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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	German Clinical Trials Register
Last refreshed on:	8 April 2024
Main ID:	DRKS00007902
Date of registration:	07/04/2015
Prospective Registration:	Yes
Primary sponsor:	Medizinische Universität Wien
Public title:	Comparison of ROTEM® derived parameters from venous and intraosseous blood
Scientific title:	Comparison of ROTEM® derived parameters from venous and intraosseous blood - ROTEM® i.o.
Date of first enrolment:	01/07/2015
Target sample size:	161
Recruitment status:	Complete
URL:	http://drks.de/search/en/trial/DRKS00007902
Study type:	interventional
Study design:	Allocation: Non-randomized controlled study; Masking: Open (masking not used); Control: Other; Assignment: other; Study design purpose: diagnostic
Phase:	N/A

Countries of recruitment
Austria

Contacts

Name:	Marion Wiegele
Address:	Währinger Gürtel 18-20 1090 Wien Austria
Telephone:	+43-1-40400/68200
Email:	marion.wiegele@meduniwien.ac.at
Affiliation:	AKH Wien Abteilung für Anästhesie, Intensivmedizin und Schmerztherapie

Name:	Marion Wiegele
Address:	Währinger Gürtel 18-20 1090 Wien Austria
Telephone:	+43-1-40400/68200
Email:	marion.wiegele@meduniwien.ac.at
Affiliation:	AKH Wien Abteilung für Anästhesie, Intensivmedizin und Schmerztherapie

Key inclusion & exclusion criteria

Inclusion criteria: Adult, healthy volunteers (male and female) without any known coagulation disorder; written informed consent; patients with polytrauma

Exclusion criteria: • Ingestion of substances* known to influence coagulation tests
• Pregnancy
• breast-feading women
• age < 18à and > 99à

Age minimum: 18 Years
Age maximum: 99 Years
Gender: All

Health Condition(s) or Problem(s) studied

T79.2

healthy probands
T79.2

Traumatic secondary and recurrent haemorrhage

Intervention(s)

Group 1: Part1 of the study: analysis of ROTEM derived parameters from venous and intraosseus blood in healthy subjects

Group 2: Part2 of the study: analysis of ROTEM derived parameters from venous and intraosseus blood in traumatic patients

Primary Outcome(s)

comparability of ROTEM derived Parameters of intravenous and intraosseous blood

Secondary Outcome(s)

Secondary ID(s)

Source(s) of Monetary Support

Medizinische Universität Wien

Österreichische Gesellschaft für Anästhesie, Reanimation und Intensivmedizin (ÖGARI)

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 20/01/2015
Contact:

ethik-kom@meduniwien.ac.at

Ethikkommission der Medizinischen Universität Wien [Ethikkommission der Medizinischen Universität Wien Borschkegasse 8b/6 A-1090 Wien, Austria T +43 1 40 400 – 21470, 22440 F +43 1 40 400 – 16900 ethik-kom@meduniwien.ac.at ethikkommission.meduniwien.ac.at]

+43 1 40 400 – 21470, 22440

ethik-kom@meduniwien.ac.at

Results

Results available:
Date Posted:
Date Completed:	19/08/2018
URL:	http://drks.de/search/en/trial/DRKS00007902#studyResults

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