NCT03049566

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
805

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2014

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 8, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 10, 2017

Completed
Last Updated

March 8, 2017

Status Verified

March 1, 2017

Enrollment Period

11 months

First QC Date

February 8, 2017

Last Update Submit

March 6, 2017

Conditions

SurgeryPlatelet Dysfunction

Keywords

BleedingAdverse Cardiac EventsAdherence, MedicationAspirinAcetylsalicylic acid

Outcome Measures

Primary Outcomes (1)

  • Preoperative discontinuation of acetylsalicylic acid medication

    questionnaires (cross-sectional observation during preoperative assessment)

    1 day

Study Arms (1)

preoperative questionnaires

Patients on long-term acetylsalicylic acid undergoing non-cardiac surgery

Other: preoperative questionnaires

Interventions

preoperative questionnairesOTHER

no intervention, cross-sectional survey in a single group

preoperative questionnaires

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Years and older
  • Scheduled for elective non-cardiac surgery

You may not qualify if:

  • \< 18 Years
  • No consent given

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf

Hamburg, Hamburg, 20246, Germany

Location

MeSH Terms

Conditions

HemorrhageCardiovascular DiseasesMedication Adherence

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Christian Zöllner, Professor

    Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf

    STUDY DIRECTOR

  • Martin Petzoldt, Dr. med.

    Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2017

First Posted

February 10, 2017

Study Start

February 10, 2014

Primary Completion

December 30, 2014

Study Completion

December 30, 2014

Last Updated

March 8, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)