Clinical trial NCT01758952: Incidence and Risk Factors of Peri-operative Stroke in Non-cardiac,Non-neurosurgical Surgeries
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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peri-operative Stroke
Perioperative Adverse Events
Non-cardiac Surgery
Non-neurosurgical Surgery
Keywords: Peri-operative stroke
incidence
risk factors
prospective
Lead sponsor: Chinese Medical Association
Sponsor class: NETWORK
First posted: 2013-01-01
Enrollment: 10000
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We propose a sample size of 10,000 patients to ensure a stable logistic model for an anticipated stroke rate of 1.0%.

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.

Eligibility criteria: 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

Primary outcomes:
measure: perioperative stroke occurs during and within 30 days after surgery.
timeFrame: 30 days after suegery
Secondary outcomes:
measure: total mortality and other major vascular complications up until 30 days after surgery
timeFrame: 30 days after suegery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chaoyang Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: No.1 Hospital of Peking University
city: Hong Kong
country: China
facility: Prince of Wales Hospital
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
city: Wuhan
country: China
facility: Tongji Hospital, Huazhong University of Science and Technology
city: Xi'an
country: China
facility: Tangdu Hospital, The Fourth Military Medical University
Study officials:
affiliation: Beijing Chao Yang Hospital
name: Yun Yue, MD
role: STUDY_CHAIR
References:
citation: Ng JL, Chan MT, Gelb AW. Perioperative stroke in noncardiac, nonneurosurgical surgery. Anesthesiology. 2011 Oct;115(4):879-90. doi: 10.1097/ALN.0b013e31822e9499.