Perioperative Ischemia Versus Perioperative Bleeding Duri... | NCT01897220

Studies
Perioperative Ischemia Versus Perioperative Bleeding During Non-cardiac Surgery in Cardiac Patients

NCT01897220

Sponsor

Charles University, Czech Republic

Status

Completed

Last Update Posted

Feb 1, 2019Actual

Enrollment

1,200Actual

Phase

Not provided

Conditions

Surgical Procedure, Non-cardiac
Cardiovascular Disease Patients
Perioperative Period

Interventions

Not provided

Countries

Czechia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2011

Primary Completion Date

Jun 2013Actual

Completion Date

Jun 2013Actual

First Submitted Date

Jun 27, 2013

First Submission Date that Met QC Criteria

Jul 10, 2013

First Posted Date

Jul 11, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 30, 2019

Last Update Posted Date

Feb 1, 2019Actual

Name	Class
Ministry of Health, Czech Republic	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of the study is to analyze the present use of antithrombotic therapy on a large cohort of consecutive cardiacs undergoing non-cardiac surgery. If even and for how long the medication was discontinued, if any other antithrombotic therapy was used in the perioperative period and prevalence of perioperative complications - especially ischemic or bleeding. These complications will be correlated with the pattern of antithrombotic therapy administration. Working hypothesis is to obtain a large database of unselected cohort of consecutive patients for mapping of this practically important, but in the evidence-based medicine, still neglected problem.

Detailed Description

This project will closely describe (prospective registry) the present situation (anti-thrombotic medication, prevalence of bleeding and ischemic complication) in a large consecutive cohort of non-selected cardiac patients, who are undergoing non-cardiac surgery.

Patients have to meet all three inclusion criteria: (1) Any kind of non-cardiac surgery (acute or elective) performed under general or neuraxial anaesthesia in four surgical departments - General surgery, Orthopedics-Trauma, Urology and Neurosurgery. (2) History of cardiac disease with risk of arterial, intracardiac or vein thrombosis or embolism. (3) Signed Informed consent. All operated patients who meet the inclusion criteria will get enrolled, i.e. all consecutive cardiacs, who signed Informed consent.

Baseline clinical indicators, chronic and perioperative medication, ECG, laboratory tests and all complications (especially ischemic and bleeding) will be registered.

Participants will be followed for the duration of hospital stay, an expected average of 10 days.

Conditions Module

Conditions

Surgical Procedure, Non-cardiac
Cardiovascular Disease Patients
Perioperative Period

Keywords

Noncardiac surgery;
Perioperative ischemic complications;
Perioperative bleeding complications;
Antithrombotic therapy;
Coronary artery disease;
Stent thrombosis;
Perioperative infarction.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Week

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
University Hospital Patients		Consecutive patients with cardiovascular disease(s) undergoing non-cardiac surgery

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevalence of perioperative complications - especially ischemic or bleeding	Prevalence of perioperative complications - especially ischemic or bleeding; These complications will be correlated with the pattern of antithrombotic therapy administration.	Participants will be followed for the duration of hospital stay, an expected average of 10 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Any kind of non-cardiac surgery (acute or elective) performed under general or neuraxial anaesthesia in four surgical departments - General surgery, Orthopedics-Trauma, Urology and Neurosurgery.
History of cardiovascular disease with risk of arterial, intracardiac or vein thrombosis or embolism. (3) Signed Informed consent.

Exclusion Criteria:

There are no exclusion criteria

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Unselected cohort of consecutive patients undergoing non-cardiac surgery in four surgical clinics of the University Hospital.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Petr Widimsky, Prof.	Cardiocentre, Univ. Hospital Královské Vinohrady, Prague, Czech Rep.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cardiocentre, Univ. Hospital Kralovske Vinohrady		Prague		10034	Czechia
Cardiocentre, Univ. Hospital Královské Vinohrady

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28542316	Derived	Ondrakova M, Motovska Z, Waldauf P, Knot J, Havluj L, Bittner L, Bartoska R, Gurlich R, Krbec M, Dzupa V, Grill R, Widimsky P. Antithrombotic therapy of patients with atrial fibrillation discharged after major non-cardiac surgery. 1-year follow-up. Sub-analysis of PRAGUE 14 study. PLoS One. 2017 May 24;12(5):e0177519. doi: 10.1371/journal.pone.0177519. eCollection 2017.

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases