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Clinical Trials/NCT01758952
NCT01758952
Unknown
Not Applicable

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

Chinese Medical Association6 sites in 1 country10,000 target enrollmentMarch 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Peri-operative Stroke
Sponsor
Chinese Medical Association
Enrollment
10000
Locations
6
Primary Endpoint
perioperative stroke occurs during and within 30 days after surgery.
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2012
End Date
March 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

perioperative stroke occurs during and within 30 days after surgery.

Time Frame: 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 Outcomes

  • total mortality and other major vascular complications up until 30 days after surgery(30 days after suegery)

Study Sites (6)

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