Author: Iswanto Sucandy, MD, FACS (Hepatobiliary Surgery, AdventHealth Tampa)
Tachosil received FDA approval on April 6, 2010 for Baxter & Nycomed as a hemostatic product to be used during cardiovascular and hepatic surgery.
TachoSil is a Fibrin Sealant Patch comprised of human fibrinogen and human thrombin coated onto an equine collagen sponge. The collagen sponge serves as a flexible and mechanically stable carrier for the active substances. It is indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular and hepatic surgery, when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) are ineffective or impractical.
The mechanism of action is based on the interaction between human fibrinogen and human thrombin and the physiology of the fibrin clot formation. Upon contact with a bleeding wound surface, the active substances coated onto the equine collagen patch become dissolved and partly diffuse into the wound surface. The subsequent fibrinogen-thrombin reaction initiates the last step in the cascade of biochemical reactions, which is conversion of fibrinogen into fibrin monomers that further polymerize to form the final fibrin clot. Fibrin clots produce complete hemostasis.
The effectiveness of TachoSil has been evaluated in a study of 119 cardiovascular surgery patients. Nearly three-quarters (74.6 percent) of those who received TachoSil, achieved hemostasis within three minutes compared with 33.3 percent in the control group.
Tachosil is contraindicated for intravascular application, which may result in life-threatening thromboembolic events. Tachosil should not be used in patients with known hypersensitivity to human blood products or horse proteins. Additionally, Tachosil should not be applied in contaminated or infected areas.
The product is not intended to replace sutures or other forms of mechanical ligation in treatment of major arterial or venous bleeding. It is also not for use in children under one month of age.
Video of product use and application: