Establishment and Evaluation to the Effects of a Clinical Pathway for Acute Ischemic Stroke - Full Text View

Purpose

The purpose of this study is to determine whether the clinical pathway for acute ischemic stroke(with combination of traditional Chinese medicine and western medicine) is able to improve the outcome of acute ischemic stroke and evaluate its effect on hospital day and cost, etc. Meanwhile, the study will discuss the safety and efficiency of this kind of Clinical Pathway

Condition	Intervention	Phase
Acute Ischemic Stroke	Drug: aspirin，chinese herbs；	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Establishment and Evaluation to the Effects of a Clinical Pathway for Acute Ischemic Stroke

Resource links provided by NLM:

Drug Information available for: Aspirin

U.S. FDA Resources

Further study details as provided by Guangzhou University of Traditional Chinese Medicine:

Primary Outcome Measures:

death rate；average hospital day；cost of hospitalization [ Time Frame: 3 months；discharge day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Modified Rankin Scale (mRS) National Institute of Health Stroke Scale (NIHSS) Barthel Index degree of satisfaction [ Time Frame: 7 day；30 day；3 months ] [ Designated as safety issue: No ]


Enrollment:	314
Study Start Date:	May 2009
Study Completion Date:	January 2011
Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: pathway aspirin，Chinese herbs；acupuncture；rehabilitation；health education；	Drug: aspirin，chinese herbs； aspirin 300mg/100mg,qd,chinese herbs, one dose ，qd Other Name: Bayer

Detailed Description:

Eligibility Ages Eligible for Study: 18 Years to 85 Years Genders Eligible for Study: Both Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

Those clinically diagnosed with acute ischemic stroke ； 18-85 years old； Over 6 hours and within 14 days from onset 4<=NIHSS <=22; Informed consent signed by patient or his/her family ；

Exclusion Criteria:

Hemorrhagic stroke; Cerebral hernia; Serious heart, liver, lung, kidney functional failure，malignancy; Not cooperative with physician; Psychological disorder; Already taken part in other clinical drug trial within the past 3 months

Eligibility


Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Ischemic stroke diagnosed with both criteria of traditional Chinese medicine and western medicine；
18-85 years old；
Over 6 hours and within 14 days from onset
4<=NIHSS <=22;
Informed consent signed by patient or his/her family ；

Exclusion Criteria:

Hemorrhagic stroke;
Cerebral hernia;
Serious heart, liver, lung, kidney functional failure,malignancy;
Not cooperative with physician;
Psychological disorder;
Already taken part in other clinical drug trial within the past 3 months

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00966316

Locations


China, Guangdong
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, China, 510120

Sponsors and Collaborators

Guangzhou University of Traditional Chinese Medicine

Investigators


Study Chair:	yefeng cai, postgraduate	Guangdong Provincial Hospital of Traditional Chinese Medicine

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

Publications:

Adams HP Jr, del Zoppo G, Alberts MJ, Bhatt DL, Brass L, Furlan A, Grubb RL, Higashida RT, Jauch EC, Kidwell C, Lyden PD, Morgenstern LB, Qureshi AI, Rosenwasser RH, Scott PA, Wijdicks EF; American Heart Association/American Stroke Association Stroke Council; American Heart Association/American Stroke Association Clinical Cardiology Council; American Heart Association/American Stroke Association Cardiovascular Radiology and Intervention Council; Atherosclerotic Peripheral Vascular Disease Working Group; Quality of Care Outcomes in Research Interdisciplinary Working Group. Guidelines for the early management of adults with ischemic stroke: a guideline from the American Heart Association/American Stroke Association Stroke Council, Clinical Cardiology Council, Cardiovascular Radiology and Intervention Council, and the Atherosclerotic Peripheral Vascular Disease and Quality of Care Outcomes in Research Interdisciplinary Working Groups: The American Academy of Neurology affirms the value of this guideline as an educational tool for neurologists. Circulation. 2007 May 22;115(20):e478-534. Erratum in: Circulation. 2007 Oct 30;116(18):e515.


Responsible Party:	Yefeng,Cai, Guangdong Provincial Hospital of Chinese Medicine
ClinicalTrials.gov Identifier:	NCT00966316 History of Changes
Other Study ID Numbers:	200707004
Study First Received:	August 25, 2009
Last Updated:	May 14, 2011
Health Authority:	China: Food and Drug Administration

Keywords provided by Guangzhou University of Traditional Chinese Medicine:


Acute Ischemic Stroke；clinical pathway;TCM；

Additional relevant MeSH terms:


Ischemia Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases	Cerebrovascular Disorders Nervous System Diseases Pathologic Processes Vascular Diseases

ClinicalTrials.gov processed this record on March 02, 2015

Establishment and Evaluation to the Effects of a Clinical Pathway for Acute Ischemic Stroke (PAIS)