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

The study will enroll subjects undergoing one of the surgical procedures defined below who have mild to moderate bleeding requiring the use of a topical hemostat.
1. Spinal surgery
Cervical, thoracic, or lumbar discectomy, corpectomy, laminectomy, lateral or interbody fusion. Epidural bleeding typically described as oozing, flowing, or pulsatile, and normally requiring topical adjuncts to hemostasis is necessary to be considered eligible.
The TBS may not be within a bony cavity or other confined area.
2. Vascular Surgery
All subjects undergoing vascular surgery should be systemically heparinized according to
standard procedures. The clamp(s) should be removed to determine if an appropriate TBS with mild to moderate bleeding is present. The clamps should remain off once a TBS is identified and during the treatment and assessment of TTH. If protamine reversal is indicated, it should occur after the 5-minute TTH assessment period is completed, unless a safety concern dictates that it should happen earlier.
a. Arterial bypass surgery
Arterial bypass with an artificial graft (i.e., PTFE or Dacron) including patching and revision procedures, and abdominal aorta aneurysm (AAA) repair. Anastomotic sites at the proximal end of the graft, the distal end of the graft (AAA repair ONLY) or on the suture line of the patch will be available for TTH measurement. The allowed vessels include those of the extremities and the abdominal aorta.
b. Arteriovenous graft formation for hemodialysis access
Artificial graft (i.e., PTFE or Dacron) for hemodialysis access, including revision procedures. Anastomotic sites only at the arterial end of the graft will be available for TTH measurement.
c. Carotid endarterectomy
Carotid endarterectomy requiring a Dacron patch, where the suture line of the patch will be used for TTH assessment.
3. Hepatic resection
Hepatic wedge resection or anatomic resection of 1 to 5 contiguous hepatic segments, which may be combined with surgical procedures involving the pancreas, gall bladder, bile duct or intestines. Subjects undergoing living-related liver donation are also eligible.
4. Soft tissue dissection
The TBS will be identified during the soft tissue dissection related to the primary operative procedure. Primary operative procedures include but are not limited to: abdominoplasty, lower anterior resections, abdominal perineal resections, distal pancreatectomy, esophagectomy, donor skin graft site in limited burn patients, and mastectomy.
Appropriate soft tissue types will include but will not be limited to: loose areolar tissue, fat, lymphatic tissue/lymph node beds, and muscle. The TBS will not involve parenchymal, vascular (anastomotic or vascular repair sites), gastrointestinal or genitourinary soft tissue.

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 bl

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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