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A Phase 3, Randomized, Single-blind, Controlled Trial of Topical Fibrocaps™ in Intraoperative Surgical Hemostasis

Phase 3
18 Years
Open (Enrolling)
Mild or Moderate Surgical Bleeding

Thank you

Trial Information

A Phase 3, Randomized, Single-blind, Controlled Trial of Topical Fibrocaps™ in Intraoperative Surgical Hemostasis

Inclusion Criteria:

1. Subject has signed an institutional review board/independent ethics committee
(IRB/IEC)-approved informed consent document

2. Subject is undergoing one of the 4 surgical procedures described

3. Subject age is >18 years at time of consent

4. If female and of child-bearing potential, subject has negative pregnancy test during
screening and is not breast-feeding

5. 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

6. Subject has not received blood transfusion between screening and study treatment

7. Presence of mild to moderate surgical bleeding

8. Absence of intra-operative complications

9. No intra-operative use of a topical hemostat containing thrombin prior to study

10. Approximate bleeding site surface area of less than or equal to 100 cm2

Exclusion Criteria:

1. Subject has known antibodies or hypersensitivity to thrombin or other coagulation

2. Subject has history of heparin-induced thrombocytopenia (only for vascular subjects
where heparin use is required)

3. Subject has known allergy to porcine gelatin

4. Subject is unwilling to receive blood products

5. Has any clinically-significant coagulation disorder that may interfere with the
assessment of efficacy or pose a safety risk to the subject according to the
Investigator, or baseline abnormalities of INR > 2.5 or aPTT > 100 seconds during
screening that are not explained by current drug treatment (e.g., warfarin, heparin)

6. Aspartate Aminotransferase (ASAT/AST ) or Alanine aminotransferase (ALAT/ALT) > 3 x
upper limit normal range during screening, except for subjects undergoing liver
resection surgery or with a diagnosis of liver metastases where there is no upper
limit for these analytes due to the nature of their disease

7. Platelets < 100 x109 PLT/L during screening

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

Time to Hemostasis (TTH)

Outcome Time Frame:

Within 5 minutes of treatment

Safety Issue:


Principal Investigator

Paul Frohna, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

ProFibrix, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

May 2012

Completion Date:

June 2013

Related Keywords:

  • Mild or Moderate Surgical Bleeding
  • fibrin sealant
  • thrombin
  • fibrinogen
  • hemostasis
  • Hemorrhage



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