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

Recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Trial Design

  • Observation: Cohort
  • Perspective: Prospective
  • Sampling: Probability Sample

Trial Population

We propose a sample size of 10,000 patients to ensure a stable logistic model for an anticipated stroke rate of 1.0%.

Outcomes

Type Measure Time Frame Safety Issue
Primary perioperative stroke occurs during and within 30 days after surgery. 30 days after suegery No
Secondary total mortality and other major vascular complications up until 30 days after surgery 30 days after suegery No

Biospecimen Retention:Samples With DNA - whole blood, serum, white cells

Sponsors