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

NCT01244425 | Completed Phase 2 Results

• 2 other identifiers: 5509042010-018480-42
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 7

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.

Conditions

Bleeding (Oozing) in Hepatic Resection

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Intraoperative Hemostasis at 4 Minutes After 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: * 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

  4 minutes post start of treatment application

Secondary Outcomes (7)

• Percentage of Participants With Intraoperative Hemostasis at 6 Minutes After Application of the Randomized Treatment

  6 minutes after start of treatment application

• Percentage of Participants With Intraoperative Hemostasis at 8 Minutes After Application of the Randomized Treatment

  8 minutes after start of treatment application

• Percentage of Participants With Intraoperative Hemostasis at 10 Minutes After Application of the Randomized Treatment

  10 minutes after start of treatment application

• Percentage of Participants With Intraoperative Rebleeding After Occurrence of Hemostasis

  Intraoperative day 0

• Percentage of Participants With Postoperative Rebleeding

  Postoperative until discharged from surgical ward

Study Arms (2)

FS VH S/D 500 s-apr

EXPERIMENTAL

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

Manual compression - Control

ACTIVE COMPARATOR

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

Interventions

Fibrin Sealant (FS) VH S/D 500 s-apr DRUG

Dosage form: spray application; dosage frequency: single application

Also known as: Tisseel

FS VH S/D 500 s-apr

Manual compression OTHER

Dosage form: surgical gauze swab; dosage frequency: single application

Manual compression - Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Baxter Healthcare Corporation: lead
• Baxter Innovations GmbH: collaborator

Study Sites (7)

Unknown Facility

Berlin, Germany

Location

Unknown Facility

Essen, Germany

Location

Unknown Facility

Hanover, Germany

Location

Unknown Facility

Heidelberg, Germany

Location

Unknown Facility

Jena, Germany

Location

Unknown Facility

Leipzig, Germany

Location

Unknown Facility

Tübingen, Germany

Location

MeSH Terms

Conditions

Hemorrhage

Interventions

Fibrin Tissue Adhesive; Low Density Lipoprotein Receptor-Related Protein-1

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fibrin; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; LDL-Receptor Related Proteins; Receptors, LDL; Receptors, Lipoprotein; Receptors, Cell Surface; Membrane Proteins

Results Point of Contact

• Title: Ildiko Szabo, MD, MBA Medical Director, Biosurgery
• Organization: BAXTER INNOVATIONS GmbH

ildiko_szabo@baxter.com

Study Officials

• Baxter BioScience Medical Director, MD

  Baxter Healthcare Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2010
• First Posted: November 19, 2010
• Study Start: November 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: February 20, 2013
• Results First Posted: February 12, 2013

Record last verified: 2013-02

Locations

DE (7)