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

June 27, 2013
July 10, 2013
December 2011
June 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01897220 on ClinicalTrials.gov Archive Site
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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

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.

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.

Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
1 Week
Not Provided
Probability Sample

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

  • Surgical Procedure, Non-cardiac
  • Cardiovascular Disease Patients
  • Perioperative Period
Not Provided
University Hospital Patients
Consecutive patients with cardiovascular disease(s) undergoing non-cardiac surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1200
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic
 
NCT01897220
NT/11506-6
No
Petr Widimsky, MD, Charles University, Czech Republic
Charles University, Czech Republic
Ministry of Health, Czech Republic
Principal Investigator: Petr Widimsky, Prof. Cardiocentre, Univ. Hospital Královské Vinohrady, Prague, Czech Rep.
Charles University, Czech Republic
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP