ClotFoam as an Adjunct to Hemostasis in Abdominal Surgery - Liver Bleeding is Encountered

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02264730
• Other study ID #: 10-030H2
• Status: Recruiting
• Phase: Phase 1
• First received: October 6, 2014
• Last updated: October 14, 2014
• Start date: July 2014
• Est. completion date: January 2015

Study information

• Verified date: October 2014
• Source: Biomedica Management Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bleeding
• Hemorrhage

Intervention

Drug:
• ClotFoam
Patient has not received blood products between screenings

Locations

Country	Name	City	State
United States	Washington University School of Medicine Barnes Jewish Hospital Clinical Laboratory	St. Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Biomedica Management Corporation	Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	control mild-to-moderate bleeding during surgery in which liver bleeding in encountered	evaluated intermittently during those 12 weeks	12 weeks	No
Secondary	Hemostatic Success	Percentage of subjects who achieve hemostatic success within the 1-minute TTH assessment period.	1 minute	No
Secondary	Hemostatic Success	Percentage of subjects who achieve hemostatic success within the 5-minute TTH assessment period.	5 minutes	No
Secondary	Hemostatic Success	Percentage of subjects who achieve hemostatic success within the 10- minute TTH period.	10 minutes	No
Secondary	Hemostatic Success	Incidence of treatment failures (if hemostasis is not achieved within 10 minutes or if bleeding required additional intervention during the 2nd 10 minute observation period.	10 minutes	No