ROTEM® Sigma Performance Evaluation - Method Comparison With Predicate Device and Reference Intervals (ROSI-EVA)

ROTEM® sigma is a new thromboelastometric coagulation analysis system. The new system is fully automated allowing for a simple and safe operation compared to its predecessor model ROTEM® delta.

Method comparison of ROTEM® sigma with predecessor model ROTEM® delta) - confirmation of equality.

Confirmation of reference intervals of the ROTEM® systems.

Study Overview

• Status: Unknown
• Conditions: Blood Coagulation Disorders
• Intervention / Treatment: Device: ROTEM sigma

Detailed Description

The main innovation of ROTEM® sigma is the development of a sample handler and a cartridge allowing for a of full automated test operation. As in ROTEM® delta four different tests can be run simultaneously on the four channels of the analyser.

Whereas the tests in ROTEM® delta are performed manually by pipetting a blood sample and liquid system reagents, in ROTEM® sigma the reagents are contained in freeze dried pellet form in a cartridge. Test operation is performed by inserting a cartridge and attaching a blood sample to the analyser.

The five available ROTEM® tests INTEM, EXTEM, FIBTEM, APTEM, and HEPTEM are contained in different combinations in two cartridge configurations:

• Cartridge type 1 including INTEM, EXTEM, FIBTEM, APTEM
• Cartridge type 2 including INTEM, EXTEM, FIBTEM, HEPTEM

Aim of the study is the performance evaluation of the new ROTEM® sigma coagulation analyzer in comparison to the current ROTEM® delta thromboelastometry system.

As a valid method comparison requires test results that cover the whole measurement range of the test system it is also necessary to include acute bleeding and emergency patients in the study. Only the inclusion of acute bleeding and emergency patients will produce strong pathologic test results allowing for a valid evaluation of the test system.

• Study Type: Observational
• Enrollment (Anticipated): 240

Contacts and Locations

• Study Contact: Name: Volker Friemert, Dr.; Phone Number: 11 +49 89 454295; Email: volker-joachim.friemert@tem-innovations.de
• Study Contact Backup: Name: Klaus Görlinger, Dr.; Phone Number: +49 1726596069; Email: klaus.goerlinger@tem-international.de

Study Locations

• Austria
  • Innsbruck, Austria, 6020
    • Recruiting
    • Medi. Medical University Innsbruck Department of General and Surgical Intensive Care Medicine, Medical University Innsbruck
    • Contact: Dietmar Fries, Prof. Dr.; Phone Number: +43 (0)512 504 80455; Email: dietmar.fries@uki.at
    • Principal Investigator: Dietmar Fries, Prof. Dr.
• Switzerland
  • Zurich, Switzerland, 8091
    • Recruiting
    • Institute of Anaesthesiology, Section Anaesthesiology, Intensive Care Medicine and OR-Management University Hospital Zurich
    • Contact: Oliver Theusinger, PD Dr.; Phone Number: +41 (0)44 255 2710; Email: oliver.theusinger@usz.ch
    • Principal Investigator: Oliver Theusinger, PD Dr.
• United States
  • Florida
    • Orlando, Florida, United States, 32789
      • Not yet recruiting
      • Florida Hospital Center for Thrombosis Research
      • Contact: John Francis, MD PhD; Email: john.francis@flhosp.org
      • Principal Investigator: John Francis, MD PhD
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Not yet recruiting
      • University of Maryland Medical Center
      • Contact: Ken Tanaka, MD MSc; Email: ktanaka@anes.umm.edu
      • Principal Investigator: Ken Tanaka, MD MSc
  • New York
    • New York, New York, United States, 10065
      • Not yet recruiting
      • Department of Anesthesiology Weill Cornell Medical College New York-Presbyterian Hospital
      • Contact: Hugh Hemmings, MD PhD; Email: mls9004@med.cornell.edu
      • Principal Investigator: Hugh Hemmings, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

• Patients with expected bleeding and coagulation problems during elective surgery or at the ICU, or trauma patients
• Healthy volunteers

Description

Inclusion Criteria:

Patients:

• Age ≥ 18 years
• Informed written consent
• Patients with an acute bleeding during surgery
• Or: trauma patients with acute bleeding
• Or: hypercoagulable (above normal fibrinogen) patients at the ICU

Healthy Volunteers:

• Adult healthy individuals (≥ 18 years)
• Written informed consent

Exclusion Criteria:

Patients:

• none

Healthy Volunteers:

• Any indications of alcohol or illegal drug abuse
• Any chronic disease with possible effect on the coagulation (liver disease, coronary heart disease)
• Any acute illness within the last 14 days
• Any hemostasis associated disease (myocardial infarction, thrombosis , stroke etc.) within the last year
• Intake of any coagulation affecting medication (aspirin, pain-killers, anti-rheumatic drugs, marcumar, platelet inhibitors) within the last 14 days
• Females only: known pregnancy
• Females only: breast feeding
• Any indication for any hemostasis disorder as interrogated by a specific history of bleeding tendencies

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy Volunteers; Healthy volunteers fulfilling inclusion/exclusion criteria for reference interval sample group are tested with ROTEM sigma	Device: ROTEM sigma; Group Healthy Volunteers: a blood sample is tested with ROTEM sigma Group Patients with expected coagulopathy: a blood sample is tested with ROTEM sigma and ROTEM delta in parallel; Other Names: ROTEM delta
Patients with expected coagulopathy; Patients with expected bleeding and coagulation problems during elective surgery or at the ICU, or trauma patients are tested with ROTEM sigma and ROTEM delta comparatively	Device: ROTEM sigma; Group Healthy Volunteers: a blood sample is tested with ROTEM sigma Group Patients with expected coagulopathy: a blood sample is tested with ROTEM sigma and ROTEM delta in parallel; Other Names: ROTEM delta

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Method comparison: linear regression analysis and bias estimation at medical decision limits	Parameter differences assessed at time of blood sampling

Collaborators and Investigators

• Sponsor: Tem Innovations GmbH
• Investigators: Study Chair: Volker Friemert, Dr., Tem Innovations GmbH

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2017
• Primary Completion (Anticipated): October 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: February 12, 2015
• First Submitted That Met QC Criteria: February 26, 2015
• First Posted (Estimate): March 4, 2015

Study Record Updates

• Last Update Posted (Actual): May 11, 2017
• Last Update Submitted That Met QC Criteria: May 10, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Blood Coagulation Disorders
• Other Study ID Numbers: RSE2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No