Evaluation of an Absorbable Surgical Hemostatic Agent: Thrombi-Gel® Versus Gelfoam-Thrombin

This is a prospective, randomized, multi-center investigation with a minimum of seventy five
(75) study subjects designed to evaluate the safety and effectiveness of the Thrombi-Gel
product as an absorbable hemostat in the surgical patient population.

Subjects who are undergoing orthopedic/spinal, general, cardiac, hepatic or vascular
surgical procedures should be considered for this investigation. Subjects can be
pre-screened utilizing standard of care data for the specified inclusion/exclusion criteria
to ensure that they are eligible for treatment in the investigation. If the subject appears
to qualify for the investigation, the subject will then be asked to give his/her written
informed consent. If, during surgery, the surgeon encounters a bleeding site that he or she
is unable or unwilling to easily control due to failure or impracticality of conventional
methods (sutures and/or cautery), the subject may be enrolled and randomized to receive
either the investigational or control treatment. If the subject has multiple bleeding sites,
each site to a maximum of 5 sites, may be treated with the assigned surgical hemostat.
However, only the first site treated will be used to determine study objectives. All
subjects will be followed through their hospitalization.

A follow-up evaluation will be conducted at approximately 30 and 60 days post-procedure to
determine the long-term effectiveness of the hemostatic treatment received, incidence of
late adverse events, and interim immunologic response to the study treatment device.
Follow-up evaluations will include obtaining a blood specimen that evaluates for antibody
development, coagulation, and Factor Va testing. Blood samples will be sent to independent
labs for analysis.

From baseline to the final study exam, data pertaining to the investigational objectives
will be recorded on the appropriate case report forms at the predetermined study intervals.
The investigation will be conducted at a minimum of five (5) sites, but no more than fifteen
(15) sites.

Inclusion Criteria:

1. The subject is 18 years of age or older

2. The subject is undergoing an orthopedic/spinal, general, cardiac, hepatic, or
vascular surgical procedure (neurosurgical, ophthalmic or urological procedures must
be excluded)

3. The subject is willing and able to provide appropriate informed consent

4. The subject is willing and able to comply with the requirements of the study
protocol, including the predefined follow-up evaluations

Inclusion criteria to be determined during the surgical procedure:

1. The subject has an intraoperative bleeding site which the surgeon is unable or
unwilling to easily control with conventional methods (cautery, sutures)

Exclusion Criteria:

1. The subject is known or suspected to be pregnant (verified in a manner consistent
with institution's standard of care), or is lactating

2. The subject has a known allergy to bovine derived products or any other materials
used in the Thrombi-Gel product

3. The subject has an active infection at the surgical site

4. The use of hemostatic agents are contraindicated for the subject

5. The subject has a known bleeding disorder (including thrombocytopenia [< 100,000
platelet count], thrombobasthenia, hemophilia, or von Willebrand disease)

6. The subject has received antibiotic solutions/powders at the intended application
site

7. The subject has had surgery at the intended application site ≤ 6 months before the
current surgical procedure

8. The subject is unavailable for follow-up

9. The subject is currently participating in another investigational device or drug
trial

10. The subject has previously participated in this trial (Protocol 0307) or the
Thrombi-Paste trial (Protocol 0507)