Imbalance in the stroke subtypes		*Imbalance in the stroke subtypes
	*Placebo had more large vessel occlusive strokes than tPA		*Placebo had more large vessel occlusive strokes than tPA
	*fragility index of 3 which is the number of outcomes that could be changed which causes a loss of statistical significance which is a very low number <ref> https://emcrit.org/pulmcrit/fragility-index-ninds/ </ref>		*fragility index of 3 which is the number of outcomes that could be changed which causes a loss of statistical significance which is a very low number <ref> https://emcrit.org/pulmcrit/fragility-index-ninds/ </ref>


	==External Links==		==External Links==

	https://emcrit.org/emcrit/tpa-for-ischemic-stroke-debate/		https://emcrit.org/emcrit/tpa-for-ischemic-stroke-debate/


	==Funding==		==Funding==
	National Institute of Neurological Disorders and Stroke		National Institute of Neurological Disorders and Stroke


	==References==		==References==

Panosiaa at 19:27, 12 July 2017

2017-07-12T19:27:13Z

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Ostermayer at 05:43, 13 November 2013

2013-11-13T05:43:23Z

← Revisión anterior		Revisión del 05:43 13 nov 2013
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	\| abbreviation=NINDS		\| abbreviation=NINDS
	\| expansion=National Institute of Neurological Disorders and Stroke rt-PA Stroke Study		\| expansion=National Institute of Neurological Disorders and Stroke rt-PA Stroke Study
	\| published=1995~~-12-14~~		\| published=1995
	\| author=~~Marler JR, et al~~		\| author=Neurological Disorders and Stroke Stroke Study Group
	\| journal=The New England Journal of Medicine		\| journal=The New England Journal of Medicine
	\| year=1995		\| year=1995

Ostermayer at 05:37, 13 November 2013

2013-11-13T05:37:55Z

← Revisión anterior		Revisión del 05:37 13 nov 2013
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	{{info		{{JC info
	\| title= Tissue Plasminogen Activator for Acute Ischemic Stroke		\| title= Tissue Plasminogen Activator for Acute Ischemic Stroke
	\| abbreviation=NINDS		\| abbreviation=NINDS

Ostermayer: Created page with "{{info | title= Tissue Plasminogen Activator for Acute Ischemic Stroke | abbreviation=NINDS | expansion=National Institute of Neurological Disorders and Stroke rt-PA Stroke St..."

2013-11-13T05:37:38Z

Created page with "{{info | title= Tissue Plasminogen Activator for Acute Ischemic Stroke | abbreviation=NINDS | expansion=National Institute of Neurological Disorders and Stroke rt-PA Stroke St..."

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{{info
| title= Tissue Plasminogen Activator for Acute Ischemic Stroke
| abbreviation=NINDS
| expansion=National Institute of Neurological Disorders and Stroke rt-PA Stroke Study
| published=1995-12-14
| author=Marler JR, et al
| journal=The New England Journal of Medicine
| year=1995
| volume=333
| issue=24
| pages=1581-1587
| pmid= 7477192
| fulltexturl=http://www.nejm.org/doi/full/10.1056/NEJM199512143332401
| pdfurl=http://www.nejm.org/doi/pdf/10.1056/NEJM199512143332401
}}