NCT01758952

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2012

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 23, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 1, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

July 16, 2020

Status Verified

November 1, 2013

Enrollment Period

3 years

First QC Date

December 23, 2012

Last Update Submit

July 15, 2020

Conditions

Peri-operative StrokePerioperative Adverse EventsNon-cardiac SurgeryNon-neurosurgical Surgery

Keywords

Peri-operative strokeincidencerisk factorsprospective

Outcome Measures

Primary Outcomes (1)

  • perioperative stroke occurs during and within 30 days after surgery.

    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.

    30 days after suegery

Secondary Outcomes (1)

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

    30 days after suegery

Study Arms (6)

Beijing Chaoyang Hospital

2000 cases

Peking University Hospital

2000 cases

Zhongshan Hospital of Fudan University

2000 cases

Tongji Hospital, Wuhan

2000 cases

Tangdu Hospital, Xi'an

2000 cases

The Prince Welsh Hospital

1000 cases

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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%.

You may qualify if:

  • Ages Eligible for Study: 60 Years and older
  • Genders Eligible for Study: Both
  • Accepts Healthy Volunteers: No
  • Sampling Method: Probability Sample

You may not qualify if:

  • hospital stay after surgery less than 3 days
  • not consent of the assessment
  • surgery canceled

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Beijing Chaoyang Hospital, Capital Medical University

Beijing, Beijing Municipality, 100013, China

RECRUITING

No.1 Hospital of Peking University

Beijing, China

ENROLLING BY INVITATION

Prince of Wales Hospital

Hong Kong, China

RECRUITING

Zhongshan Hospital, Fudan University

Shanghai, China

ENROLLING BY INVITATION

Tongji Hospital, Huazhong University of Science and Technology

Wuhan, China

ENROLLING BY INVITATION

Tangdu Hospital, The Fourth Military Medical University

Xi'an, China

ENROLLING BY INVITATION

Related Publications (1)

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

    PMID: 21862923BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, white cells

Study Officials

  • Yun Yue, MD

    Beijing Chao Yang Hospital

    STUDY CHAIR

Central Study Contacts

Yun Yue, MD

CONTACT

8610-13701275595yueyun@hotmail.com

Zhuonan Sun, MD

CONTACT

8610-18701052470szn19_lucky5566@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2012

First Posted

January 1, 2013

Study Start

March 1, 2012

Primary Completion

March 1, 2015

Study Completion

March 1, 2021

Last Updated

July 16, 2020

Record last verified: 2013-11

Locations

CN(6)