The primary objective of the study is to demonstrate the non-inferiority or superiority of Fibrocaps plus gelatin sponge compared to Tachosil when control of mild to moderate bleeding with conventional surgical techniques is ineffective or impractical.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
150
Universitaetsklinik Innsbruck
Innsbruck, Austria
Krankenhaus der Barmherzigen Schwestern Linz Betriebsgesellschaft m.b.H.
Linz, Austria
Medizinische Universitaet Wien AKH
Time to Hemostasis (TTH)
Time frame: Within 5 minutes of treatment
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Vienna, Austria
Universitaetsklinikum Aachen, RWTH
Aachen, Germany
Charite Campus Virchow-Klinikum
Berlin, Germany
Krankenhaus Nordwest GmbH
Frankfurt am Main, Germany
J. W. Goethe Universitaetsklinik Frankfurt
Frankfurt am Main, Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, Germany
Medizinische Hochschule Hannover
Hanover, Germany
Universitätsklinikum Heidelberg
Heidelberg, Germany
...and 5 more locations