Fibrocaps for surgical hemostasis: two randomized, controlled phase II trials

Area of Science:

• Surgical hemostasis
• Biomaterials in medicine

Background:

• Fibrocaps is a novel, ready-to-use dry-powder fibrin sealant.
• It contains human plasma-derived thrombin and fibrinogen.
• Fibrocaps is developed as an adjunct for surgical hemostasis.

Purpose of the Study:

• To evaluate the safety and efficacy of Fibrocaps compared to gelatin sponge alone.
• To assess the time to hemostasis as the primary endpoint.
• To investigate Fibrocaps' performance in various surgical procedures.

Main Methods:

• Two randomized, single-blind controlled trials (FC-002 US and FC-002 NL) were conducted.
• 126 adult patients were randomized to receive either Fibrocaps or gelatin sponge alone.
• Time to hemostasis was measured, with a 28-day safety follow-up.

Main Results:

• Fibrocaps significantly shortened the mean time to hemostasis in both trials (P < 0.001 in US, P = 0.004 in NL).
• Higher incidence of hemostasis within 3, 5, and 10 minutes was observed with Fibrocaps.
• Adverse events were mild to moderate and similar between groups; 5% of Fibrocaps patients developed non-neutralizing antithrombin antibodies.

Conclusions:

• Fibrocaps demonstrated good safety and efficacy.
• The results support the continued clinical development of Fibrocaps.
• Fibrocaps represents a promising novel fibrin sealant for surgical hemostasis.