Low-dose Acetylsalicylic Acid Before Non-cardiac Surgery

Surgery Clinical Trial

Official title:

Discontinuation of Low-dose Acetylsalicylic Acid Before Elective Non-cardiac Surgery: a Preoperative Monocentric Cross-sectional Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03049566
• Other study ID #: WF03013
• Status: Completed
• Phase: N/A
• First received: February 8, 2017
• Last updated: March 6, 2017
• Start date: February 10, 2014
• Est. completion date: December 30, 2014

Study information

• Verified date: March 2017
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 805
• Est. completion date: December 30, 2014
• Est. primary completion date: December 30, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Platelet Dysfunction
• Surgery

Intervention

Other:
• preoperative questionnaires
no intervention, cross-sectional survey in a single group

Locations

Country	Name	City	State
Germany	Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preoperative discontinuation of acetylsalicylic acid medication	questionnaires (cross-sectional observation during preoperative assessment)	1 day