Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2026-03-05 @ 8:00 PM
Study NCT ID:
NCT01897220
Status:
COMPLETED
Last Update Posted:
2019-02-01
First Post:
2013-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perioperative Ischemia Versus Perioperative Bleeding During Non-cardiac Surgery in Cardiac Patients
Sponsor:
Charles University, Czech Republic
Organization:
Study Overview
Official Title:
Perioperative Ischemia Versus Perioperative Bleeding During Non-cardiac Surgery in Cardiac Patients : PRAGUE 14 Study
Status:
COMPLETED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRAGUE-14
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: