Perioperative Ischemia Versus Perioperative Bleeding During Non-cardiac Surgery in Cardiac Patients (PRAGUE-14)

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, Czech Republic
Information provided by (Responsible Party):
Petr Widimsky, MD, Charles University, Czech Republic
ClinicalTrials.gov Identifier:
NCT01897220
First received: June 27, 2013
Last updated: July 10, 2013
Last verified: July 2013
  Purpose

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.


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

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

Further study details as provided by Charles University, Czech Republic:

Primary Outcome Measures:
  • 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.


Enrollment: 1200
Study Start Date: December 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
University Hospital Patients
Consecutive patients with cardiovascular disease(s) undergoing non-cardiac surgery

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01897220

Locations
Czech Republic
Cardiocentre, Univ. Hospital Kralovske Vinohrady
Prague, Czech Republic, 10034
Cardiocentre, Univ. Hospital Královské Vinohrady
Prague, Czech Republic, 10034
Sponsors and Collaborators
Charles University, Czech Republic
Ministry of Health, Czech Republic
Investigators
Principal Investigator: Petr Widimsky, Prof. Cardiocentre, Univ. Hospital Královské Vinohrady, Prague, Czech Rep.
  More Information

No publications provided

Responsible Party: Petr Widimsky, MD, Professor, Charles University, Czech Republic
ClinicalTrials.gov Identifier: NCT01897220     History of Changes
Other Study ID Numbers: NT/11506-6
Study First Received: June 27, 2013
Last Updated: July 10, 2013
Health Authority: Czech Republic: Ethics Committee

Keywords provided by Charles University, Czech Republic:
Noncardiac surgery;
Perioperative ischemic complications;
Perioperative bleeding complications;
Antithrombotic therapy;
Coronary artery disease;
Stent thrombosis;
Perioperative infarction.

Additional relevant MeSH terms:
Cardiovascular Diseases
Hemorrhage
Ischemia
Pathologic Processes

ClinicalTrials.gov processed this record on July 20, 2014