NCT02379104

Brief Summary

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2017

Geographic Reach
3 countries

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 4, 2015

Completed
2.6 years until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

May 11, 2017

Status Verified

May 1, 2017

Enrollment Period

1 year

First QC Date

February 12, 2015

Last Update Submit

May 10, 2017

Conditions

Blood Coagulation Disorders

Outcome Measures

Primary Outcomes (1)

  • Method comparison: linear regression analysis and bias estimation at medical decision limits

    Parameter differences assessed at time of blood sampling

Study Arms (2)

Healthy Volunteers

Healthy volunteers fulfilling inclusion/exclusion criteria for reference interval sample group are tested with ROTEM sigma

Device: ROTEM sigma

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

Interventions

ROTEM sigmaDEVICE

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

Also known as: ROTEM delta
Healthy VolunteersPatients with expected coagulopathy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Florida Hospital Center for Thrombosis Research

Orlando, Florida, 32789, United States

NOT YET RECRUITING

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

NOT YET RECRUITING

Department of Anesthesiology Weill Cornell Medical College New York-Presbyterian Hospital

New York, New York, 10065, United States

NOT YET RECRUITING

Medi. Medical University Innsbruck Department of General and Surgical Intensive Care Medicine, Medical University Innsbruck

Innsbruck, 6020, Austria

RECRUITING

Institute of Anaesthesiology, Section Anaesthesiology, Intensive Care Medicine and OR-Management University Hospital Zurich

Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Blood Coagulation Disorders

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Volker Friemert, Dr.

    Tem Innovations GmbH

    STUDY CHAIR

Central Study Contacts

Volker Friemert, Dr.

CONTACT

+49 89 454295volker-joachim.friemert@tem-innovations.de

Klaus Görlinger, Dr.

CONTACT

+49 1726596069klaus.goerlinger@tem-international.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2015

First Posted

March 4, 2015

Study Start

October 1, 2017

Primary Completion

October 1, 2018

Study Completion

December 1, 2018

Last Updated

May 11, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)AU(1)US(3)