Patients undergoing vascular surgical procedures will be included in this study. This will include patients with peripheral vascular disease and also patients with renal disease who require vascular access for dialysis.
Conditions
Interventions
Product Name: Fibrin Sealant 2 (FS2)
Product Code: FS2
Pharmaceutical Form: Sealant
INN or Proposed INN: Human Thrombin
CAS Number: 9002
Sponsors
OMRIX biopharmaceuticals Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female patients, 18 years or older, requiring elective, primary or repeat vascular procedures with at least one end-to-side femoral or upper extremity vascular access arterial anastomosis (e.g.femoral-femoral, femoral-popliteal, femoral-tibial, ilio-femoral, aorto-bifemoral, abdominal aortic aneurysm, upper extremity vascular access for dialysis) using PTFE grafts, polypropylene sutures and 1:1 needle-to-thread ratio. 2. Following initial arterial clamp release, the study surgeon determines that adjunctive measures are needed to obtain haemostasis at the study anastomosis. 3. Patients must be willing to and capable of participating in the study, and provide written informed consent. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients are excluded due to the following criteria as these may influence obtaining haemostasis: re-vascularisation using autologous conduits (e.g. saphenous vein) or prosthetic material other than PTFE; Patients with autoimmune immunodeficiency diseases (including known HIV); Patients who are undergoing emergency surgery will be excluded as there would be insufficient time to obtain consent; Patients with any intra-operative findings may preclude conduct of the study procedure; In order to protect vulnerable groups, patients who are current drug or alcohol abusers will be excluded; Patients with known intolerance to heparin, blood products or to one of the components of the study products will be excluded to minimise the risk of allergic reaction; Patients who are unwilling to receive blood products are also excluded as FS2 is produced from human plasma; Patients who have participated in another investigational drug or device research study within 30 days of enrollment will also be excluded; As the safety of the product in human pregnancy has not been established, pregnant patients will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): bleeding at 4 minutes.;Main Objective: The primary objective of this study is to evaluate whether the fibrin sealant (FS2) reduces time to haemostasis during vascular surgical procedures. Success rate of the FS2 group will be compared to success rate of the Manual Compression group. Success will be defined as the absence of bleeding at 4 minutes following randomisation.; Secondary Objective: The secondary objectives of this study are to compare the two treatment groups with respect to the following parameters: Absence of bleeding at study anastomotic site 7 and 10 minutes following randomisation ; intra-operative blood loss from study anastomotic site following clamp removal; incidence of treatment failure; incidence of potential bleeding related complications up to Five Week Follow-Up; Adverse events up to Five Week Follow-Up. | — |
Countries
United Kingdom
Outcome results
None listed