Incidence and Risk Factors of Peri-operative Stroke in Non-cardiac,Non-neurosurgical Surgeries

• Conditions: Non-cardiac Surgery; Non-neurosurgical Surgery; Peri-operative Stroke; Perioperative Adverse Events

• Registration Number: NCT01758952
• Lead Sponsor: Chinese Medical Association

Brief Summary

Stroke is an important cause of perioperative morbidity and mortality, particularly in patients \> 60 years. In cardiac, neurological and carotid surgery the incidence is known to be high (2.2-5.2%). However, little is known regarding perioperative stroke following other types of surgery including general, urological, orthopedic, thoracic and gynecological procedures. We therefore propose to undertake a multicenter, observational cohort study, to determine the current incidence of, the risk factors for, and outcome associated with perioperative stroke in patients undergoing non-cardiac and non-neurological surgery.

Detailed Description

Patient population: Prospective cohort study of 10,000 adults undergoing non-cardiac, non-neurological surgery.

Screening and enrollment: Consecutive patients undergoing (elective or emergency) non-cardiac, non-neurosurgical surgeries will be recruited.

Monitoring, follow-up, and data collection: Usual treatment will be provided. Demographic details will be recorded. Patients will be visited regularly in hospital. Patient will be reviewed for neurologic deficit using the mNIHSS. Brain imaging will be performed to confirm stroke event. Follow-up at 30 days after discharge will be done to ascertain if there is any adverse outcome.

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-12-23
• Study First Submitted QC: 2012-12-31
• Study First Posted: 2013-01-01
• Status Verified: 2013-11
• Primary Completion: 2015-03
• Last Update Submitted: 2020-07-15
• Last Update Posted: 2020-07-16
• Study Completion: 2021-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

• Ages Eligible for Study: 60 Years and older
• Genders Eligible for Study: Both
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Exclusion Criteria

• hospital stay after surgery less than 3 days
• not consent of the assessment
• surgery canceled

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
perioperative stroke occurs during and within 30 days after surgery.	30 days after suegery	The primary outcome is perioperative stroke occurs during and within 30 days after surgery. This is defined as cerebral infarction or hemorrhage on computer tomography or magnetic resonance scan, or new neurological signs (paralysis, weakness or speech difficulties) lasting more than 24 hours or leading to death. The mechanism of stroke will be classified using the Trial of Org 10172 in Acute Stroke Treatment (TOAST) criteria.

Secondary Outcome Measures

Name	Time	Method
total mortality and other major vascular complications up until 30 days after surgery	30 days after suegery	Secondary outcomes include total mortality and other major vascular complications up until 30 days after surgery: 1. Myocardial infarction is defined according to recent universal definition of myocardial infarction; 2. Nonfatal cardiac arrest is a successful resuscitation from either documented or presumed ventricular fibrillation or sustained ventricular tachycardia or asystole; 3. Pulmonary embolism; 4. Congestive heart failure is defined by both clinical and radiographic evidence; 5. Clinically significant atrial fibrillation is defined as atrial fibrillation that results in angina, congestive heart failure, symptomatic hypotension, or that requires treatment with a rate controlling drug, antiarrhythmic drug, or electrical cardioversion; 6. Cardiac death: defined as any death with a cardiovascular cause, including deaths following a cardiovascular procedure, cardiac arrest, myocardial infarction, pulmonary embolus, stroke, hemorrhage, or deaths due to unknown cause.

Trial Locations

Locations (6)

Prince of Wales Hospital; 🇨🇳 Hong Kong, China

Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, China

Tongji Hospital, Huazhong University of Science and Technology; 🇨🇳 Wuhan, China

Tangdu Hospital, The Fourth Military Medical University; 🇨🇳 Xi'an, China

Beijing Chaoyang Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

No.1 Hospital of Peking University; 🇨🇳 Beijing, China