TachoSil® Fibrin Sealant Patch

The TachoSil Patch assists in managing mild to moderate blood loss during surgery involving cardiovascular and liver tissue, when standard surgical techniques are ineffective or impractical. TachoSil merges the efficacy of a fibrin sealant with the flexibility of a surgical patch to deliver focused hemostasis.

TachoSil Fibrin Sealant Patch

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.

Full Prescribing Information Unsolicited Request for Off-Label Use

The Benefits of TachoSil at a Glance

TachoSil is a fixed combination of a collagen matrix coated with the active human coagulation factors fibrinogen and thrombin.

  • Improves hemostasis1, 2
  • Closed cell collagen matrix
  • Flexible, accommodates irregular surfaces
  • Wet or dry field application

Proven Effective in Cardiovascular Surgery

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.

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


Proven Effective in Hepatic Surgery

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 versus a standard treatment.* ITT population = 224 patients.

Bleeding was controlled at 3 minutes in approximately 81% of patients treated with TachoSil patch.2

How to apply TachoSil®

1

Open aluminum blister

The cover film can be removed outside the sterile zone. The inner sterile blister must be opened in a sterile environment.

2

Open plastic blister

Peel off the cover film in the sterile zone with sterile gloves.

3

Grasp

Remove the fleece from the sterile packaging with forceps.

4

Trim (optional)

Important: TachoSil® should extend 1-2 cm beyond the edge of the wound.

5

Moisten (optional)

If the wound is dry, moistening before application is recommended. If the wound is wet, TachoSil® can be dry when applied.

6

Apply

Apply with the yellow active side facing the wound. If more than one patch is used, overlap patches by at least 1 cm.

7

Press in place

Press in place slightly for at least 3 minutes, ideally with a moist compress.

8

Remove the compress

Remove carefully, using forceps if necessary.

1

Open aluminum blister

The cover film can be removed outside the sterile zone. The inner sterile blister must be opened in a sterile environment.

2

Open plastic blister

Peel off the cover film in the sterile zone with sterile gloves.

3

Grasp

Remove the fleece from the sterile packaging with forceps.

4

Trim (optional)

Important: TachoSil® should extend 1-2 cm beyond the edge of the wound.

5

Moisten (optional)

If the wound is dry, moistening before application is recommended. If the wound is wet, TachoSil® can be dry when applied.

6

Apply

Apply with the yellow active side facing the wound. If more than one patch is used, overlap patches by at least 1 cm.

7

Press in place

Press in place slightly for at least 3 minutes, ideally with a moist compress.

8

Remove the compress

Remove carefully, using forceps if necessary.

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.

Important Risk Information
  • Do not apply Tachosil® fibrin sealant patch intravascularly. Intravascular application of Tachosil® can result in life-threatening thromboembolic events. Thrombosis can occur if Tachosil® is exposed intravascularly. Ensure that Tachosil® is applied to the surface of cardiac, vascular or hepatic tissue only.
  • Do not use Tachosil® in individuals with known hypersensitivity to human blood products or horse proteins.
  • Can cause hypersensitivity or allergic/anaphylactoid reactions with first-time or repetitive application.
  • Avoid application to contaminated areas of the body or in the presence of active infection.
  • Tachosil® contains collagen which may adhere to bleeding surface. 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®.
  • Avoid packing in cavities or closed spaces because this may cause compression of underlying tissue. Use the least number of patches required to cover the entire bleeding area. Do not pack. Remove any unattached pieces of Tachosil® fibrin sealant patch.
  • May carry a risk of transmitting infectious agents, such as viruses, and theoretically, the variant Creutzfeldt-Jakob disease (vCJD) agent and the Creutzfeldt-Jakob disease (CJD) agents, despite manufacturing steps designed to reduce the risk of viral transmission.
  • The most common adverse reactions reported in >1% of patients during clinical trials were anemia, nausea and vomiting, fever, abdominal pain, increased white blood cell count, ascites, itching, atrial fibrillation, pleural effusion, gastrointestinal hemorrhage, wound infection, hypophosphatemia, urinary tract infection and post-procedural bile leakage in hepatic surgery.

References

  1. (Maisano F, et al. TachoSil surgical patch versus conventional haemostatic fleece material for control of bleeding in cardiovascular surgery: a randomised controlled trial. Eur J Cardiothorac Surg. 2009 Oct;36(4):708-14.)
  2. Genyk Y, Kato T, Pomposelli JJ, Wright JK Jr, Sher LS, Tetens V, Chapman WC. Fibrin Sealant Patch (TachoSil) vs Oxidized Regenerated Cellulose Patch (Surgicel Original) for the Secondary Treatment of Local Bleeding in Patients Undergoing Hepatic Resection: A Randomized Controlled Trial. J Am Coll Surg. 2016 Mar;222(3):261-8. doi: 10.1016/j.jamcollsurg.2015.12.007. Epub 2015 Dec 18.

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