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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Greece1 site
  • University Hospital of Ioannina

    Ioannina, 45500

Other trials in Greece

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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  2. 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.

  3. 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).

  4. 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.

  1. First posted23 Feb 2021
  2. Study start8 May 2018
  3. Primary completion8 May 2019
  4. Study completion18 Jul 2019

Resources

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
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

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.

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