Perioperative Ischemia Versus Perioperative Bleeding During Non-cardiac Surgery in Cardiac Patients (PRAGUE-14)
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.
Surgical Procedure, Non-cardiac
Cardiovascular Disease Patients
|Study Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration:||1 Week|
|Official Title:||Perioperative Ischemia Versus Perioperative Bleeding During Non-cardiac Surgery in Cardiac Patients : PRAGUE 14 Study|
- Prevalence of perioperative complications - especially ischemic or bleeding [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 10 days ] [ Designated as safety issue: No ]Prevalence of perioperative complications - especially ischemic or bleeding; These complications will be correlated with the pattern of antithrombotic therapy administration.
|Study Start Date:||December 2011|
|Study Completion Date:||June 2013|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
University Hospital Patients
Consecutive patients with cardiovascular disease(s) undergoing non-cardiac surgery
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01897220
|Cardiocentre, Univ. Hospital Kralovske Vinohrady|
|Prague, Czech Republic, 10034|
|Cardiocentre, Univ. Hospital Královské Vinohrady|
|Prague, Czech Republic, 10034|
|Principal Investigator:||Petr Widimsky, Prof.||Cardiocentre, Univ. Hospital Královské Vinohrady, Prague, Czech Rep.|