The Effectiveness of a Fibrinogen-Thrombin- Collagen-based Hemostatic Agent in an Experimental Arterial Bleeding Model

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Abstract
The hemostyptic agent used in this study is a recently developed material that consists of a collagen fleece containing fibrinogen, thrombin, and aprotinin integrated into its surface (FTCH) with excellent topical hemostyptic properties. The potential use of this substance for cardiovascular surgery was evaluated in a canine arterial bleeding model, which allowed comparison of the new agent with previously used pure collagen (CHF) as well as study of the hemostyptic under elevated blood pressure conditions. The results revealed that FTCH induced reliable hemostasis in 10-mm injuries of the canine hypogastric artery up to a systolic blood pressure of 260 mmHg, whereas bleeding control by CHF alone was impossible. To assess the long-term reliability of FTCH, the dogs were re-explored at intervals of 14 and 31 days after operation. At relaparotomy, the arteries were patent and there was no evidence of recurrent bleeding, thrombosis formation, or aneurysmatic changes. Histologic examinations showed well-healed vascular lesions covered by cell-depleted collagen tissue and a partially resorped hemostyptic. FTCH will not replace adequate surgical techniques but could be useful as a quickly available and easily applicable hemostatic means in otherwise uncontrollable diffuse or acute bleeding in cardiovascular surgery.