Clinical trial NCT02097602: Correlation Between Reticulated Platelets and Major Adverse Cardiac and Cerebrovascular Events After Noncardiac Surgery
Official title: Can Reticulated Platelets Predict the Outcome After Noncardiac Surgery?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Death
Congestive Heart Failure
Angina Pectoris
Stroke
Pulmonary Embolism
Deep Vein Thrombosis
Keywords: Reticulated platelets
noncardiac surgery
MACCEs
major adverse cardiac and cerebrovascular events
outcome
High-risk or intermediate-risk noncardiac surgery
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2014-03-27
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: High-risk or intermediate-risk surgical patients older than 18 years undergoing 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

Eligibility criteria: 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

Primary outcomes:
measure: major adverse cardiac and cerebrovascular events (MACCEs)
timeFrame: during the hospital stay, an expected average of 2 weeks
Secondary outcomes:
measure: Mortality
timeFrame: three months after discharge
measure: length of hospital and intensive care-stay
timeFrame: three months after discharge
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München, Ismaninger Str. 22
Study officials:
affiliation: Klinikum rechts der Isar Technische Universität München
name: Bettina Jungwirth, MD
role: STUDY_DIRECTOR
affiliation: Klinikum rechts der Isar Technische Universität München
name: Aida Anetsberger, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1016/s0049-3848(02)00131-7.
citation: Grove EL, Hvas AM, Kristensen SD. Immature platelets in patients with acute coronary syndromes. Thromb Haemost. 2009 Jan;101(1):151-6.
citation: 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.
citation: Sabate S, Mases A, Guilera N, Canet J, Castillo J, Orrego C, Sabate A, Fita G, Parramon F, Paniagua P, Rodriguez A, Sabate 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.
citation: Anetsberger A, Blobner M, Haller B, Schmid S, Umgelter K, Hager T, Langgartner C, Kochs EF, Laugwitz KL, Jungwirth B, Bernlochner I. Immature platelets as a novel biomarker for adverse cardiovascular events in patients after non-cardiac surgery. Thromb Haemost. 2017 Oct 5;117(10):1887-1895. doi: 10.1160/TH16-10-0804. Epub 2017 Aug 10.