U.S. Study of Fibrocaps in Surgical Hemostasis

Completed · Not applicable

Conditions studied: Postoperative Hemorrhage

In brief

The purpose of this study was to characterize the safety and hemostatic activity of topical Fibrocaps in surgical patients when control of mild to moderate bleeding by standard surgical techniques was ineffective and/or impractical.

Key facts

Study ID

NCT01256164

Run by

Mallinckrodt

People needed

70

Starts

2010-12-01

Expected to finish

2011-10-01

Last updated by the study team

2017-09-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• male or female 18 years of age or older
• Subjects who are able and willing to provide written and signed informed consent
• All subjects willing to use a medically accepted form of contraception from the time of consent to completion of all follow-up study visits
• A life expectancy of at least one year
• Intra-Operative inclusion criteria
• Presence of mild or moderate bleeding/oozing when control by conventional surgical techniques, including but not limited to suture, ligature and cautery is ineffective or impractical
• Absence of intraoperative complications other than bleeding which, in the opinion of the investigator, may interfere with the assessment of efficacy or safety
• No intraoperative use of a topical hemostat containing thrombin
• Approximate Target Bleeding Site surface area of no more than 100 square centimeters

You may not qualify if…

• Pregnant or lactating women
• Has a known intolerance to blood products or to Fibrocaps components
• Unwilling to receive human blood products
• Subject has a known allergy to porcine gelatin
• Has a mental or physical condition that would, in the opinion of the investigator, place the subject at an unacceptable risk or render the subject unable to meet the requirements of the protocol
• Currently participating or has participated in another clinical study involving another investigational agent within 4 weeks of the start of this trial, or is planning participation in another clinical trial during the 4 weeks after surgery
• 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
• Aspartate Aminotransferase (AST) or Alanine aminotransferase (ALT) 3 times (or more) the upper limit normal range during screening, except for subjects undergoing liver resection surgery where there is no upper limit for these analytes due to the nature of their disease.
• Platelets < 10 x 10\^9 /L during screening
• Activated partial thromboplastin time (aPTT) > 100 seconds during screening
• International normalized ratio (INR)greater than 2.5 during screening

Where it is running

• Various sites — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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