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

Stroke Clinical Trial

Official title:

Can Reticulated Platelets Predict the Outcome After Noncardiac Surgery?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02097602
• Other study ID #: RePOS
• Status: Completed
• Phase: N/A
• First received: March 17, 2014
• Last updated: March 4, 2015
• Start date: February 2014
• Est. completion date: January 2015

Study information

• Verified date: March 2015
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: January 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Germany	Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München, Ismaninger Str. 22	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

References & Publications (4)

Cesari F, Marcucci R, Gori AM, Caporale R, Fanelli A, Casola G, Balzi D, Barchielli A, Valente S, Giglioli C, Gensini GF, Abbate R. Reticulated platelets predict cardiovascular death in acute coronary syndrome patients. Insights from the AMI-Florence 2 Study. Thromb Haemost. 2013 May;109(5):846-53. doi: 10.1160/TH12-09-0709. Epub 2013 Mar 14. — View Citation

Grove EL, Hvas AM, Kristensen SD. Immature platelets in patients with acute coronary syndromes. Thromb Haemost. 2009 Jan;101(1):151-6. — View Citation

Nakamura T, Uchiyama S, Yamazaki M, Okubo K, Takakuwa Y, Iwata M. Flow cytometric analysis of reticulated platelets in patients with ischemic stroke. Thromb Res. 2002 May 15;106(4-5):171-7. — View Citation

Sabaté S, Mases A, Guilera N, Canet J, Castillo J, Orrego C, Sabaté A, Fita G, Parramón F, Paniagua P, Rodríguez A, Sabaté M; ANESCARDIOCAT Group. Incidence and predictors of major perioperative adverse cardiac and cerebrovascular events in non-cardiac surgery. Br J Anaesth. 2011 Dec;107(6):879-90. doi: 10.1093/bja/aer268. Epub 2011 Sep 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Mortality	mortality	three months after discharge	No
Secondary	length of hospital and intensive care-stay	length of hospital and intensive care-stay	three months after discharge	No