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Delayed Vasospasm After Aneurysm With the Standardization Treatment of Traditional Chinese Medicine

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Guangzhou University of Traditional Chinese Medicine
Sponsor:
Information provided by (Responsible Party):
Guangzhou University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT01840761
First received: December 12, 2011
Last updated: April 25, 2013
Last verified: April 2013
  Purpose

Delayed vasospasm (DCVS) is the most serious complication of aneurysmal subarachnoid hemorrhage (aSAH) perioperative period ,the incidence rate up to 30% to 90%, and often can cause severe brain ischemia or brain damage of delayed ischemic and even lead to cerebral infarction, to be the main factor of deadly and severe disability . (aSAH) perioperative delayed vasospasm (CVS) is the bottleneck to restrict the long-term effect. Since there is no standard clinical treatment programs, limiting the advantages and characteristics of traditional Chinese medicine to play.Guangdong Provincial Hospital of TCM is the province's Medical Center encephalopathy, treated 100 brain aneurysm patients each year, more than 80 times craniotomies and surgical interventions , with a rich source of patiengs to carry out the study. In this study, on the basis studies on hemorrhagic stroke of a yin and yang syndrome and comprehensive treatment programe of the State 1995,the 15th research , in accordance with characteristics of the pathophysiology and understanding of cause and pathogenesis in aSAH perioperative period , through expert advice and review of the literature, under the guidance of Liu Maocai who isChinese medicine practitioners of Guangdong province , from diagnosis, diagnosis and treatment,prescription drugs, and other aspects of efficacy evaluation, developmenting a standardized treatment program of delayed CVS after aSAH . To evaluate the efficacy of the standardized program by prospective, randomized,controlled clinical trial,improving the postoperative results, reducting significantly the mortality and morbidity patients with cerebral aneurysms.


Condition Intervention Phase
Aneurysm
Drug: herbal drug
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Delayed Vasospasm After Aneurysm With the Standardization Treatment of Traditional Chinese Medicine

Resource links provided by NLM:


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

Primary Outcome Measures:
  • The incidence of DCVS after aneurysmal postoperative [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    after 3-months chinese medicine treatment, through evaluating the incidence of delayed vasospasm after cerebral aneurysms , to assess the efficacy of Chinese medicine


Secondary Outcome Measures:
  • 1 month, 3 month mortality [ Time Frame: 14days,1 month,3 month ] [ Designated as safety issue: Yes ]
    after 3-months chinese medicine treatment, through evaluating 1 month, 3 month mortality after cerebral aneurysms , to assess the efficacy of Chinese medicine


Estimated Enrollment: 60
Study Start Date: July 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: herbal drug
Traditional Chinese herbal drug
Drug: herbal drug
Placebo Comparator: Placebo Drug: placebo

  Eligibility

Ages Eligible for Study:   14 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Between the ages of 14-80 years old patients;
  • Comply with the diagnostic criteria for Chinese and Western medicine;
  • Comply with embolization of intracranial aneurysms or cranial aneurysm surgery indications;
  • Preoperative Hunt and Hess grade of Ⅰ ~ Ⅳ; The first disease or previous history of stroke but no sequelae;
  • Acceptance within 72h onset cranial aneurysm embolization or craniotomy aneurysm surgeon;
  • Informed consent;

Exclusion Criteria:

  • The age of 14 years of age or in patients over 80 years of age;
  • By hypertension, a variety of blood diseases, amyloid angiopathy, cerebral arteritis, cerebral abnormal vascular network (moyamoya disease), brain tumor brain metastases as a result of bleeding;
  • Associated with cardiovascular, liver and kidney and hematopoietic system of primary disease, mental illness;
  • 72h of onset did not receive cranial aneurysm embolization or craniotomy for aneurysm surgery were;
  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: NCT01840761

Locations
China, Guangdong
Guangdong Provincial Science and Technology Agency Recruiting
Guangzhou, Guangdong, China, 510033
Contact: jianwen Guo, dr.    020-81887233 ext 34530    jianwen_guo@msn.com   
Principal Investigator: Jianwen Guo, Dr.         
Sponsors and Collaborators
Guangzhou University of Traditional Chinese Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Guangzhou University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT01840761     History of Changes
Other Study ID Numbers: 2010B030700029, 2010B030700029
Study First Received: December 12, 2011
Last Updated: April 25, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Guangzhou University of Traditional Chinese Medicine:
delayed vasospasm,
medicine,
standardization

Additional relevant MeSH terms:
Aneurysm
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014