- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01244425
Fibrin Sealant VH S/D 500 S-apr in Hepatic Resection
A Randomized, Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Fibrin Sealant VH S/D 500 S-apr (Tisseel) for Hemostasis in Subjects Undergoing Hepatic Resection
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
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Berlin, Germany
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Essen, Germany
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Hannover, Germany
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Heidelberg, Germany
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Jena, Germany
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Leipzig, Germany
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Tübingen, Germany
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Pre-Operative Inclusion Criteria:
- Signed informed consent obtained from the subject before any study-related activities
- Subject's age is 18 years or above
- Subject will undergo planned, elective resection of at least 1 anatomical segment of the liver for any reason by laparotomy
- Subject is willing and able to comply with the requirements of the protocol
- Female subjects of childbearing potential must present with a negative serum or urine pregnancy test within 72 hours before the elective liver resection
- Female subjects of childbearing potential must agree to employ adequate birth control measures for the time of their participation in the study
Intra-Operative Inclusion Criteria (before randomization):
- Resection of at least 1 anatomical segment of the liver has been performed
- Oozing from the cut surface of the liver persists after conventional resection procedure and primary control of arterial and venous bleeding by sutures, ligations, clips, vascular stapler, point electrocautery or focal radiofrequency ablation
- Need for additional supportive hemostatic treatment to stop bleeding (i.e. diffuse oozing) of the liver resection area
Pre-Operative Exclusion Criteria:
- Subject needs emergency liver surgery
- Subject will undergo liver resection via laparoscopic procedure
- Subject has known congenital coagulation disorder (e.g. hemophilia)
- Subject has known hypersensitivity to any ingredient of the investigational medicinal product
- Suspected inability or unwillingness of the subject to comply with trial procedures
- If female, subject is pregnant or lactating at the time of study enrollment
- Subject has already participated in this study (each subject can only be enrolled once)
- Subject has participated in another clinical study involving an investigational product or investigational device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving an investigational product or investigational device during the course of this study
Intra-operative Exclusion Criteria (before randomization):
- Occurrence of any severe surgical complication that require resuscitation or deviation from the planned surgical procedure
- Disseminated intravascular coagulopathy (DIC)
- Application of any topical hemostatic material on the resection surface of the liver prior to application of the study treatment
- Radiofrequency precoagulation of the liver resection surface, except focal use of radiofrequency as primary hemostatic treatment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: FS VH S/D 500 s-apr
Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant.
Hemostasis will be assessed at 4, 6, 8 and 10 minutes after application of the study treatment.
|
Dosage form: spray application; dosage frequency: single application
Other Names:
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Active Comparator: Manual compression - Control
A dry surgical gauze swab will be used to apply by hand an even light pressure onto the oozing resection surface of the liver.
Hemostasis will be assessed at 4, 6, 8 and 10 minutes after application of the study treatment.
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Dosage form: surgical gauze swab; dosage frequency: single application
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Intraoperative Hemostasis at 4 Minutes After Treatment Application
Time Frame: 4 minutes post start of treatment application
|
Hemostasis defined as no visible bleeding on the liver resection surface (liver surgical site) after treatment application. Hemostasis had to be maintained until surgical closure. Time recording started with treatment application, ie, with the start of spraying Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) or with the application of manual compression. The following were regarded as treatment failures:
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4 minutes post start of treatment application
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Intraoperative Hemostasis at 6 Minutes After Application of the Randomized Treatment
Time Frame: 6 minutes after start of treatment application
|
Hemostasis defined as no visible bleeding on the liver resection surface (liver surgical site) after treatment application.
Hemostasis had to be maintained until surgical closure.
Time recording started with treatment application, ie, with the start of spraying Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) or with the application of manual compression.
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6 minutes after start of treatment application
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Percentage of Participants With Intraoperative Hemostasis at 8 Minutes After Application of the Randomized Treatment
Time Frame: 8 minutes after start of treatment application
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Hemostasis defined as no visible bleeding on the liver resection surface (liver surgical site) after treatment application.
Hemostasis had to be maintained until surgical closure.
Time recording started with treatment application, ie, with the start of spraying Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) or with the application of manual compression.
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8 minutes after start of treatment application
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Percentage of Participants With Intraoperative Hemostasis at 10 Minutes After Application of the Randomized Treatment
Time Frame: 10 minutes after start of treatment application
|
Hemostasis defined as no visible bleeding on the liver resection surface (liver surgical site) after treatment application.
Hemostasis had to be maintained until surgical closure.
Time recording started with treatment application, ie, with the start of spraying Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) or with the application of manual compression.
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10 minutes after start of treatment application
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Percentage of Participants With Intraoperative Rebleeding After Occurrence of Hemostasis
Time Frame: Intraoperative day 0
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Intraoperative rebleeding from the treated liver resection surface after occurrence of hemostasis.
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Intraoperative day 0
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Percentage of Participants With Postoperative Rebleeding
Time Frame: Postoperative until discharged from surgical ward
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Rebleeding until discharged from the surgical ward, defined as any rebleeding from the treated liver resection surface requiring surgical reexploration
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Postoperative until discharged from surgical ward
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Percentage of Participants With Transfusion Requirements Until Discharged From Surgical Ward
Time Frame: Intra- and postoperative until discharged from surgical ward
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Transfusions administered included whole blood, packed red blood cells, fresh frozen plasma, and thrombocyte concentrate.
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Intra- and postoperative until discharged from surgical ward
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Median Total Volume of Postoperative Drainage Fluid Within 48 Hours After Surgery
Time Frame: Within 48 hours after surgery
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Within 48 hours after surgery
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Baxter BioScience Medical Director, MD, Baxter Healthcare Corporation
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 550904
- 2010-018480-42 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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