Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00314

2 Trial Registration Date

2012-02-28

i Registration Status

Prospective

3 Secondary IDs

N/A

4 Source(s) of Funding

Departmental

5 Primary Sponsor

CUHK

6 Secondary Sponsor

N/A

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Matthew Chan

ii Address

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong, 4/F Main Clinical Block and Trauma Centre, Prince of Wales Hospital

iii Phone

2632 2736

iv Email

mtvchan@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Matthew Chan

ii Address

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong, 4/F Main Clinical Block and Trauma Centre, Prince of Wales Hospital

iii Phone

2632 2736

iv Email

mtvchan@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

Prospective Observational Study of Perioperative Stroke: A Pilot Study

10 Public Title

Prospective Observational Study of Perioperative Stroke: A Pilot Study

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Perioperative stroke Survey

12 Countries of Recruitment

Hong Kong, Beijing, China

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2012-02-07

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Anesthesia, adverse effects from general anesthesia, stroke, noncardiac surgery

15 Intervention

i Types of intervention

Other

Please specify

Anesthesia

ii Description/ name of Intervention/article

Anesthesia/Surgery

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

During Surgery

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

N/A

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

(1) Patients scheduled for noncardiac, non-neurological surgery receiving general and/or regional anesthetic
(2) Requiring at least 3 nights of hospital stay

ii Exclusion Criteria

(1) Patients receiving only simple infiltrative (i.e. local) or topical anesthesia.
(2) Patients previously enrolled in the study and patients who do not consent to participate will also be excluded

iii Age Minimum

60

iv Age Maximum

N/A

v Gender

Both Male and Female

18 Study Type

Observational

19 Study Design

i Randomization

Non-randomized

Please specify

ii Nature of control

Uncontrolled

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Single group

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2012-03-01

21 Target Sample Size

1000

22 Recruitment Status

Unknown

23 Primary Outcome

Stroke within 30 days after surgery

24 Secondary Outcome

Perioperative major cardiovascular complications (including myocardial infarction, pulmonary embolism, arrhythmias, congestive heart failure, cardiac death)

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2015-04-06

27 Primary Registry and Trial Identifying Number

ChiCTR-ONC-12002073

28 Date of Registration in Primary Registry

2012-04-04

Back History

Trial Detail