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

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.

Study Overview

• Status: Unknown
• Conditions: Aneurysm
• Intervention / Treatment: Drug: placebo; Drug: herbal drug

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510033
      • Recruiting
      • Guangdong Provincial Science and Technology Agency
      • Contact: jianwen Guo, dr.; Phone Number: 34530 020-81887233; Email: jianwen_guo@msn.com
      • Principal Investigator: Jianwen Guo, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: placebo
Experimental: herbal drug; Traditional Chinese herbal drug	Drug: herbal drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of DCVS after aneurysmal postoperative	after 3-months chinese medicine treatment, through evaluating the incidence of delayed vasospasm after cerebral aneurysms , to assess the efficacy of Chinese medicine	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1 month, 3 month mortality	after 3-months chinese medicine treatment, through evaluating 1 month, 3 month mortality after cerebral aneurysms , to assess the efficacy of Chinese medicine	14days,1 month,3 month

Collaborators and Investigators

• Sponsor: Guangzhou University of Traditional Chinese Medicine

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: December 12, 2011
• First Submitted That Met QC Criteria: April 25, 2013
• First Posted (Estimate): April 26, 2013

Study Record Updates

• Last Update Posted (Estimate): April 26, 2013
• Last Update Submitted That Met QC Criteria: April 25, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: standardization; delayed vasospasm,; medicine,
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm
• Other Study ID Numbers: 2010B030700029 (Other Grant/Funding Number: China Guangdong Provincial Science and Technology Agency)