Clinical Trial Details


Research Study Summary

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


The primary objective of the study is to demonstrate the superiority of Fibrocaps plus gelatin sponge, as compared to gelatin sponge alone, for achieving hemostasis in subjects with mild to moderate surgical bleeding during spine, liver, vascular or soft tissue surgery.

Patient Inclusion Criteria:

  • 18 Years and older
  • Subject has signed an institutional review board/independent ethics committee (IRB/IEC)-approved informed consent document
  • Subject is undergoing one of the 4 surgical procedures described
  • Subject age is >18 years at time of consent
  • If female and of child-bearing potential, subject has negative pregnancy test within 14 days prior to treatment and is not breast-feeding
  • 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
  • Mild to moderate surgical bleeding

Patient Exclusion Criteria:

  • Subject has known antibodies or hypersensitivity to thrombin or other coagulation factors
  • Subject has history of heparin-induced thrombocytopenia (only for vascular subjects where heparin use is required)
  • Subject has known allergy to porcine gelatin
  • Subject is unwilling to receive blood products
  • 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)
  • 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
  • Platelets < 100 x109 PLT/L during screening

To Learn more

CW ID: 183324
Date Last Changed: July 16, 2013

Clinical Trial Snapshot

Both Male and Female
18 and up
Overall Status
Facility Type


Christine Goetz, BA; CCRC
MultiCare Health System
314 Martin Luther King, Jr. Way, Suite 402
Tacoma, WA 98405
Phone: 253-403-7193

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Research Center Information:

MultiCare Health System

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