Recothrom Thrombin Topical (Recombinant) 5000 IU Kit – Topical Coagulant

Recothrom is a recombinant human thrombin product (by Baxter) supplied as a sterile kit for topical hemostasis in surgery. It contains lyophilized thrombin powder that is reconstituted with saline before use. Recothrom is indicated to aid hemostasis in capillary/small-vessel bleeding when conventional methods (sutures, ligatures, cautery, etc.) are ineffective or impractical. It is approved for use in adults and pediatric patients ≥1 month old, and can be used with an absorbable gelatin sponge for added effectiveness. As a recombinant product, it contains no human- or animal-derived additives (reducing infection or allergy risk).

Kit Contents

Each 5,000-unit Recothrom kit includes all components needed to prepare and apply the thrombin solution:

• Thrombin vial: 5000 IU of sterile, lyophilized recombinant thrombin powder (single-use vial).
• Diluent syringe: 5 mL pre-filled with sterile 0.9% sodium chloride (saline).
• Transfer device: A sterile needle-free vial adapter (transfer device).
• Transfer syringe: A sterile 5 mL empty syringe for withdrawing the reconstituted solution.
• Syringe label: An adhesive label marked “For topical use only – DO NOT INJECT”.

All items are sterile and for single use. (For example, a product listing notes: “One single-use vial containing 5000 IU… one 5-mL prefilled diluent syringe, one sterile needle-free transfer device, one sterile 5-mL empty syringe, and one syringe label”.

Preparation and Administration

To prepare Recothrom, add the entire 5 mL saline diluent to the thrombin vial. This yields a 1000 IU/mL thrombin solution (5,000 IU in 5 mL) once fully dissolved. Gently swirl until the powder is completely dissolved. Withdraw the reconstituted solution into the transfer syringe.

Apply the Recothrom solution directly to the bleeding tissue. The official instructions state: “Apply RECOTHROM solution with absorbable gelatin sponge or RECOTHROM Spray Applicator Kit directly to the bleeding site surface”. In practice, the surgeon may pour or spray the solution onto a collagen/gelfoam sponge and press it onto the oozing tissue, or use a dedicated spray pump. The required volume depends on the size of the bleeding area. The solution remains active for up to 24 hours at room temperature after mixing, allowing flexibility during long procedures.

Indications

Recothrom is indicated for minor capillary or venule bleeding (oozing) during surgery. Specifically, it “aids 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”. It is used in a variety of surgical specialties (cardiac, vascular, orthopedic, general, etc.) whenever this level of bleeding control is needed. The product label notes it may be used in conjunction with an absorbable gelatin sponge (USP) to enhance clotting. (It is not intended for major arterial bleeds or use as an injection.)

Safety and Precautions

Topical use only – do not inject. Recothrom must never be injected intravenously. The labeling explicitly warns “For topical use only. DO NOT INJECT.”. Intravenous injection of thrombin can cause dangerous thrombosis if the product enters the bloodstream. Recothrom should not be used to control massive or brisk arterial bleeding; it is meant for low‐pressure oozing.

Allergies: Do not use in patients with a known hypersensitivity to Recothrom or any component of the kit, including hamster ovary cell proteins used in its manufacture. Hypersensitivity reactions (including anaphylaxis) have been reported.

Side effects: In clinical trials, the most common adverse events were thromboses or embolic events (up to ~6% incidence), reflecting the need for careful topical use. Formation of antibodies to Recothrom itself was very rare: <1% of patients developed antibodies, and none neutralized human thrombin. (This low immunogenicity is an advantage of the recombinant product – only ~1.5% on Recothrom developed antibodies vs. ~21.5% on bovine thrombin in one study.)

Additional Notes

Recothrom is supplied by prescription (Rx) and is one of Baxter’s adjunctive hemostatic agents. Because it is recombinant, it avoids animal/human plasma components, minimizing the risk of viral transmission or anti-bovine antibody reactions. Baxter reports that about 95% of Recothrom-treated surgical sites reached hemostasis within 10 minutes (comparable to bovine thrombin), demonstrating its efficacy for stopping minor bleeding quickly.