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

Completed

• Conditions: Cardiac Death; Stroke; Pulmonary Embolism; Deep Vein Thrombosis; Congestive Heart Failure; Angina Pectoris

• Registration Number: NCT02097602
• Lead Sponsor: Technical University of Munich

Brief Summary

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

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-03-17
• Study First Submitted QC: 2014-03-24
• Study First Posted: 2014-03-27
• Primary Completion: 2014-09
• Study Completion: 2015-01
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-04
• Last Update Posted: 2015-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
major adverse cardiac and cerebrovascular events (MACCEs)	during the hospital stay, an expected average of 2 weeks	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.

Secondary Outcome Measures

Name	Time	Method
length of hospital and intensive care-stay	three months after discharge	length of hospital and intensive care-stay
Mortality	three months after discharge	mortality

Trial Locations

Locations (1)

Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München, Ismaninger Str. 22; 🇩🇪 Munich, Germany