Low-dose Acetylsalicylic Acid Before Non-cardiac Surgery

Completed

• Conditions: Surgery; Platelet Dysfunction
• Interventions: Other: preoperative questionnaires

• Registration Number: NCT03049566
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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.

Study Timeline

• Study Start: 2014-02-10
• Primary Completion: 2014-12-30
• Study Completion: 2014-12-30
• Study First Submitted: 2017-02-08
• Study First Submitted QC: 2017-02-09
• Study First Posted: 2017-02-10
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-06
• Last Update Posted: 2017-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 805

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
preoperative questionnaires	preoperative questionnaires	Patients on long-term acetylsalicylic acid undergoing non-cardiac surgery

Primary Outcome Measures

Name	Time	Method
Preoperative discontinuation of acetylsalicylic acid medication	1 day	questionnaires (cross-sectional observation during preoperative assessment)

Trial Locations

Locations (1)

Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany