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

Sponsor

Chinese Medical Association (Other)

Overall Status

Unknown status

CT.gov ID

NCT01758952

Collaborator

(none)

10,000

Enrollment

Locations

108

Duration (Months)

1666.7

Patients Per Site

15.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Peri-operative Stroke Perioperative Adverse Events Non-cardiac Surgery Non-neurosurgical 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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

10000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Multi-center Prospective Investigation of Incidence and Risk Factors of Peri-operative Stroke in Non-cardiac,Non-neurosurgical Surgeries and Practicability of NIHSS in Screening Peri-operative Strokes

Study Start Date :

Mar 1, 2012

Actual Primary Completion Date :

Mar 1, 2015

Anticipated Study Completion Date :

Mar 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Beijing Chaoyang Hospital 2000 cases
Peking University Hospital 2000 cases
Zhongshan Hospital of Fudan University 2000 cases
Tongji Hospital, Wuhan 2000 cases
Tangdu Hospital, Xi'an 2000 cases
The Prince Welsh Hospital 1000 cases

Outcome Measures

Primary Outcome Measures

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

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: Myocardial infarction is defined according to recent universal definition of myocardial infarction; Nonfatal cardiac arrest is a successful resuscitation from either documented or presumed ventricular fibrillation or sustained ventricular tachycardia or asystole; Pulmonary embolism; Congestive heart failure is defined by both clinical and radiographic evidence; 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; 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Chaoyang Hospital, Capital Medical University	Beijing	Beijing	China	100013
2	No.1 Hospital of Peking University	Beijing		China
3	Prince of Wales Hospital	Hong Kong		China
4	Zhongshan Hospital, Fudan University	Shanghai		China
5	Tongji Hospital, Huazhong University of Science and Technology	Wuhan		China
6	Tangdu Hospital, The Fourth Military Medical University	Xi'an		China