Topical Thrombin (Evithrom, Recothrom, Thrombi-Gel)

Topical thrombin activates platelets and catalyzes the conversion of fibrinogen to fibrin to promote hemostasis.

Evithrom, Recothrom, Thrombin-JMI only:
- It is used as an aid whenever blood oozes out of minor capillaries and small venules which are accessible and control of bleeding by standard surgical techniques is noneffective or impractical.
Thrombi-Gel, Thrombi-Pad only:
- It is used as a trauma dressing for temporary control of moderate to severe bleeding wounds
- It is used for control of surface bleeding from vascular access sites and percutaneous catheters and tubes.

Topical Thrombin Dose in Adults

Dose in the treatment of Hemostasis aid:

Do not administer intravenously or intraarterially:
Evithrom:
- The dosage depends on the area to be treated
- for direct application, flood treatment area; up to 10 mL was done with absorbable gelatin sponge in clinical studies.
Recothrom:
- The dosage depends on the area to be treated.
- It is applied to the bleeding site directly or in conjunction with an absorbable gelatin sponge.
Thrombi-Gel:
- It is applied directly over source of the bleeding with adjunct manual pressure until hemostasis is achieved.
Thrombin-JMI:
- Solution:
  - It is applied 1,000 to 2,000 units/mL of solution where bleeding is profuse.
  - Apply 100 units/mL for skin or mucosal bleeds (eg, skin grafting, dental extractions, plastic surgery).
- Powder:
  - The dry powder can be directly applied to the site on oozing surfaces.
Thrombi-Pad:
- The dry or wetted pad is applied directly over the source of bleeding with adjunct manual pressure.
- If needed, the product may be left in place for up to 24 hours; do not leave in the body.

Topical Thrombin Dose in Adults

Dose in the treatment of Hemostasis:

Evithrom:
- Infants, Children, and Adolescents:
  - The dosage depends on the area to be treated
  - It may be applied directly or in conjunction with an absorbable gelatin sponge; up to 10 mL was used with absorbable gelatin sponge in clinical studies
- Recothrom:
  - Infants ≥1 month, Children, and Adolescents:
    - The dosage depends on the area to be treated including the size of and number of bleeding sites; may apply directly or in conjunction with an absorbable gelatin sponge

Pregnancy Risk Factor C

Studies on animal reproduction have not been conducted.
Animals suffered adverse reactions in reproduction studies that were done using the solvent/detergent used to process the human-derived product Evithrom.

Thrombin use during breastfeeding:

It is unknown if breast milk contains thrombin topical or not.
Manufacturer recommends caution when giving thrombin topical breastfeeding women.

Topical thrombin dose in kidney disease:

There are no dosage adjustments given in the manufacturer's labeling.

Topical thrombin dose in liver disease:

There are no dosage adjustments given in the manufacturer's labeling.

Side effects of topical thrombin:

Cardiovascular:
- Thromboembolism
Dermatologic:
- Pruritus
Gastrointestinal:
- Nausea
- Vomiting
Hematologic & oncologic:
- Increased INR
- Increased neutrophils
- Lymphocytopenia
- Prolonged partial thromboplastin time
- Prolonged prothrombin time
Hypersensitivity:
- Hypersensitivity reaction
Immunologic:
- Antibody development
Local:
- Postoperative wound complication

Contraindication to Topical Thrombin Include:

Hypersensitivity to any component of the formulation.

Evithrom:

Anaphylactic and severe systemic reactions have been reported to blood products
Treatment of severe or brisk blood vessel bleeding

Recothrom:

Hypersensitive to hamster protein
Inject directly into the circulatory tract
Treatment of severe or rapid arterial bleeding.

Thrombi Gel:

This is used to close skin incisions.

Thrombin-JMI:

It is sensitive to bovine-derived material.
Inject directly into the circulatory tract
Re-exposure is recommended if there are any suspected antibodies to bovine factor V and/or bovine thrombin.
treatment of severe or brisk arterial bleeding.

Thrombi Pad:

Iy is sensitive to bovine-derived substances.

Warnings and precautions

Hypersensitivity
- Hypersensitivity reactions, including anaphylaxis can occur.
- Individual symptoms can be treated immediately with supportive measures.
Plasma from human beings
- Elinchrom is made from human plasma
- It could also contain potential infectious agents that could spread infectious agents such as viruses or Creutzfeldt Jacob disease agent.
- The risk can be reduced by screening donors and testing for or inactivating certain viruses.
Infection risk:
- Thrombi Gel and Thrombi Pad:
- Avoid contact with infection.
Nonabsorbable product:
- Thrombi-Pad
- It should not be used as a substitute for absorbable hemostats.
- It is not absorbable so do not leave it in your body.
Proteins (snake, hamster origin)
- Recothrom
- Patients with known allergies to hamster or snake proteins should be cautious.
- The possibility of an allergic reaction is theoretically possible.
Severe bleeding and complications from thrombosis:
- Only Thrombin-JMI and Thrombi-Gel. [US Boxed Warning]
- The topical Thrombin (bovine), can cause severe bleeding or thrombosis.
- The development of antibodies against bovine blood thrombin can lead to thrombosis.
- The development of antibodies against factor VI could lead to bleeding.
- They can also cross-react to human factor V, resulting in its deficiency.
- If patients have been found to have antibodies to bovine factor V and/or bovine thrombin, do not re-expose them to thrombin topical.
- Assess patients for abnormal laboratory values in coagulation, bleeding, or thrombosis.

Monitor:

Signs of hypersensitivity
bleeding
thrombosis
abnormal coagulation laboratory values.

How to administer Topical Thrombin?

For topical use only
Do not give intravenously or intra-arterially.

Evithrom:

Sponge or suction target surface free of blood before application (do not wipe).
Use syringe and small-gauge needle to apply
avoid sponging the clot after applying.
Transfer solution to a sterile container and immerse gelatin sponge(s) into solution when using it in conjunction with absorbable gelatin sponge.
vigorously knead until all air is expelled and sponge returns to its original size and shape
Then hold the sponge in place with gauze or cotton pledget using moderate pressure until hemostasis is achieved.

Recothrom:

Apply the reconstituted solution directly using ZymoGenetics spray applicator kit or in combination with absorbable gelatin sponge.
When using spray applicator, use the sterile bowl in the kit as a receptacle for reconstituted solution
Then refer to the spray kit manufacturer’s labeling for spray pump and syringe spray assembly and use.
When it is used in conjunction with an absorbable gelatin sponge(s), transfer solution to a sterile container and immerse gelatin sponge(s) into the solution until completely saturated
Then gently squeeze to remove excess solution
apply the sponge to a bleeding site in a single layer.

Thrombi-Gel:

After wetting, place it directly over the bleeding source and apply adjunct manual compression until hemostasis is achieved
It may be cut or roll to the desired shape prior to wetting.

Thrombin-JMI:

Sponge (do not wipe) application surface before use, if possible.
Then apply as a dry powder or reconstituted solution.
flood surface by a sterile syringe with a small-gauge needle or use in conjunction with Thrombin-JMI pump spray kit, syringe spray kit, or epistaxis kit when used as a solution.
The 5,000 unit syringe spray kit might be used to saturate gelatin powder in Gel-Flow NT
The mixture can be smeared, filled or pressed against the surface to control bleeding.
When used in conjunction with absorbable gelatin sponge, immerse sponge strips into the solution
vigorously knead sponge with moistened gloved fingers until all air is expelled
Then apply the saturated sponge to the bleeding area
hold in place with gauze or cotton pledget by moderate pressure until hemostasis is achieved.
Product is most effective when it mixes freely with blood as soon as it reaches the surface.
Avoid sponging of treated surfaces.