Clinical trial NCT01244425: Fibrin Sealant VH S/D 500 S-apr in Hepatic Resection
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bleeding (Oozing) in Hepatic Resection
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
Collaborators: name: Baxter Innovations GmbH
First posted: 2010-11-19
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare safety and efficacy of Fibrin Sealant (FS) Vapor Heated (VH) S/D 500 s-apr with manual compression as a supportive treatment of local bleeding (i.e. oozing) in hepatic resection surgery when standard surgical techniques are insufficient.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Intraoperative Hemostasis at 4 Minutes After Treatment Application
timeFrame: 4 minutes post start of treatment application
Secondary outcomes:
measure: Percentage of Participants With Intraoperative Hemostasis at 6 Minutes After Application of the Randomized Treatment
timeFrame: 6 minutes after start of treatment application
measure: Percentage of Participants With Intraoperative Hemostasis at 8 Minutes After Application of the Randomized Treatment
timeFrame: 8 minutes after start of treatment application
measure: Percentage of Participants With Intraoperative Hemostasis at 10 Minutes After Application of the Randomized Treatment
timeFrame: 10 minutes after start of treatment application
measure: Percentage of Participants With Intraoperative Rebleeding After Occurrence of Hemostasis
timeFrame: Intraoperative day 0
measure: Percentage of Participants With Postoperative Rebleeding
timeFrame: Postoperative until discharged from surgical ward
measure: Percentage of Participants With Transfusion Requirements Until Discharged From Surgical Ward
timeFrame: Intra- and postoperative until discharged from surgical ward
measure: Median Total Volume of Postoperative Drainage Fluid Within 48 Hours After Surgery
timeFrame: Within 48 hours after surgery
Other outcomes:
Locations:
city: Berlin
country: Germany
city: Essen
country: Germany
city: Hannover
country: Germany
city: Heidelberg
country: Germany
city: Jena
country: Germany
city: Leipzig
country: Germany
city: Tübingen
country: Germany
Study officials:
affiliation: Baxter Healthcare Corporation
name: Baxter BioScience Medical Director, MD
role: STUDY_DIRECTOR
References: