CompletedNCT01244425Updated Feb 20, 2013Results posted

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

A Phase 2 interventional study of Fibrin Sealant (FS) VH S/D 500 s-apr and Manual compression in Bleeding (Oozing) in Hepatic Resection, sponsored by Baxter Healthcare Corporation. Completed at 7 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-02-20.

Sponsored by Baxter Healthcare Corporation · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 70
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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 studied

Bleeding (Oozing) in Hepatic Resection

In context

Lead sponsor

Baxter Healthcare Corporation is the lead sponsor of 78 studies on the registry; 1 is open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 3 (30%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Participant)
Enrollment: 70 participants (actual)

Study arms

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
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

Interventions

DrugFibrin Sealant (FS) VH S/D 500 s-apr
Dosage form: spray application; dosage frequency: single application
Also known as: Tisseel
OtherManual compression
Dosage form: surgical gauze swab; dosage frequency: single application

What researchers measure

Primary outcomes

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
Time frame: 4 minutes post start of treatment application

Secondary outcomes

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.
Time frame: 6 minutes after start of treatment application
Percentage of Participants With Intraoperative Hemostasis at 8 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.
Time frame: 8 minutes after start of treatment application
Percentage of Participants With Intraoperative Hemostasis at 10 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.
Time frame: 10 minutes after start of treatment application
Percentage of Participants With Intraoperative Rebleeding After Occurrence of Hemostasis
Intraoperative rebleeding from the treated liver resection surface after occurrence of hemostasis.
Time frame: Intraoperative day 0
Percentage of Participants With Postoperative Rebleeding
Rebleeding until discharged from the surgical ward, defined as any rebleeding from the treated liver resection surface requiring surgical reexploration
Time frame: Postoperative until discharged from surgical ward
Percentage of Participants With Transfusion Requirements Until Discharged From Surgical Ward
Transfusions administered included whole blood, packed red blood cells, fresh frozen plasma, and thrombocyte concentrate.
Time frame: Intra- and postoperative until discharged from surgical ward
Median Total Volume of Postoperative Drainage Fluid Within 48 Hours After Surgery
Time frame: Within 48 hours after surgery

Results

Posted Feb 12, 2013

Participant flow

95 participants were enrolled and screened. 23 were screen failures. 2 participants were discontinued due to: 1 was operated on by a surgeon other than the investigator, and the other underwent a prolonged operation- meaning that the investigational product (IP) could not be used. Therefore, 70 of the 95 enrolled were randomized.

Participant flow — Overall Study
Milestone	FS VH S/D 500 S-apr	Manual Compression - Control
Started	35	35
Completed	32	32
Not completed	3	3
Withdrew: Withdrawal by subject	2	2
Withdrew: Adverse event	1	1

Outcome measures

PrimaryPercentage 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

Time frame:: 4 minutes post start of treatment application
Reported as:: Number · percentage of participants

Percentage of Participants With Intraoperative Hemostasis at 4 Minutes After Treatment Application
percentage of participants	FS VH S/D 500 S-apr	Manual Compression - Control
Percentage of Participants With Intraoperative Hemostasis at 4 Minutes After Treatment Application	82.9 (68.3 to 92.8)	37.1 (22.5 to 53.6)

Statistical analysis

FS VH S/D 500 S-apr vs Manual Compression - Control · likelihood-ratio chi square test · p = <0.001

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

Time frame:: 6 minutes after start of treatment application
Reported as:: Number · percentage of participants

Percentage of Participants With Intraoperative Hemostasis at 6 Minutes After Application of the Randomized Treatment
percentage of participants	FS VH S/D 500 S-apr	Manual Compression - Control
Percentage of Participants With Intraoperative Hemostasis at 6 Minutes After Application of the Randomized Treatment	91.4 (79.3 to 97.8)	57.1 (40.7 to 72.6)

Statistical analysis

FS VH S/D 500 S-apr vs Manual Compression - Control · likelihood ratio chi-square test · p = <0.001

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

Time frame:: 8 minutes after start of treatment application
Reported as:: Number · percentage of participants

Percentage of Participants With Intraoperative Hemostasis at 8 Minutes After Application of the Randomized Treatment
percentage of participants	FS VH S/D 500 S-apr	Manual Compression - Control
Percentage of Participants With Intraoperative Hemostasis at 8 Minutes After Application of the Randomized Treatment	91.4 (79.3 to 97.8)	71.4 (55.3 to 84.5)

Statistical analysis

FS VH S/D 500 S-apr vs Manual Compression - Control · likelihood ratio chi-square test · p = 0.028

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

Time frame:: 10 minutes after start of treatment application
Reported as:: Number · percentage of participants

Percentage of Participants With Intraoperative Hemostasis at 10 Minutes After Application of the Randomized Treatment
percentage of participants	FS VH S/D 500 S-apr	Manual Compression - Control
Percentage of Participants With Intraoperative Hemostasis at 10 Minutes After Application of the Randomized Treatment	94.3 (83.4 to 99.0)	74.3 (58.4 to 86.7)

Statistical analysis

FS VH S/D 500 S-apr vs Manual Compression - Control · likelihood ratio chi-square test · p = 0.017

SecondaryPercentage of Participants With Intraoperative Rebleeding After Occurrence of Hemostasis

Intraoperative rebleeding from the treated liver resection surface after occurrence of hemostasis.

Time frame:: Intraoperative day 0
Reported as:: Number · percentage of participants

Percentage of Participants With Intraoperative Rebleeding After Occurrence of Hemostasis
percentage of participants	FS VH S/D 500 S-apr	Manual Compression - Control
Percentage of Participants With Intraoperative Rebleeding After Occurrence of Hemostasis	2.9 (0.2 to 12.0)	8.6 (2.2 to 20.7)

Statistical analysis

FS VH S/D 500 S-apr vs Manual Compression - Control · likelihood ratio chi-square test · p = 0.293

SecondaryPercentage of Participants With Postoperative Rebleeding

Rebleeding until discharged from the surgical ward, defined as any rebleeding from the treated liver resection surface requiring surgical reexploration

Time frame:: Postoperative until discharged from surgical ward
Reported as:: Number · Percentage of participants

Percentage of Participants With Postoperative Rebleeding
Percentage of participants	FS VH S/D 500 S-apr	Manual Compression - Control
Percentage of Participants With Postoperative Rebleeding	2.9 (0.1 to 14.9)	0.0 (0.0 to 10.0)

Statistical analysis

FS VH S/D 500 S-apr vs Manual Compression - Control · likelihood ratio chi-square test · p = 0.237

SecondaryPercentage of Participants With Transfusion Requirements Until Discharged From Surgical Ward

Transfusions administered included whole blood, packed red blood cells, fresh frozen plasma, and thrombocyte concentrate.

Time frame:: Intra- and postoperative until discharged from surgical ward
Reported as:: Number · percentage of participants

Percentage of Participants With Transfusion Requirements Until Discharged From Surgical Ward
percentage of participants	FS VH S/D 500 S-apr	Manual Compression - Control
Percentage of Participants With Transfusion Requirements Until Discharged From Surgical Ward	40.0 (24.9 to 56.5)	42.9 (27.4 to 59.3)

Statistical analysis

FS VH S/D 500 S-apr vs Manual Compression - Control · likelihood ratio chi-square test · p = 0.808

SecondaryMedian Total Volume of Postoperative Drainage Fluid Within 48 Hours After Surgery

Time frame:: Within 48 hours after surgery
Reported as:: Median · mL

Median Total Volume of Postoperative Drainage Fluid Within 48 Hours After Surgery
mL	FS VH S/D 500 S-apr	Manual Compression - Control
Median Total Volume of Postoperative Drainage Fluid Within 48 Hours After Surgery	415.0 (70 to 10800)	410.0 (0 to 3690)

Adverse events

Collected over Throughout study period (9 months). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
FS VH S/D 500 S-apr	—	9/35 (25.7%)	22/35 (62.9%)
Manual Compression - Control	—	11/35 (31.4%)	23/35 (65.7%)

Most frequent serious events

Showing 10 of 21

Most frequent serious events
Event	FS VH S/D 500 S-apr	Manual Compression - Control
POST PROCEDURAL BILE LEAKInjury, poisoning and procedural complications	4/35	3/35
POSTOPERATIVE ABSCESSInfections and infestations	0/35	3/35
ASCITESGastrointestinal disorders	0/35	2/35
HEPATIC HAEMATOMAInjury, poisoning and procedural complications	0/35	2/35
DISSEMINATED INTRAVASCULAR COAGULATIONBlood and lymphatic system disorders	1/35	0/35
FAECALOMAGastrointestinal disorders	0/35	1/35
RETROPERITONEAL HAEMORRHAGEGastrointestinal disorders	0/35	1/35
MULTI-ORGAN FAILUREGeneral disorders	1/35	1/35
PORTAL VEIN THROMBOSISHepatobiliary disorders	1/35	0/35
LIVER ABSCESSInfections and infestations	1/35	1/35

Most frequent other events

Showing 10 of 17

Most frequent other events
Event	FS VH S/D 500 S-apr	Manual Compression - Control
PLEURAL EFFUSIONRespiratory, thoracic and mediastinal disorders	7/35	9/35
HYPOALBUMINAEMIAMetabolism and nutrition disorders	5/35	2/35
HYPOKALAEMIAMetabolism and nutrition disorders	1/35	5/35
ASCITESGastrointestinal disorders	1/35	4/35
INFECTIONInfections and infestations	2/35	4/35
POST PROCEDURAL HAEMATOMAInjury, poisoning and procedural complications	4/35	2/35
IMPAIRED HEALINGGeneral disorders	1/35	3/35
OEDEMA PERIPHERALGeneral disorders	1/35	3/35
OPERATIVE HAEMORRHAGEInjury, poisoning and procedural complications	1/35	3/35
PYREXIAGeneral disorders	0/35	2/35

Baseline characteristics

Age Continuous
Age Continuous(years)	FS VH S/D 500 S-apr	Manual Compression - Control	Total
Mean	54.7 ± 14.5	59.8 ± 12.8	57.3 ± 13.9

Sex: Female, Male
Sex: Female, Male(Participants)	FS VH S/D 500 S-apr	Manual Compression - Control	Total
Female	15	16	31
Male	20	19	39

Region of Enrollment
Region of Enrollment(participants)	FS VH S/D 500 S-apr	Manual Compression - Control	Total
Germany	35	35	70

Study locations

7 sites

Berlin, Germany
Essen, Germany
Hannover, Germany
Heidelberg, Germany
Jena, Germany
Leipzig, Germany
Tübingen, Germany

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 20, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01244425
Lead sponsor: Baxter Healthcare Corporation
Collaborators: Baxter Innovations GmbH
Responsible party: Sponsor
First posted: Nov 19, 2010
Start date: Nov 2010
Primary completion: Jul 2011
Completion: Jul 2011
Results posted: Feb 12, 2013
Last update: Feb 20, 2013

Study contacts

Baxter BioScience Medical Director, MD

study director · Baxter Healthcare Corporation

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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