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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01897220
Acronym
PRAGUE-14
Enrollment
1200
Registered
2013-07-11
Start date
2011-12-31
Completion date
2013-06-30
Last updated
2019-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease Patients, Perioperative Period, Surgical Procedure, Non-cardiac

Keywords

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

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.

Interventions

None listed

Sponsors

Ministry of Health, Czech Republic
CollaboratorOTHER_GOV
Charles University, Czech Republic
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of perioperative complications - especially ischemic or bleedingParticipants will be followed for the duration of hospital stay, an expected average of 10 daysPrevalence of perioperative complications - especially ischemic or bleeding; These complications will be correlated with the pattern of antithrombotic therapy administration.

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026