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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 672

Inclusion Criteria

Inclusion Criteria (pre-surgery):
1. Subject has signed an institutional review board/independent ethics committee
(IRB/IEC)-approved informed consent document
2. Subject is undergoing one of the surgical procedures described above
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
Inclusion Criteria (during surgery):
1. Subject has not received blood transfusion between screening and study treatment.
2. 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.
3. Absence of intra-operative complications other than bleeding which, in the opinion of the Investigator, may interfere with the assessment of efficacy or safety.
4. No intra-operative use of a topical hemostat containing thrombin prior to study treatment.
5. 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 404
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 268

Exclusion Criteria

Exclusion Criteria:
1. Subject has known antibodies or hypersensitivity to thrombin or other coagulation
factors
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
8. Subject has medical, social or psychosocial factors that, in the opinion of the
Investigator, could impact safety or compliance with study procedures
9. 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 4 weeks after surgery

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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