Phase 2 N=70 Randomized Single-blind Treatment

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

Bleeding (Oozing) in Hepatic Resection

Bottom Line

View on ClinicalTrials.gov: NCT01244425 ↗

Enrolled (actual)

Serious AEs

28.6%

Results posted

Feb 2013

Primary outcome: Primary: Percentage of Participants With Intraoperative Hemostasis at 4 Minutes After Treatment Application — 82.9; 37.1 percentage of participants — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Fibrin Sealant (FS) VH S/D 500 s-apr (Drug); Manual compression (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Baxter Healthcare Corporation
Primary completion: Jul 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Intraoperative Hemostasis at 4 Minutes After Treatment Application	82.9; 37.1	<0.001 sig
SECONDARY Percentage of Participants With Intraoperative Hemostasis at 6 Minutes After Application of the Randomized Treatment	91.4; 57.1	<0.001 sig
SECONDARY Percentage of Participants With Intraoperative Hemostasis at 8 Minutes After Application of the Randomized Treatment	91.4; 71.4	0.028 sig
SECONDARY Percentage of Participants With Intraoperative Hemostasis at 10 Minutes After Application of the Randomized Treatment	94.3; 74.3	0.017 sig
SECONDARY Percentage of Participants With Intraoperative Rebleeding After Occurrence of Hemostasis	2.9; 8.6	0.293
SECONDARY Percentage of Participants With Postoperative Rebleeding	2.9; 0.0	0.237
SECONDARY Percentage of Participants With Transfusion Requirements Until Discharged From Surgical Ward	40.0; 42.9	0.808
SECONDARY Median Total Volume of Postoperative Drainage Fluid Within 48 Hours After Surgery	415.0; 410.0	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01244425). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.