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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00705991
Other study ID # StV 27-2007
Secondary ID
Status Completed
Phase Phase 4
First received January 17, 2008
Last updated January 22, 2013
Start date January 2008
Est. completion date October 2008

Study information

Verified date November 2012
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority Switzerland: UZurich
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date October 2008
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Procedure:
ROTEM


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

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