Clinical trial NCT02264730: ClotFoam as an Adjunct to Hemostasis in Abdominal Surgery - Liver Bleeding is Encountered
Official title: Phase 1 Single-Arm Study Evaluating ClotFoam as an Adjunct to Hemostasis in Abdominal Surgery in Which Liver Bleeding is Encountered
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Bleeding
Lead sponsor: Biomedica Management Corporation
Sponsor class: INDUSTRY
Collaborators: name: Washington University School of Medicine
First posted: 2014-10-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Phase 1 Single-Arm Study Evaluating ClotFoam as an Adjunct to Hemostasis in Abdominal Surgery in Which Liver Bleeding is Encountered.

Detailed description: In any open surgery bleeding usually occurs. Surgeons try to stop the bleeding by using his/her usual surgical practice. These include, but are not limited to: suturing (stitches), ligation (tying up) or cautery (to burn in order to stop or prevent bleeding). It is often necessary for surgeons to use an additional treatment to stop the bleeding. This may include the use of a hemostatic product (used to stop bleeding).

This Phase I study consists of a single arm evaluating the safety of ClotFoam as an adjunct to hemostasis. ClotFoam® is an investigational product-a gelatin-based hydrogel carrying a fibrin monomer-that has been designed for supportive treatment in general surgery for the improvement of hemostasis, where standard techniques are insufficient.

The evaluation will be conducted in 24 patients who are scheduled to undergo elective open surgery in which liver bleeding is encountered requiring control of mild-to- moderate bleeding where standard surgical techniques are expected to be ineffective and/or impractical. All subjects who meet eligibility criteria and who provide informed consent to participate will be assigned to ClotFoam topical treatment. Subjects who will be screened for eligibility to participate in this study will be those who are scheduled to with undergo an elective (non-emergency) hepatic wedge resection or anatomic resection (of 1 to 5 contiguous hepatic segments or a surgical procedure in which liver bleeding is encountered such as removal of the gall bladder (open), bile duct excision wherein an appropriate target bleeding site is identified.

Subjects undergoing living-related liver donation are also eligible. Participants will have post-operative follow ups at day 1,2,5, and 10 post-procedure, 2 weeks post procedure, and 12 weeks post-procedure. The follow up visits will consist of safety evaluations (physical exam, adverse event assessment, laboratory evaluations).

Eligibility criteria: Inclusion Criteria:

* Subject is expected to survive 6 months from the date of screening, If female and of child-bearing potential, subject has a negative serum pregnancy test prior to surgery and agrees to not breast feed her child (if applicable) for duration of study treatment and completion of study follow-up visits, If subject is a sexually active male or a sexually active female of child-bearing potential, subject agrees to use a medically accepted form of contraception from the time of consent to completion of all follow-up study visits

Exclusion Criteria:

* pregnant females

Primary outcomes:
measure: control mild-to-moderate bleeding during surgery in which liver bleeding in encountered
timeFrame: 12 weeks
Secondary outcomes:
measure: Hemostatic Success
timeFrame: 1 minute
measure: Hemostatic Success
timeFrame: 5 minutes
measure: Hemostatic Success
timeFrame: 10 minutes
measure: Hemostatic Success
timeFrame: 10 minutes
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine Barnes Jewish Hospital Clinical Laboratory
state: Missouri
Study officials:
affiliation: Washington University School of Medicine Barnes Jewish Hospital
name: Grant Bochicchio, MD, MPH FACS
role: PRINCIPAL_INVESTIGATOR
References: