Validation of Thrombelastometry (ROTEM®)

This study is currently recruiting participants.

Verified by University of Zurich, June 2008

First Received: January 17, 2008 Last Updated: June 26, 2008 History of Changes

Sponsored by:	University of Zurich
Information provided by:	University of Zurich
ClinicalTrials.gov Identifier:	NCT00705991

Purpose

The study's main objectives are to validate ROTEM® by investigating

the reproducibility of ROTEM®,
the precision of ROTEM® test, as well as
time period during which reproducible results can be obtained in citrated blood.

The tests to be performed are FIBTEM, EXTEM, INTEM in ROTEM® will be performed to investigate the function of platelet during storage time.

Only citrated blood will be withdrawn from patients and re-calcification will take place before performing the tests, to be as close as possible to the clinical practice.

Condition	Intervention	Phase
Coagulation	Procedure: ROTEM	Phase IV

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	Validation of Thrombelastometry (ROTEM®)

Further study details as provided by University of Zurich:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	58
Study Start Date:	January 2008
Estimated Study Completion Date:	October 2008

Intervention Details:

Blood to be taken from patient - intervention is phlebotomy

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients with no particular health problem, ASA I or II, no coagulopathies

Criteria

Inclusion criteria

Scheduled for a non-emergent operation
Signed written informed consent

Exclusion criteria

Known malignancy or immunosuppression,
Known coagulation disorders,
Anticoagulation
Current treatment with heparin (other than routine preoperative thromboembolic prophylaxis (see below)
Use of acetyl salicylic acid within the past 5 days,
Use of nonsteroidal antiinflammatory agents within the past 24 h,
Known renal diseases, or plasma concentration of creatinine more than 120 mM, and liver diseases or increased plasma concentration of aspartate aminotransferase (> 50 U/l) or alanine aminotransferase (> 50 U/l).
Patients not capable of understanding the German language

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00705991

Contacts

Contact: 01 Studienregister MasterAdmins

+41 (0)44 255 11 11

Locations

Switzerland
Univeristätsspital	Recruiting
Zurich, Switzerland
Contact: Oliver M Theusinger, MD, Dr. +41442551111
Principal Investigator: Oliver M Theusinger, MD Dr.

Sponsors and Collaborators

University of Zurich

Investigators

Study Director:

01 Studienregister MasterAdmins

UniversitaetsSpital Zuerich

More Information

No publications provided

Responsible Party:	Univerity Hospital Zurich ( M. Theusinger )
Study ID Numbers:	StV 27-2007
Study First Received:	January 17, 2008
Last Updated:	June 26, 2008
ClinicalTrials.gov Identifier:	NCT00705991 History of Changes
Health Authority:	Switzerland: Swissmedic

ClinicalTrials.gov processed this record on May 06, 2009