A Registry Study of Shuxuening Injection Used in Hospitals in China

NCT01752946 | Unknown DMC

• 1 other identifier: 2009zx09502-030-07
• Study Type: observational
• Target: 30,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is get to know what and how Shuxuening injection in hospital results in adverse events or adverse drug reactions from a cohort event monitoring.

Conditions

Coronary Disease; Intracranial Embolism; Stroke; Angina Pectoris; Vasospasm

Outcome Measures

Primary Outcomes (1)

• Incidence of Shuxuening injection's ADRs and factors contributed to the occurrence of the adverse reaction

  All participants will be followed for the duration of hospital stay, an expected average of 2 weeks. Patients using Shuxuening will be registered on a registration form including disease background, Shuxuening's administration, and extraction information from hospital information system. When the patients occurs allergic reaction during using Shuxuening injection, it also need to collect patient's biological samples. An adverse event or drug adverse reaction form also will be used to describe any doubted symptoms or signs from patients. A judgment will be made by doctors directly and a further analysis will be conducted by researchers to decide those potential side-effects of Shuxuening injection.

  to assess Shuxuening's "adverse event" and "drug adverse reaction" during patients' hospital stay, administration information of Shuxuening will be registered every day. The registry procedure will last 2 years only for patients using Shuxuening.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

According to the 'rule of three', 30,000 cases need to be registered at least. The aim population is who using Shuxuening injection's during inpatient time from December 2012 to December.2014 in more than 30 hospitals in China.

You may qualify if:

• Patients using Shuxuening injection from 2012 to 2014

You may not qualify if:

• none

Sponsors & Collaborators

• China Academy of Chinese Medical Sciences: lead
• Beijing University of Chinese Medicine: collaborator

MeSH Terms

Conditions

Coronary Disease; Intracranial Embolism; Stroke; Angina Pectoris

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Intracranial Embolism and Thrombosis; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Thromboembolism; Embolism and Thrombosis; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yan M Xie, BA

  Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director

Study Record Dates

• First Submitted: December 15, 2012
• First Posted: December 19, 2012
• Study Start: October 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 20, 2012

Record last verified: 2012-12