Hepatic surgery specifically, hepatic wedge resection or anatomic resection of 1 to 5 contiguous hepatic segments, and/or other hepatic surgery, any of which may be combined with other surgical procedures involving the gall bladder or intestines with presence of mild to moderate bleeding/oozing MedDRA version: 18.0 Level: LLT Classification code 10053001 Term: Surgical haemostasis System Organ Class: 100000004865
Conditions
Interventions
Product Name: Fibrocaps™ (Raplixa™)
Product Code: PRO-0601
Pharmaceutical Form: Sealant
INN or Proposed INN: NA
CAS Number: 9001-32-5
Other descriptive name: HUMAN FIBRINOGEN
Concentration unit: mg/g
Sponsors
ProFibrix, A wholly owned subsidary of the Medicines Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects may be included in the study if they meet all of the following criteria: Pre-surgery: 1. Subject has signed an independent ethics committee (IEC)-approved informed consent document 2.Subject is undergoing hepatic wedge resection or anatomic resection of 1 to 5 contiguous hepatic segments, and/or other hepatic surgery, any of which may be combined with other surgical procedures involving the gall bladder or intestines 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 During surgery: 6. Presence of mild to moderate bleeding/oozing when control by conventional surgical techniques, including but not limited to suture, ligature and cautery is ineffective or impractical 7. Absence of intra-operative complications other than bleeding which, in the opinion of the investigator, may interfere with the assessment of efficacy or safety 8. Approximate TBS surface area of = 100 cm2 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 136 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1.Subject has known hypersensitivity to Fibrocaps or any of its components 2.Subject has known allergy to porcine gelatin 3.Subject has known hypersensitivity to Tachosil, or any of the excipients included in Tachosil 4.Subject is unwilling to receive blood products 5.Subject is having hepatic surgery due to emergency-traumatic event 6.Subject requires extrahepatic bile duct resection (common bile duct resection or resection of the bile duct which leads to performing an anastomoses between the bile duct and small bowel) and biliary anastomosis, and/or pancreatic resections 7.Subject 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 international normalized ratio (INR) > 2.5 or activated partial thromboplastin time (aPTT) > 100 seconds during screening that are not explained by current drug treatment (e.g., warfarin, heparin) 8.Subject has platelet count < 100 x109 PLT/L during screening 9.Subject has medical, social or psychosocial factors that, in the opinion of the investigator, could impact safety or compliance with study procedures 10.Subject is currently participating or has participated in another clinical study involving another investigational agent within 4 weeks of the planned date of surgery or is planning participation in another clinical trial within 6 weeks after surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to demonstrate the non-inferiority or superiority of Fibrocaps plus gelatin sponge compared to Tachosil when control of mild to moderate bleeding with conventional surgical techniques is ineffective or impractical.;Secondary Objective: To further evaluate the efficacy and safety of Fibrocaps plus gelatin sponge compared to Tachosil. ;Primary end point(s): The primary endpoint of this trial is the proportion of subjects, undergoing hepatic resection, who achieve hemostasis at 3 minutes. ;Timepoint(s) of evaluation of this end point: Fibrocaps: At t = 2 min. and t= 3 min. and every 30 seconds thereafter up until 5 minutes or until hemostasis is reached (whatever comes first). Tachosil: At t= 3 min. and every 30 seconds thereafter up until 5 minutes or until hemostasis is reached (whatever comes first). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • The proportion of subjects who reach hemostasis at 2 minutes (Fibrocaps only) and 4 minutes • Restricted mean TTH from 3 to 5 minutes • Evaluation of safety by the incidence, severity and relationship of AEs, and clinical laboratory abnormalities by treatment group ;Timepoint(s) of evaluation of this end point: Fibrocaps: At t = 2 min. and t= 3 min. and every 30 seconds thereafter up until 5 minutes or until hemostasis is reached (whatever comes first). Tachosil: At t= 3 min. and every 30 seconds thereafter up until 5 minutes or until hemostasis is reached (whatever comes first). From signing of consent up until Visit 4: Evaluation of safety by the incidence, severity and relationship of AEs, and clinical laboratory abnormalities | — |
Countries
Austria, Germany
Contacts
Public ContactSandra Kohler
ProFibrix, A wholly owned subsidary of the Medicines Company
Outcome results
None listed