Clinical trial NCT01897220: Perioperative Ischemia Versus Perioperative Bleeding During Non-cardiac Surgery in Cardiac Patients
Official title: Perioperative Ischemia Versus Perioperative Bleeding During Non-cardiac Surgery in Cardiac Patients : PRAGUE 14 Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
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.
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Czech Republic
First posted: 2013-07-11
Enrollment: 1200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Unselected cohort of consecutive patients undergoing non-cardiac surgery in four surgical clinics of the University Hospital.

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.

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

Primary outcomes:
measure: Prevalence of perioperative complications - especially ischemic or bleeding
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Cardiocentre, Univ. Hospital Kralovske Vinohrady
city: Prague
country: Czechia
facility: Cardiocentre, Univ. Hospital Královské Vinohrady
Study officials:
affiliation: Cardiocentre, Univ. Hospital Královské Vinohrady, Prague, Czech Rep.
name: Petr Widimsky, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.