Correlation Between Reticulated Platelets and Major Adverse Cardiac and Cerebrovascular Events After Noncardiac Surgery

Study Overview
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Brief Summary
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This is an observational study designed to monitor the course of the fraction of reticulated platelets and the correlation thereof to major adverse cardiac and cerebrovascular events after noncardiac surgery.

Detailed Description
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Reticulated platelets (RP) are newly formed, immature platelets which in contrast to mature platelets have high granule content and a residual amount of mRNA. An increased mean platelet volume (MPV) and the fraction of RP have been shown to be correlated to cardiovascular events like myocardial infarction or cardiovascular death. However, there are no trials so far investigating how surgery impacts the fraction of RP and how this fraction correlates with the outcome after noncardiac surgery. Patients with an age above 18 years undergoing high-risk or intermediate-risk noncardiac surgery are to be included. The fraction of RP is to be investigated in routinely acquired blood samples preoperatively, postoperatively in the recovery room, as well as 24-72 hours after anaesthesia and surgery. A primary common endpoint are major adverse cardiac and cerebrovascular events (MACCEs), as well as deep vein thrombosis and pulmonary embolism. MACCEs are defined according to Sabaté et al. as: cardiac death, cerebrovascular death, nonfatal cardiac arrest, acute myocardial infarction, congestive heart failure, new cardiac arrhythmia, angina or stroke. Secondary endpoints are lengths of hospital stay and intensive care stay as well as mortality after 3 months. All participants are to be contacted by phone three months after discharge and their health situation is to be determined. 1000 patients will be enrolled in a defined time frame of six months

Official Title
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Can Reticulated Platelets Predict the Outcome After Noncardiac Surgery?

Conditions
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Angina Pectoris, Cardiac Death, Congestive Heart Failure, Stroke, Pulmonary Embolism, Deep Vein Thrombosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: high-risk or intermediate-risk surgical patients undergoing noncardiac surgery age ≥ 18 years written informed consent Exclusion Criteria: low-risk surgery age < 18 years

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| major adverse cardiac and cerebrovascular events (MACCEs) | MACCEs are defined according to Sabaté et al. as: cardiac death, cerebrovascular death, nonfatal cardiac arrest, acute myocardial infarction, congestive heart failure, new cardiac arrhythmia, angina or stroke. Pulmonary embolism and deep vein thrombosis are further primary endpoints. | during the hospital stay, an expected average of 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | mortality | three months after discharge | 
| length of hospital and intensive care-stay | length of hospital and intensive care-stay | three months after discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Reticulated platelets, noncardiac surgery, MACCEs, major adverse cardiac and cerebrovascular events, outcome, High-risk or intermediate-risk noncardiac surgery