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

C

Chinese Medical Association

Status

Unknown

Conditions

Non-cardiac Surgery
Perioperative Adverse Events
Non-neurosurgical Surgery
Peri-operative Stroke

Study type

Observational

Funder types

NETWORK

Identifiers

NCT01758952
Peri-operativeStroke

Details and patient eligibility

About

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.

Full 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.

Enrollment

10,000 estimated patients

Sex

All

Ages

60+ years old

Volunteers

No 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

Trial design

10,000 participants in 6 patient groups

Beijing Chaoyang Hospital
Description:
2000 cases
Peking University Hospital
Description:
2000 cases
Zhongshan Hospital of Fudan University
Description:
2000 cases
Tongji Hospital, Wuhan
Description:
2000 cases
Tangdu Hospital, Xi'an
Description:
2000 cases
The Prince Welsh Hospital
Description:
1000 cases

Trial contacts and locations

6

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Central trial contact

Yun Yue, MD; Zhuonan Sun, MD

Data sourced from clinicaltrials.gov

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