Antithrombotic Agents ManagementNCT04766606
Management of Anticoagulant Therapy in Non-cardiac Surgery.
An observational study of Antithrombotic Agents Management, run by University of Ioannina at 1 site in Greece.
Trial summary
The perioperative treatment of patients receiving long-term anticoagulant therapy is challenging. This is attributed to the continuation of anticoagulants perioperatively, which is associated with an increased bleeding risk while their discontinuation increases the risk of thromboembolic or ischemic events. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Antithrombotic Agents Management
- How many people
- 614 participants
- Where
- 1 siteGreece
- Study dates
- 8 May 2018to 18 Jul 2019
- How long will I take part?
- 1 Year
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients submmitted for elective non cardiac surgery in University Hospital of Ioannina during one year period.
Who may be able to join
- elective surgery
- non-cardiac surgery
- general, urological, orthopaedic, gynecological, ophthalmological, ENT, plastic surgery and neurosurgery
Who cannot join
- age under 18 years old
- emergency surgery
- mental disorders
- caesarean sections
- surgeries lasting less more than 20 minutes
- patients' refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Management of Anticoagulant Therapy in Non-cardiac Surgical Patients in Relation to Their Postoperative Clinical Outcome.
The perioperative treatment of patients receiving long-term anticoagulant therapy is challenging. This is attributed to the continuation of anticoagulants perioperatively, which is associated with an increased bleeding risk while their discontinuation increases the risk of thromboembolic or ischemic events.
Type of surgery and patient's comorbidities (i.e. haematological diseases, renal or hepatic insufficiency, and concomitant use of other anticoagulants) are significant factors associated with perioperative bleeding. Bleeding risk is stratifies according to the 2011 Canadian Cardiovascular Society Guidelines for the Management of Patients with Antiplatelet Disorder. Surgical thrombotic risk assessment is based on 2014 ESC / ESA Guidelines on non-cardiac surgery.
Read more
The purpose of this study is to investigate and record the management of anticoagulant therapy and long term outcome. The primary target is to record the anticoagulant management in non-cardiac elective surgery during one year in our Hospital. The study involves the investigation of the degree of compliance according to published guidelines. Immediate postoperative complications and major events are secondary goals. Data are assessed at 30, 90 days and one year follow up after surgery.
Understanding the need to discontinue or not antithrombotic agents and adapting treatment strategies according to type of surgery is the key to balance their safety and efficacy. Cardiologists, surgeons, and anaesthesiologists should be aware of the potential catastrophic risks of early discontinuation or continuation of antithrombotic therapy.
Read the detailed description
It is estimated that more than 150,000 patients receive anticoagulant treatment in Greece. More than 10% of those will need to undergo surgery annually. Major side effects of all anticoagulants are bleeding or major thromboembolic events perioperatively.
The perioperative treatment of patients receiving long-term anticoagulant therapy is challenging. This is attributed to the continuation of anticoagulants perioperatively, which is associated with an increased bleeding risk while their discontinuation increases the risk of thromboembolic or ischemic events.
Type of surgery and patient's comorbidities (i.e. haematological diseases, renal or hepatic insufficiency, and concomitant use of other anticoagulants) are significant factors associated with perioperative bleeding. According to the 2011 Canadian Cardiovascular Society Guidelines for the Management of Patients with Antiplatelet Disorder, bleeding risk is stratified as following:
- Very high risk: neurosurgery (intracranial or spinal surgery), cardiac surgery (coronary artery bypass grafting or valve replacement).
- Medium risk: intrathoracic, intra-abdominal procedures, orthopaedic, vascular and other selective procedures (prostate or cervical biopsy).
- High Risk: major vascular surgeries (abdominal aortic aneurysm, aortic bypass), major orthopaedic surgery on the lower extremity (total hip / knee), pneumonectomy, enterectomy, placement of permanent pacemaker or internal defibrillator and other selected procedures (kidney biopsy, pericardium puncture, resection of colon polyps).
- Low risk: laparoscopic procedures (cholecystectomy, inguinal hernia repair), dental, dermatological, ophthalmic procedures, coronary angiography, gastroscopy /colonoscopy and other selected procedures (bone marrow or lymph node biopsy, thoracotomy, joint puncture).
- Very low risk: low risk dental procedures (i.e. tooth extraction), skin biopsy or skin cancer excision, cataract surgery.
Surgical thrombotic risk assessment is based on 2014 ESC / ESA Guidelines on non-cardiac surgery. Low risk (<1%) surgeries include superficial surgery, breast procedures etc., medium risk (1-5%) splenectomy, cholecystectomy, etc., and high risk (>5%) are major aortic and other major blood vessel operations, open limb revascularization or amputation or embolectomy, gastric surgery, hepatectomy, etc.
The purpose of this study is to investigate and record the management of anticoagulant therapy and long term outcome. The primary target is to record the anticoagulant management in non-cardiac elective surgery during one year in our Hospital. The study involves the investigation of the degree of compliance according to published guidelines. Immediate postoperative complications and major events are secondary goals. Data are assessed at 30, 90 days and one year follow up after surgery.
Data recording involves patient demographics, somatometric data, medical history, comorbidities and home medication. Specifically, details concerning antiplatelet or anticoagulant medication, such as diagnosis, duration of treatment, time to treatment discontinuation prior surgery, bridging, intraoperative administration of anticoagulants if needed, time of re-administration postoperatively and what medical specialties were involved in the perioperative management of antithrombotic agents are also included. Hospital length of stay is also recorded. Complications recorded during the one year study period include the following: acute myocardial infarction, pulmonary embolism, vascular haemorrhage, sudden death, arrhythmias, aneurysm rupture, bleeding and management, and other major events. Moreover, after patient discharge, all cause re-hospitalization and any alteration to antithrombotic treatment is also recorded.
Perioperative management of patients receiving antithrombotics is multifactorial and high quality evidence is lacking. The achievement of the delicate balance between efficacy and safety, between thrombotic and hemorrhagic risk, remains a challenge for the physicians who are called upon to treat patients under antithrombotic agents who are candidates for surgery. Understanding the need to discontinue or not antithrombotic agents and adapting treatment strategies according to type of surgery is the key to balance their safety and efficacy. Cardiologists, surgeons, and anaesthesiologists should be aware of the potential catastrophic risks of early discontinuation or continuation of antithrombotic therapy.
- Conditions
- Antithrombotic Agents Management
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioeprative antithrombotic management in elective non-cardiac elective surgery.
Recording of cause of antithrombotic therapy ( ICD-10).
Measured: One weak prior to surgery until one year follow up.
Perioeprative antithrombotic management in elective non-cardiac elective surgery.
Recording of type of preoperative antithrombotic agent (description of treatment).
Measured: One weak prior to surgery until one year follow up.
Perioeprative antithrombotic management in elective non-cardiac elective surgery.
Recording of need of bridging therapy (yes or no).
Measured: Perioperatively (one week before surgery until 30 days after surgery).
Perioeprative antithrombotic management in elective non-cardiac elective surgery.
Recording time of re-administration of antithrombotic therapy postoperatively.
Measured: Postoperatively (until 30 days after surgery).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start8 May 2018
- Primary completion8 May 2019
- Study completion18 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antithrombotic Agents ManagementStudies of the same condition, open and under way.
- 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
- 614 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of Ioannina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BOLOSI MARIA, University of Ioannina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04766606
- Sponsor's protocol ID
- 609a/25-11-2019
- Status last verified
- Feb 2021
- First submitted
- 14 Feb 2021
- Last updated
- 23 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Anticoagulant Therapy in Non-cardiac Surgical Patients in Relation to Their Postoperative Clinical Outcome.
- ClinicalTrials.gov ID
- NCT04766606
- Acronym / sponsor ID
- 609a/25-11-2019
- Conditions
- Antithrombotic Agents Management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 614 participants (actual)
- Lead sponsor
- University of IoanninaUniversity, hospital or other
- Study start
- 8 May 2018 (actual)
- Primary completion
- 8 May 2019 (actual)
- Study completion
- 18 Jul 2019 (actual)
- First posted
- 23 Feb 2021 (actual)
- 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 perioperative treatment of patients receiving long-term anticoagulant therapy is challenging. This is attributed to the continuation of anticoagulants perioperatively, which is associated with an increased bleeding risk while their discontinuation increases the risk of thromboembolic or ischemic events.
Type of surgery and patient's comorbidities (i.e. haematological diseases, renal or hepatic insufficiency, and concomitant use of other anticoagulants) are significant factors associated with perioperative bleeding. Bleeding risk is stratifies according to the 2011 Canadian Cardiovascular Society Guidelines for the Management of Patients with Antiplatelet Disorder. Surgical thrombotic risk assessment is based on 2014 ESC / ESA Guidelines on non-cardiac surgery.
The purpose of this study is to investigate and record the management of anticoagulant therapy and long term outcome. The primary target is to record the anticoagulant management in non-cardiac elective surgery during one year in our Hospital. The study involves the investigation of the degree of compliance according to published guidelines. Immediate postoperative complications and major events are secondary goals. Data are assessed at 30, 90 days and one year follow up after surgery.
Understanding the need to discontinue or not antithrombotic agents and adapting treatment strategies according to type of surgery is the key to balance their safety and efficacy. Cardiologists, surgeons, and anaesthesiologists should be aware of the potential catastrophic risks of early discontinuation or continuation of antithrombotic therapy.
Detailed description
It is estimated that more than 150,000 patients receive anticoagulant treatment in Greece. More than 10% of those will need to undergo surgery annually. Major side effects of all anticoagulants are bleeding or major thromboembolic events perioperatively.
The perioperative treatment of patients receiving long-term anticoagulant therapy is challenging. This is attributed to the continuation of anticoagulants perioperatively, which is associated with an increased bleeding risk while their discontinuation increases the risk of thromboembolic or ischemic events.
Type of surgery and patient's comorbidities (i.e. haematological diseases, renal or hepatic insufficiency, and concomitant use of other anticoagulants) are significant factors associated with perioperative bleeding. According to the 2011 Canadian Cardiovascular Society Guidelines for the Management of Patients with Antiplatelet Disorder, bleeding risk is stratified as following:
- Very high risk: neurosurgery (intracranial or spinal surgery), cardiac surgery (coronary artery bypass grafting or valve replacement).
- Medium risk: intrathoracic, intra-abdominal procedures, orthopaedic, vascular and other selective procedures (prostate or cervical biopsy).
- High Risk: major vascular surgeries (abdominal aortic aneurysm, aortic bypass), major orthopaedic surgery on the lower extremity (total hip / knee), pneumonectomy, enterectomy, placement of permanent pacemaker or internal defibrillator and other selected procedures (kidney biopsy, pericardium puncture, resection of colon polyps).
- Low risk: laparoscopic procedures (cholecystectomy, inguinal hernia repair), dental, dermatological, ophthalmic procedures, coronary angiography, gastroscopy /colonoscopy and other selected procedures (bone marrow or lymph node biopsy, thoracotomy, joint puncture).
- Very low risk: low risk dental procedures (i.e. tooth extraction), skin biopsy or skin cancer excision, cataract surgery.
Surgical thrombotic risk assessment is based on 2014 ESC / ESA Guidelines on non-cardiac surgery. Low risk (<1%) surgeries include superficial surgery, breast procedures etc., medium risk (1-5%) splenectomy, cholecystectomy, etc., and high risk (>5%) are major aortic and other major blood vessel operations, open limb revascularization or amputation or embolectomy, gastric surgery, hepatectomy, etc.
The purpose of this study is to investigate and record the management of anticoagulant therapy and long term outcome. The primary target is to record the anticoagulant management in non-cardiac elective surgery during one year in our Hospital. The study involves the investigation of the degree of compliance according to published guidelines. Immediate postoperative complications and major events are secondary goals. Data are assessed at 30, 90 days and one year follow up after surgery.
Data recording involves patient demographics, somatometric data, medical history, comorbidities and home medication. Specifically, details concerning antiplatelet or anticoagulant medication, such as diagnosis, duration of treatment, time to treatment discontinuation prior surgery, bridging, intraoperative administration of anticoagulants if needed, time of re-administration postoperatively and what medical specialties were involved in the perioperative management of antithrombotic agents are also included. Hospital length of stay is also recorded. Complications recorded during the one year study period include the following: acute myocardial infarction, pulmonary embolism, vascular haemorrhage, sudden death, arrhythmias, aneurysm rupture, bleeding and management, and other major events. Moreover, after patient discharge, all cause re-hospitalization and any alteration to antithrombotic treatment is also recorded.
Perioperative management of patients receiving antithrombotics is multifactorial and high quality evidence is lacking. The achievement of the delicate balance between efficacy and safety, between thrombotic and hemorrhagic risk, remains a challenge for the physicians who are called upon to treat patients under antithrombotic agents who are candidates for surgery. Understanding the need to discontinue or not antithrombotic agents and adapting treatment strategies according to type of surgery is the key to balance their safety and efficacy. Cardiologists, surgeons, and anaesthesiologists should be aware of the potential catastrophic risks of early discontinuation or continuation of antithrombotic therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients submmitted for elective non cardiac surgery in University Hospital of Ioannina during one year period.
Key inclusion criteria (3 listed)
- elective surgery
- non-cardiac surgery
- general, urological, orthopaedic, gynecological, ophthalmological, ENT, plastic surgery and neurosurgery
Key exclusion criteria (6 listed)
- age under 18 years old
- emergency surgery
- mental disorders
- caesarean sections
- surgeries lasting less more than 20 minutes
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
Perioeprative antithrombotic management in elective non-cardiac elective surgery.
Time frame: One weak prior to surgery until one year follow up.
Recording of cause of antithrombotic therapy ( ICD-10).
Perioeprative antithrombotic management in elective non-cardiac elective surgery.
Time frame: One weak prior to surgery until one year follow up.
Recording of type of preoperative antithrombotic agent (description of treatment).
Perioeprative antithrombotic management in elective non-cardiac elective surgery.
Time frame: Perioperatively (one week before surgery until 30 days after surgery).
Recording of need of bridging therapy (yes or no).
Perioeprative antithrombotic management in elective non-cardiac elective surgery.
Time frame: Postoperatively (until 30 days after surgery).
Recording time of re-administration of antithrombotic therapy postoperatively.
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 23 Feb 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antithrombotic Agents Management, run by University of Ioannina at 1 site in Greece.
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 3 inclusion and 6 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 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. 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?
Perioeprative antithrombotic management in elective non-cardiac elective surgery. (time frame: One weak prior to surgery until one year follow up.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2021.