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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-000816-32 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fibrocaps | Experimental | Human fibrinogen and thrombin powder. Single application during surgery Other Names:
Device: Gelatin sponge. Single application during surgery Other Name: Spongostan |
|
| TachoSil | Active Comparator | Human fibrinogen and thrombin powder. Single application during surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fibrocaps | Drug |
|
| |
| TachoSil |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Hemostasis (TTH) | Within 5 minutes of treatment |
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Inclusion Criteria (pre-surgery):
Subject has signed an independent ethics committee (IEC)-approved informed consent document
Subject is undergoing hepatic wedge resection or anatomic resection of 1 to 5 contiguous hepatic segments, and/or other hepatic surgery, any of which may be combined with other surgical procedures involving the gall bladder or intestines
Subject age is >18 years at time of consent
If female and of child-bearing potential, subject has negative pregnancy test during screening and is not breast-feeding
If subject is a sexually active male or a sexually active female of child-bearing potential, subject agrees to use a medically accepted form of contraception from the time of consent to completion of all follow-up study visits
Inclusion Criteria (during surgery):
Presence of mild to moderate bleeding/oozing when control by conventional surgical techniques, including but not limited to suture, ligature and cautery is ineffective or impractical
Absence of intra-operative complications other than bleeding which, in the opinion of the investigator, may interfere with the assessment of efficacy or safety
Approximate TBS surface area of ≤ 100 cm^2
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wolf Bechstein, MD | J.W.Goethe-Universität | Principal Investigator |
| Martin Bodingbauer, MD | Medical University of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitaetsklinik Innsbruck | Innsbruck | A-6020 | Austria | |||
| Krankenhaus der Barmherzigen Schwestern Linz Betriebsgesellschaft m.b.H. |
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| ID | Term |
|---|---|
| D015718 | Fibrin Tissue Adhesive |
| C518955 | TachoSil |
| ID | Term |
|---|---|
| D005337 | Fibrin |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Drug |
|
| Linz |
| A-4010 |
| Austria |
| Medizinische Universitaet Wien AKH | Vienna | A-1090 | Austria |
| Universitaetsklinikum Aachen, RWTH | Aachen | 52074 | Germany |
| Charite Campus Virchow-Klinikum | Berlin | 13353 | Germany |
| Krankenhaus Nordwest GmbH | Frankfurt am Main | D-60488 | Germany |
| J. W. Goethe Universitaetsklinik Frankfurt | Frankfurt am Main | D-60590 | Germany |
| Universitaetsklinikum Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Universitätsklinikum Heidelberg | Heidelberg | 69120 | Germany |
| Universitaetsklinikum Leipzig AoeR | Leipzig | 04103 | Germany |
| Klinikum Rechts der Isar Munich | Munich | Germany |
| Klinikum der LMU Muenchen - Campus Grosshadern | München | 81377 | Germany |
| Klinikum Stuttgart - Katharinenhospital (KH) | Stuttgart | Germany |
| Universitaetsklinikum Tuebingen | Tübingen | 72976 | Germany |