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

NCT ID: NCT01758952

Last Updated: 2020-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2021-03-31

Brief Summary

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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

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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

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Beijing Chaoyang Hospital

2000 cases

No interventions assigned to this group

Peking University Hospital

2000 cases

No interventions assigned to this group

Zhongshan Hospital of Fudan University

2000 cases

No interventions assigned to this group

Tongji Hospital, Wuhan

2000 cases

No interventions assigned to this group

Tangdu Hospital, Xi'an

2000 cases

No interventions assigned to this group

The Prince Welsh Hospital

1000 cases

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese Medical Association

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yun Yue, MD

Role: STUDY_CHAIR

Beijing Chao Yang Hospital

Locations

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Beijing Chaoyang Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status RECRUITING

No.1 Hospital of Peking University

Beijing, , China

Site Status ENROLLING_BY_INVITATION

Prince of Wales Hospital

Hong Kong, , China

Site Status RECRUITING

Zhongshan Hospital, Fudan University

Shanghai, , China

Site Status ENROLLING_BY_INVITATION

Tongji Hospital, Huazhong University of Science and Technology

Wuhan, , China

Site Status ENROLLING_BY_INVITATION

Tangdu Hospital, The Fourth Military Medical University

Xi'an, , China

Site Status ENROLLING_BY_INVITATION

Countries

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China

Central Contacts

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Yun Yue, MD

Role: CONTACT

8610-13701275595

Zhuonan Sun, MD

Role: CONTACT

8610-18701052470

Facility Contacts

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Yun Yue, MD

Role: primary

8610-13701275595

Zhuonan Sun, MD

Role: backup

8610-18701052470

Matthew Chan, M.D.

Role: primary

852-263-22894 ext. 2736

Keung Tat Lee

Role: backup

852-2632-6067

References

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Ng JL, Chan MT, Gelb AW. Perioperative stroke in noncardiac, nonneurosurgical surgery. Anesthesiology. 2011 Oct;115(4):879-90. doi: 10.1097/ALN.0b013e31822e9499.

Reference Type BACKGROUND
PMID: 21862923 (View on PubMed)

Other Identifiers

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Peri-operativeStroke

Identifier Type: -

Identifier Source: org_study_id

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