Hemostasis

Hemostasis is a complex process that prevents or terminates blood loss from disrupted vessels, provides a fibrin network for tissue repair and then removes fibrin when it is no longer needed. Four major physiologic events participate in the hemostatic process after a vessel injury:

1. Vasconstriction—Damaged blood vessel immediately contracts to narrow diameter and decrease blood loss.

2. Platelet plug formation—Platelets make contact with and adhere to the damaged endothelium. Platelets begin increasing in size, spreading out and aggregating to form a plug.

3. Fibrin Clot formation—Thrombin acts upon soluble fibrinogen in the blood to form insoluble fibrin monomers which then polymerize and crosslink to form a mesh to entrap cells and anchor to tissue.

4. Fibrinolysis—Endothelial cells begin to secrete plasminogen, the precursor of plasmin, which breaks up fibrin clots as the structural integrity of the blood vessel wall is restored.

In surgery, the success of a procedure can often depend upon a surgeon's ability to efficiently and effectively control blood loss. In situations where the control of bleeding by standard surgical techniques is ineffective or impractical, Ethicon™ Biosurgery offers a variety of hemostatic products including: EVICEL^® Fibrin Sealant (Human), SURGIFLO^® Hemostatic Matrix, EVITHROM^® Thrombin, Topical (Human), SURGIFOAM^® Family of Products and SURGICEL^® Family of Absorbable Hemostats.

Ethicon supplies a wide range of high-performing needles and absorbable and non-absorbable sutures available in a variety of materials. Antibacterial Plus sutures and DERMABOND^® Topical Skin Adhesive for surgical incisions are also available.

Indication

EVITHROM^® is a topical thrombin indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. EVITHROM^® may be used in conjunction with an Absorbable Gelatin Sponge, USP.¹

Important Safety Information

For topical use only. Do not inject EVITHROM^® directly into the circulatory system.

Do not use for the treatment of severe or brisk arterial bleeding.

Do not use in individuals known to have anaphylactic or severe systemic reaction to human blood products.

Because this product is made from human plasma, it may carry a risk of transmitting infectious agents, such as viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

There is a potential risk of thrombosis if absorbed systemically.¹

Anaphylactic reactions may occur.

The most common adverse reactions during clinical trial (reported in at least 2% of subjects treated with EVITHROM^®) were prolonged activated partial thromboplastin time, increased INR, decreased lymphocyte count, prolonged prothrombin time and increased neutrophil count. Adverse events were reported in the clinical trial with similar frequency in the two study groups (EVITHROM^® or bovine thrombin group) ¹

References:
1. EVITHROM^® Thrombin, Topical (Human) Full Prescribing Information.

Indication:

EVICEL® Fibrin Sealant (Human) is indicated as an adjunct to hemostasis for use in patients undergoing surgery, when control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical.

Important Safety Information:

For topical use only. Do not inject directly into the circulatory system.

Not indicated for the treatment of severe or brisk arterial bleeding.

Do not use in individuals known to have anaphylactic or severe systemic reaction to human blood products.

Air or gas embolism has occurred with the use of spray devices employing pressure regulator to administer fibrin sealants. These events appear to be related to the use of the spray device at higher than recommended pressures and in close proximity to the surface of the tissue. Follow labeled application instructions regarding pressure range and distance when using a spray device and monitor patients for the possibility of air or gas embolism.

Because this product is made from human plasma it may carry a risk of transmitting infectious agents, such as viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

Anaphylactic reactions may occur.

Most common adverse events reported in clinical trials (≥5%) are bradycardia, nausea, hypokalemia, insomnia, hypotension, pyrexia, graft infection, vascular graft occlusion, oedema peripheral, constipation.

See sales representative for Full Prescribing Information

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