Fibrin Sealant VH S/D 500 S-apr in Hepatic Resection

This study has been completed.
Sponsor:
Collaborator:
Baxter Innovations GmbH
Information provided by (Responsible Party):
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT01244425
First received: November 18, 2010
Last updated: February 19, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Bleeding (Oozing) in Hepatic Resection
Drug: Fibrin Sealant (FS) VH S/D 500 s-apr
Other: Manual compression
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:
  • Percentage of Participants With Intraoperative Hemostasis at 4 Minutes After Treatment Application [ Time Frame: 4 minutes post start of treatment application ] [ Designated as safety issue: No ]

    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:

    • No hemostasis achieved at 4 minutes post treatment application (for the FS VH S/D 500 s-apr arm, the "time to hemostasis" was used; a time window of +5 seconds was acceptable for showing a success)
    • Additional hemostatic treatment (ie, hemostatics in addition to the randomized treatment) was required
    • Reapplication of FS VH S/D 500 s-apr after 4 minutes
    • Intraoperative rebleeding after the first 4 minutes of the observation period


Secondary Outcome Measures:
  • Percentage of Participants With Intraoperative Hemostasis at 6 Minutes After Application of the Randomized Treatment [ Time Frame: 6 minutes after start of treatment application ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Intraoperative Hemostasis at 8 Minutes After Application of the Randomized Treatment [ Time Frame: 8 minutes after start of treatment application ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Intraoperative Hemostasis at 10 Minutes After Application of the Randomized Treatment [ Time Frame: 10 minutes after start of treatment application ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Intraoperative Rebleeding After Occurrence of Hemostasis [ Time Frame: Intraoperative day 0 ] [ Designated as safety issue: No ]
    Intraoperative rebleeding from the treated liver resection surface after occurrence of hemostasis.

  • Percentage of Participants With Postoperative Rebleeding [ Time Frame: Postoperative until discharged from surgical ward ] [ Designated as safety issue: No ]
    Rebleeding until discharged from the surgical ward, defined as any rebleeding from the treated liver resection surface requiring surgical reexploration

  • Percentage of Participants With Transfusion Requirements Until Discharged From Surgical Ward [ Time Frame: Intra- and postoperative until discharged from surgical ward ] [ Designated as safety issue: No ]
    Transfusions administered included whole blood, packed red blood cells, fresh frozen plasma, and thrombocyte concentrate.

  • Median Total Volume of Postoperative Drainage Fluid Within 48 Hours After Surgery [ Time Frame: Within 48 hours after surgery ] [ Designated as safety issue: No ]

Enrollment: 70
Study Start Date: November 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Fibrin Sealant (FS) VH S/D 500 s-apr
Dosage form: spray application; dosage frequency: single application
Other Name: Tisseel
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.
Other: Manual compression
Dosage form: surgical gauze swab; dosage frequency: single application

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01244425

Locations
Germany
Berlin, Germany
Essen, Germany
Hannover, Germany
Heidelberg, Germany
Jena, Germany
Leipzig, Germany
Tübingen, Germany
Sponsors and Collaborators
Baxter Healthcare Corporation
Baxter Innovations GmbH
Investigators
Study Director: Baxter BioScience Medical Director, MD Baxter Healthcare Corporation
  More Information

No publications provided

Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT01244425     History of Changes
Other Study ID Numbers: 550904, 2010-018480-42
Study First Received: November 18, 2010
Results First Received: January 9, 2013
Last Updated: February 19, 2013
Health Authority: Germany: Paul-Ehrlich-Institut

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
Fibrin Tissue Adhesive
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014