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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01897220
First Posted: July 11, 2013
Last Update Posted: July 11, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ministry of Health, Czech Republic
Information provided by (Responsible Party):
Petr Widimsky, MD, Charles University, Czech Republic
  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

Resource links provided by NLM:


Further study details as provided by Petr Widimsky, MD, 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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Petr Widimsky, MD, Professor, Charles University, Czech Republic
ClinicalTrials.gov Identifier: NCT01897220     History of Changes
Other Study ID Numbers: NT/11506-6
First Submitted: June 27, 2013
First Posted: July 11, 2013
Last Update Posted: July 11, 2013
Last Verified: July 2013

Keywords provided by Petr Widimsky, MD, 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