CoagulationNCT00705991
Validation of Thrombelastometry (ROTEM®)
An observational study of Coagulation, run by University of Zurich at 1 site in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coagulation
- What is being tested?
- ROTEM
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2008to Oct 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Healthy Patients
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).
- Patienten / Patientinnen und Probanden / Probandinnen die der Deutschen Sprache nicht mächtig sind.
Trial locations and contacts
1 site in 1 country.
About this study
Das Hauptziele der Studie ist das ROTEM® zu validieren durch die Untersuchung von:
- 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.
- Conditions
- Coagulation
- Being tested
- ROTEM
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROTEMProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2008 (estimated)
- Study startJan 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoagulationStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Donat R Spahn, Prof MD, Principal investigator, University Hospital Zurich, Division of Anaesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00705991
- Sponsor's protocol ID
- StV 27-2007
- Status last verified
- Nov 2012
- First submitted
- 17 Jan 2008
- Last updated
- 23 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Thrombelastometry (ROTEM®)
- ClinicalTrials.gov ID
- NCT00705991
- Acronym / sponsor ID
- StV 27-2007
- Conditions
- Coagulation
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jan 2008
- Study completion
- Oct 2008
- First posted
- 27 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Das Hauptziele der Studie ist das ROTEM® zu validieren durch die Untersuchung von:
- 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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy Patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ROTEM | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donat R Spahn, Prof MD principal investigator
University Hospital Zurich, Division of Anaesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coagulation, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2013.