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

Completed

Phase N/A Results N/A

Trial Description

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

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

Conditions

Trial Design

  • Perspective: Prospective
  • Sampling: Non-Probability Sample

Trial Population

High-risk or intermediate-risk surgical patients older than 18 years undergoing noncardiac surgery

Outcomes

Type Measure Time Frame Safety Issue
Primary major adverse cardiac and cerebrovascular events (MACCEs) during the hospital stay, an expected average of 2 weeks No
Secondary Mortality three months after discharge No
Secondary length of hospital and intensive care-stay three months after discharge No

Sponsors