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

NCT01897220 | Completed

• 1 other identifier: NT/11506-6
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 2

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.

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.

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

University Hospital Patients

Consecutive patients with cardiovascular disease(s) undergoing non-cardiac surgery

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Unselected cohort of consecutive patients undergoing non-cardiac surgery in four surgical clinics of the University Hospital.

You may qualify if:

• 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.

Sponsors & Collaborators

• Charles University, Czech Republic: lead
• Ministry of Health, Czech Republic: collaborator

Study Sites (2)

Cardiocentre, Univ. Hospital Kralovske Vinohrady

Prague, 10034, Czechia

Location

Cardiocentre, Univ. Hospital Královské Vinohrady

Prague, 10034, Czechia

Location

Related Publications (1)

• 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.

  PMID: 28542316 DERIVED

Related Links

• Main manuscript
• Subanalysis

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Petr Widimsky, Prof.

  Cardiocentre, Univ. Hospital Královské Vinohrady, Prague, Czech Rep.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 27, 2013
• First Posted: July 11, 2013
• Study Start: December 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: February 1, 2019

Record last verified: 2019-01

Locations

CZ (2)