Clinical trial NCT03049566: Low-dose Acetylsalicylic Acid Before Non-cardiac Surgery
Official title: Discontinuation of Low-dose Acetylsalicylic Acid Before Elective Non-cardiac Surgery: a Preoperative Monocentric Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Platelet Dysfunction
Keywords: Bleeding
Adverse Cardiac Events
Adherence, Medication
Aspirin
Acetylsalicylic acid
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2017-02-10
Enrollment: 805
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for elective non-cardiac surgery, who present in the pre-assessment clinic of the University Medical Center Hamburg-Eppendorf during the study recruitment period, are screened for eligibility.

Brief summary: This study aims to assess independent factors associated with the clinical decision to discontinue ASA preoperatively in patients undergoing elective non-cardiac surgery.

Detailed description: Acetylsalicylic acid (ASA) is widely used for primary and secondary prevention of cardiovascular diseases. A prothrombotic rebound phenomenon after aspirin cessation has been reported. ASA withdrawal is associated with an increased incidence of adverse cardiac events. In individuals with previous percutaneous coronary intervention (PCI), cessation of ASA may cause stent thrombosis or myocardial infarction. However, many patients undergo non-cardiac surgery within the first two years after PCI. Perioperatively, two counteracting risks have to be taken into account, first, the risk of thromboembolic complications, if ASA medication is discontinued and second, the risk of surgical bleeding, if ASA therapy is continued. However, factors contributing to preoperative decision-making for ASA-withdrawal are still unclear.

This study aims to assess independent factors associated with the clinical decision to discontinue ASA preoperatively in patients undergoing elective non-cardiac surgery. In particular this study aims to determine if the presence of coronary stents is independently associated with ASA discontinuation. Furthermore this study assesses, if benefit-risk-estimates (numerical rating scales) of the patients and the supervising physicians are associated with the decision to withdraw ASA.

Study design

Patients on long-term ASA undergoing non-cardiac surgery as well as their supervising anesthesiologist participate in a preoperative survey. Detailed information about ASA medication, perioperative ASA use, comorbidities, factors that might be associated with the decision to discontinue ASA preoperatively and benefit-risk-estimates (numerical rating scales) are sampled by questionnaires.

Eligibility criteria: Inclusion Criteria:

* 18 Years and older
* Scheduled for elective non-cardiac surgery
* Regular long-term ASA use, defined as daily low-dose (≤100mg) ASA therapy, even if ASA-medication was interrupted within the last 30 days before study inclusion

Exclusion Criteria:

* \< 18 Years
* No consent given

Primary outcomes:
measure: Preoperative discontinuation of acetylsalicylic acid medication
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf
Study officials:
affiliation: Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf
name: Christian Zöllner, Professor
role: STUDY_DIRECTOR
affiliation: Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf
name: Martin Petzoldt, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: