Tachosil Fibrin Sealant Patch

Package to Patient + Hemostasis Power

Clinical Trial Data

Bleeding controlled at 3 mins in APX 75% of patients

Efficacy Results in Cardiovascular Surgery, by Treatment, Intent-to-Treat Population

Bleeding controlled at 3 minutes in approximately 75% of patients treated with TachoSil® patch1

Methods

TachoSil® Patch (n=59)

Comparator* (n=60)

Methods

The ability of TachoSil® patch to control bleeding in cardiovascular surgery was evaluated in an open-label, 1:1 randomized, parallel-group study comparing TachoSil® patch with a comparator treatment.* ITT population = 119 patients.

The most common ARs in the TachoSil® (N=62) vs. comparator (N=57) groups, respectively, of the CV trial were atrial fibrillation (29% vs. 25%), pleural effusion (23% vs. 19%) and pyrexia (6% vs. 5%).

* The comparator group was treated using hemostatic fleece without additional active coagulation-stimulating compounds.
† The 95% confidence intervals at 3 minutes were 0.635 to 0.857 (TachoSil®) and 0.214 to 0.453 (comparator).
‡ The 95% confidence intervals at 6 minutes were 0.893 to 1.000 (TachoSil®) and 0.603 to 0.831 (comparator).

Bleeding controlled at 3 mins in APX 81% of patients

Efficacy Results in Hepatic Surgery, by treatment, Intent-to-Treat Population

Bleeding controlled at 3 minutes in approximately 81% of patients treated with TachoSil® patch1

Methods

TachoSil® Patch (n=114)

Comparator* (n=110)

Methods

The ability of TachoSil® patch to control bleeding in hepatic resection surgery was evaluated in a randomized, open label, parallel-group, multi-center trial to compare the efficacy and safety of TachoSil® patch versus a comparator treatment.* ITT population = 224 patients.

The most common ARs in the TachoSil® (N=114) vs. comparator (N=109) groups, respectively, of the hepatic resection trial were nausea (30% vs. 27%) and anemia (23% vs. 21%).

* The comparator group was treated with hemostatic fleece material made of oxidized cellulose polymer.

Indications and Usage

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) is ineffective or impractical.

Not for use in place of sutures or other forms of mechanical ligation in treatment of major arterial or venous bleeding. Not for use in children under one month of age.

Selected Important Risk Information

  • TachoSil® Fibrin Sealant Patch contains collagen which may adhere to bleeding surfaces. May carry a risk of gastrointestinal obstruction in abdominal surgery due to tissue adhesions. To prevent the development of tissue adhesions at undesired sites, ensure tissue areas outside the application area are adequately cleansed before administration of TachoSil.

For more Information, please see Detailed Important Risk Information and Full Prescribing Information.