Pharmacological properties : תכונות פרמקולוגיות

Pharmacodynamic Properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Antihaemorrhagics, local hemostatics, ATC code: B02BC 
Mechanism of action

The fibrin adhesion system initiates the last phase of physiological blood coagulation.
Conversion of fibrinogen into fibrin occurs by the splitting of fibrinogen into fibrin monomers and fibrinopeptides. The fibrin monomers aggregate and form a fibrin clot. Factor XIIIa, which is activated from factor XIII by thrombin, crosslinks fibrin. Calcium ions are required for both, the conversion of fibrinogen and the cross linkage of fibrin.

As wound healing progresses, increased fibrinolytic activity is induced by plasmin and decomposition of fibrin to fibrin degradation products is initiated.

Clinical efficacy and safety

Randomized, single-blind clinical trials with VeraSealTM were conducted in subjects undergoing vascular, parenchymous tissue and soft tissue surgery demonstrating haemostasis, and suture support in vascular surgery.

During the vascular surgery study 225 subjects were enrolled and underwent vascular surgical procedures utilizing polytetrafluoroethylene graft material on end-to-side arterial anastomosis or on upper extremity vascular access arterial anastomosis. The mean age of the study population and its standard deviation was 63.2 (9.5) years. The most frequent surgery types were femoral- popliteal bypass grafting, upper extremity vascular access for hemodialysis, and ilio-femoral bypass grafting. VeraSealTM was shown to be superior to the control group (manual compression) in achieving hemostasis by 4 minutes. The rate of hemostasis at the target bleeding site by 4 minutes was 76.1% in the VeraSealTM treatment group and was 22.8% in the control group.
During parenchymous tissue surgery study 325 subjects were enrolled and underwent liver resections. The mean age of the study population and its standard deviation was 57.9 (14.5) years. VeraSealTM was shown to be superior to the control group (oxidized regenerated cellulose) in achieving hemostasis by 4 minutes. The rate of hemostasis at the target bleeding site by 4 minutes was 92.8% in the VeraSealTM treatment group and was 80.5% in the control group.

During soft tissue surgery study 327 subjects were enrolled and underwent pelvic and retroperitoneal surgical procedures, and abdominoplasties and mastopexies. The mean age of the study population and its standard deviation was 47.2 (18.4) years. The most frequent surgery types were simple or radical hysterectomies, abdominoplasties, and radical cystectomies.
VeraSealTM was shown to be non-inferior to the control group (oxidized regenerated cellulose) in achieving hemostasis by 4 minutes. The rate of hemostasis at the target bleeding site by 4 minutes was 82.8% in the VeraSealTM treatment group and was 77.8% in the control group.

Paediatric population

Eleven paediatric subjects aged 16 years or younger were treated with VeraSealTM in the described clinical studies.

Pharmacokinetic Properties

5.2 Pharmacokinetic properties

VeraSealTM is intended for epilesional use only. Intravascular administration is contraindicated.
Consequently, intravascular pharmacokinetic studies were not performed in man.

Fibrin sealant/haemostatic products are metabolised in the same way as endogenous fibrin by fibrinolysis and phagocytosis.