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

Can Reticulated Platelets Predict the Outcome After Noncardiac Surgery?

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02097602

Enrollment

1000

Registered

2014-03-27

Start date

2014-02-28

Completion date

2015-01-31

Last updated

2015-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Reticulated platelets, noncardiac surgery, MACCEs, major adverse cardiac and cerebrovascular events, outcome, High-risk or intermediate-risk noncardiac surgery

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

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Germany

Outcome results