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

Primary Purpose

Acute Ischemic Stroke

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
aspirin,chinese herbs;
Sponsored by
Guangzhou University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke focused on measuring Acute Ischemic Stroke;clinical pathway;TCM;

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Guangdong Provincial Hospital of Chinese Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

pathway

Arm Description

aspirin,Chinese herbs;acupuncture;rehabilitation;health education;

Outcomes

Primary Outcome Measures

death rate;average hospital day;cost of hospitalization

Secondary Outcome Measures

Modified Rankin Scale (mRS) National Institute of Health Stroke Scale (NIHSS) Barthel Index degree of satisfaction

Full Information

First Posted
August 25, 2009
Last Updated
May 14, 2011
Sponsor
Guangzhou University of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00966316
Brief Title
Establishment and Evaluation to the Effects of a Clinical Pathway for Acute Ischemic Stroke
Acronym
PAIS
Official Title
Establishment and Evaluation to the Effects of a Clinical Pathway for Acute Ischemic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Guangzhou University of Traditional Chinese Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke
Keywords
Acute Ischemic Stroke;clinical pathway;TCM;

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
314 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pathway
Arm Type
Experimental
Arm Description
aspirin,Chinese herbs;acupuncture;rehabilitation;health education;
Intervention Type
Drug
Intervention Name(s)
aspirin,chinese herbs;
Other Intervention Name(s)
Bayer
Intervention Description
aspirin 300mg/100mg,qd,chinese herbs, one dose ,qd
Primary Outcome Measure Information:
Title
death rate;average hospital day;cost of hospitalization
Time Frame
3 months;discharge day
Secondary Outcome Measure Information:
Title
Modified Rankin Scale (mRS) National Institute of Health Stroke Scale (NIHSS) Barthel Index degree of satisfaction
Time Frame
7 day;30 day;3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
yefeng cai, postgraduate
Organizational Affiliation
Guangdong Provincial Hospital of Traditional Chinese Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Guangdong Provincial Hospital of Chinese Medicine
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
17515473
Citation
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. doi: 10.1161/CIRCULATIONAHA.107.181486. Erratum In: Circulation. 2007 Oct 30;116(18):e515.
Results Reference
result
Links:
URL
http://www.gdhtcm.com/
Description
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Establishment and Evaluation to the Effects of a Clinical Pathway for Acute Ischemic Stroke

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