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

Sponsor

Technische Universität München (Other)

Overall Status

Completed

CT.gov ID

NCT02097602

Collaborator

(none)

1,000

Enrollment

Location

Duration (Months)

91.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Death Congestive Heart Failure Angina Pectoris Stroke Pulmonary Embolism Deep Vein Thrombosis

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 Design

Study Type:

Observational

Actual Enrollment :

1000 participants

Time Perspective:

Prospective

Official Title:

Can Reticulated Platelets Predict the Outcome After Noncardiac Surgery?

Study Start Date :

Feb 1, 2014

Actual Primary Completion Date :

Sep 1, 2014

Actual Study Completion Date :

Jan 1, 2015

Outcome Measures

Primary Outcome Measures

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

Mortality [three months after discharge]
mortality
length of hospital and intensive care-stay [three months after discharge]
length of hospital and intensive care-stay

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München, Ismaninger Str. 22	Munich		Germany	81675

Sponsors and Collaborators

Technische Universität München

Investigators

Study Director: Bettina Jungwirth, MD, Klinikum rechts der Isar Technische Universität München
Principal Investigator: Aida Anetsberger, MD, Klinikum rechts der Isar Technische Universität München