Patients with cardiovascular risk factors undergoing elective non-cardiac surgery of high or intermediate risk.
Conditions
Interventions
Product Name: Trombyl
Product Code: 11423
Pharmaceutical Form: Tablet
INN or Proposed INN: Acetylsalicylic acid
CAS Number: n/a
Current Sponsor code: n/a
Other descriptive name: n/a
Concentration unit
Sponsors
Professor Christina Eintrei,Institution of Medical & Health, Section of Anesthesiology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with at least one of the following risk factors will be included: · Patients with known or suspected ischemic heart disease · Medical history of congestive heart failure · Renal impairment (S-creatinine > 170 µmol·ml-1). · History of cerebrovascular accident · Insulin treated Diabetes Mellitus. To be included the patient must undergo surgical procedures of high or intermediate risk. In this study patients undergoing the following procedures will be possible to include:· Laparatomier med förväntad operationstid > 1 timme inkluderande: · Esofagus kirurgi · Pancreas kirurgi · Ventrikel kirurgi · Lever kirurgi · Gallvägskirurgi (ej okomplcerade cholecystektomier) · Intraabdominell endokrin kirurgi · Tarm kirurgi · Fundoplicatio/Crusplastik Urologisk kirurgi inkluderande: · Prostata kirurgi, bade open samt transuretral · Nefrektomi · Cystektomi Ortopedisk protes kirurgi, inkluderande: · Höft artroplastik · Knä artroplastik · Axel artroplastik Gynekologisk kirurgi, inkluderande · Abdominell hysterektomi · Transabdominell gynonkologisk kirurgi Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria · Patients undergoing diagnostic procedures · Patients with unstable CAD · Patients with incompensated congestive heart failure · Patients in shock. · Patients with pacemaker. · Patients under 18 years. · Patients with an allergy to aspirin · Patients with a known history of ulcer · Patients on Warfarin or Clopidogrel
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this study is to assess the risks and benefits of continued aspirin therapy in the perioperative period. Two main questions are addressed: 1. What effect do aspirin have in reducing perioperative cardiovascular complications? 2. Is additional bleeding caused by aspirin in the perioperative period? ;Secondary Objective: Study objectives To study the effect of aspirin therapy in a high risk study population regarding: 1. Myocardial cell injury, detected by Troponin T. 2. Myocardial infarction, diagnosed in accordance to the European Society of Cardiology`s and American College of Cardiology`s published guidelines. 3. Thrombotic cerebrovascular accident 4. Long-term outcome, i.e. mortality one year after surgery. 5. Complications, including: a. Incisional hemorrhagic complication b. Gastrointestinal bleeding c. Hemorrhagic cerebrovascular accident d. Spinal/Epidural hematoma 6. Prediction of perioperative myocardial injury and/or poor long-term prognosis by BNP (brain natriuretic peptide), CRP and albumin. ;Primary end point(s): 5. Study outcome 5.1 Primary outcome A. Perioperative myocardial injury B. Perioperative myocardial infarction C. Incidence of haemorrhagic complications. Other outcomes A. One year mortality Cardiac events (myocardial infarction, PCI and/or CABG,) and thrombotic cerebrovascular events within one year after surgery. Correlation between perioperative myocardial injury and preoperative albumin, CRP, BNP and TnT. B. Correlation between postoperative TnT and long-term prognosis. Risk of perioperative myocardial injury related to aspirin treatment compared to placebo. C. Risk of death one year after surgery related to aspirin treatment compared to placebo. | — |
Countries
Sweden
Outcome results
None listed