Surgical Procedure, Non-cardiacPRAGUE-14NCT01897220
Perioperative Ischemia Versus Perioperative Bleeding During Non-cardiac Surgery in Cardiac Patients
An observational study of Surgical Procedure, Non-cardiac and Cardiovascular Disease Patients, run by Charles University, Czech Republic at 2 sites in Czechia.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Surgical Procedure, Non-cardiac, Cardiovascular Disease Patients, Perioperative Period
- How many people
- 1,200 participants
- Where
- 2 sitesCzechia
- Study dates
- Dec 2011to Jun 2013
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Unselected cohort of consecutive patients undergoing non-cardiac surgery in four surgical clinics of the University Hospital.
Who may be able to join
- 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.
Who cannot join
- There are no exclusion criteria
Trial locations and contacts
2 sites in 1 country.
Czechia2 sites
Cardiocentre, Univ. Hospital Kralovske Vinohrady
Prague, 10034
Cardiocentre, Univ. Hospital Královské Vinohrady
Prague, 10034
About this study
Official title: 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.
Read the 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.
- Keywords
- Noncardiac surgery;, Perioperative ischemic complications;, Perioperative bleeding complications;, Antithrombotic therapy;, Coronary artery disease;, Stent thrombosis;, Perioperative infarction.
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| University Hospital Patients | Consecutive patients with cardiovascular disease(s) undergoing non-cardiac surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2013 (estimated)
- Study startDec 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical Procedure, Non-cardiacStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Czech Republic
- Responsible party
- Principal investigator, Petr Widimsky, MD, Charles University, Czech Republic
- Investigators
- Petr Widimsky, Prof., Principal investigator, Cardiocentre, Univ. Hospital Královské Vinohrady, Prague, Czech Rep.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01897220
- Sponsor's protocol ID
- NT/11506-6
- Acronym
- PRAGUE-14
- Status last verified
- Jan 2019
- First submitted
- 27 Jun 2013
- Last updated
- 1 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28542316
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Ischemia Versus Perioperative Bleeding During Non-cardiac Surgery in Cardiac Patients : PRAGUE 14 Study
- ClinicalTrials.gov ID
- NCT01897220
- Acronym / sponsor ID
- PRAGUE-14 / NT/11506-6
- Keywords
- Noncardiac surgery;, Perioperative ischemic complications;, Perioperative bleeding complications;, Antithrombotic therapy;, Coronary artery disease;, Stent thrombosis;, Perioperative infarction.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Collaborators
- Ministry of Health, Czech Republic
- Study start
- Dec 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 11 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| University Hospital Patients | – | –Consecutive patients with cardiovascular disease(s) undergoing non-cardiac surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Unselected cohort of consecutive patients undergoing non-cardiac surgery in four surgical clinics of the University Hospital.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- There are no exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2019.
- Derived from this study: PubMed 28542316Ondrakova 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.
- Main manuscriptLink provided by the sponsor.
- SubanalysisLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petr Widimsky, Prof. principal investigator
Cardiocentre, Univ. Hospital Královské Vinohrady, Prague, Czech Rep.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Procedure, Non-cardiac and Cardiovascular Disease Patients, run by Charles University, Czech Republic at 2 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01897220, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2019.