Validation of Thrombelastometry (ROTEM®)

January 22, 2013 updated by: University of Zurich

Das Hauptziele der Studie ist das ROTEM® zu validieren durch die Untersuchung von:

i) Reproduzierbarkeit von ROTEM® ii) Präzision der ROTEM®-Tests, sowie iii) der Zeitspanne, während derer die Ergebnisse in Zitrat-Blut reproduzierbar sind

Die durchzuführenden Tests sind FIBTEM, EXTEM, INTEM in ROTEM® um die Funktion der Thrombozyten während der Lagerungszeit zu untersuchen.

Nur Zitrat-Blut wird den Patienten abgenommen, die Reklazifikation findet kurz vor der Durchführen der Tests stattfinden, um so nahe wie möglich an der klinischen Praxis zu sein.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

Healthy Patients

Description

Inclusion criteria: 1. Vorgesehen für einen elektiven Eingriff 2. Unterschriebene Einverständniserklärung

Exclusion criteria: 1. bekannte Tumorerkrankung oder Immunosupression, 2. bekannte Gerinnungsstörung 3. Antikoagulation 4. Behandlung mit Heparin über 3000 UI im Sinne der Thrombose-Prophylaxe hinaus 5. Gebrauch von Acetylsalicylsäure innerhalb der letzten 5 Tage 6. Gebrauch von NSRA innerhalb der letzten 24 Stunden 7. bekannte Niereninsuffizienz oder eine Plasmakonzentration von Kreatinin grösser 120 Mm, oder Lebererkrankungen oder einer Plasmakonzentration von ASAT (> 50 U/l) oder ALAT (> 50 U/l).

8. Patienten / Patientinnen und Probanden / Probandinnen die der Deutschen Sprache nicht mächtig sind.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

  • Principal Investigator: Donat R Spahn, Prof MD, University Hospital Zurich, Division of Anaesthesiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion

December 7, 2022

Study Completion

October 1, 2008

Study Registration Dates

First Submitted

January 17, 2008

First Submitted That Met QC Criteria

June 26, 2008

First Posted (Estimate)

June 27, 2008

Study Record Updates

Last Update Posted (Estimate)

January 23, 2013

Last Update Submitted That Met QC Criteria

January 22, 2013

Last Verified

November 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • StV 27-2007

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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