Bleeding Clinical Trial
Official title:
Phase 1 Single-Arm Study Evaluating ClotFoam as an Adjunct to Hemostasis in Abdominal Surgery in Which Liver Bleeding is Encountered
Phase 1 Single-Arm Study Evaluating ClotFoam as an Adjunct to Hemostasis in Abdominal Surgery in Which Liver Bleeding is Encountered.
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).
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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