Fibrin Sealant VH S/D 500 S-apr in Hepatic Resection | NCT01244425

NCT01244425

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
2010-018480-42	EudraCT Number

Status Module

Name	Class
Baxter Innovations GmbH	INDUSTRY

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Fibrin Sealant (FS) VH S/D 500 s-apr	Drug	Dosage form: spray application; dosage frequency: single application	FS VH S/D 500 s-apr

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Percentage of Participants With Intraoperative Hemostasis at 6 Minutes After Application of the Randomized Treatment	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.

Eligibility Module

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

Name	Affiliation	Role
Baxter BioScience Medical Director, MD	Baxter Healthcare Corporation	Study Director

Arm/Group Information

ID	Title	Description
FG000	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.
FG001	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.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	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.
BG001

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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

full analysis (data) set (FAS)

Posted

Number

95% Confidence Interval

percentage of participants

4 minutes post start of treatment application

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.

Facility	Status	City	State	ZIP	Country	Contacts
		Berlin			Germany

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D015718	Fibrin Tissue Adhesive
D026503	Low Density Lipoprotein Receptor-Related Protein-1

ID	Term
D005337	Fibrin
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins

OG000	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 minutes after application of the study treatment.
OG001	Manual Compression - Control	A dry surgical gauze swab will be used to apply by hand an even light pressure onto the resection surface of the liver. Hemostasis will be assessed at 4 minutes after application of the study treatment.