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

Perioperative Period Clinical Trial

— PRAGUE-14  

Official title:

Perioperative Ischemia Versus Perioperative Bleeding During Non-cardiac Surgery in Cardiac Patients : PRAGUE 14 Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01897220
• Other study ID #: NT/11506-6
• Status: Completed
• Start date: December 2011
• Est. completion date: June 2013

Study information

• Verified date: January 2019
• Source: Charles University, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease Patients
• Cardiovascular Diseases
• Hemorrhage
• Ischemia
• Perioperative Period
• Surgical Procedure, Non-cardiac

Locations

Country	Name	City	State
Czechia	Cardiocentre, Univ. Hospital Kralovske Vinohrady	Prague
Czechia	Cardiocentre, Univ. Hospital Královské Vinohrady	Prague

Sponsors (2)

Lead Sponsor	Collaborator
Charles University, Czech Republic	Ministry of Health, Czech Republic

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Main manuscript
•   Subanalysis