Thrombin Human, Recombinant (Topical)

Following surgical procedures, Thrombin Human, Recombinant can be applied to incisions to control small amounts of bleeding and discharge.

Overview

Our body naturally produces the protein, Thrombin, in order to aid in healing and blood coagulation (blood clotting).

There is, however, a synthetically produced version of Thrombin that surgeons occasionally use to regulate mild bleeding and oozing.

Manufacturers use a genetically modified CHO cell line to create the synthetic version in labs. In the United States, this artificial Thrombin is known as Recothrom. This subset of Thrombin, in particular, may be derived from snake and hamster proteins.

How it Works

In essence, Thrombin Human, Recombinant stimulates blood platelets and puts in motion the transformation of fibrinogen to fibrin. Thrombin Human, Recombinant ultimately supports the blood clotting process within the human body.

Condition(s) treated

  • Minor Bleeding
  • Oozing
  • Hemorrhage

Type of medicine

  • Blood Coagulation Factor, Local Hemostatic

Side Effects

All medications carry side effects. Thrombin Human, Recombinant is no different.

The most widely reported side effects of using Thrombin Human, Recombinant include:

  • Blurred Vision
  • Disordered Coordination
  • Incoherent Speech
  • Sudden Headaches
  • Trouble Breathing
  • Upper and Lower Body Pain
  • Weakness in the Arm and Legs

Some of these side effects typically dissolve with time, however, it's always a good idea to tell your doctor if you develop any of the above side effects as these could be signs of Anaphylaxis shock.

Less Common Side Effects of Thrombin Human, Recombinant

There have been less reported incidences of the following side effects after taking Thrombin Human, Recombinant:

  • Burning Sensation
  • Flushing Skin
  • Itching
  •  Rashes
  • Skin Irritation

These in large part apply to irritation at the incision site.

Rare Side Effect of Thrombin Human, Recombinant

  • A rare side effect is antibody formation.

Dosage

When most people hear the word "topical”, a gel or cream often comes to mind. Thrombin Human, Recombinant, however, is classified as a Lyophilized Powder. It was approved by the FDA for mild hemorrhaging in 2008 and is intended for topical applications only. It should never be injected into the circulatory system as this could lead to thrombosis.

The determined dose is usually based on a number of variables including:

  • Age
  • BMI
  • Gender
  • Pre-Existing Medical Conditions

Types of Incisions

The powder form of Thrombin Human, Recombinant can be directly applied to customary surgical incisions, including:

  • Cautery Incisions
  • Ligatures
  • Sutures

Standard Doses

Thrombin Human, Recombinant is exclusively administered by trained healthcare workers in hospital, dental, or outpatient settings during or after surgery. The most standardized dosage used today range from:

Topical Powder and Spray Solutions

  • 5000 units (5 ml *** Includes Diluent with the Powder Form Thrombin Human, Recombinant.)
  • 20,000 Units (20 ml *** Includes Diluent with the Powder Form Thrombin Human, Recombinant.)

Important: The powder should never be injected into the incision or any other area of the body.

The extent of the bleeding will also play a role in the dosage given by medical providers. For example:

  • In Cases of Low to Medium-Level Bleeds: 100 units/ml is commonly used. Examples of these scenarios involving minor bleeds are patients who have undergone dental procedures, skin grafts, or plastic surgery, for example.
  • Oozing and Bleedings - 1000 - 2000 units/ml are generally given for larger tissue areas.

Best Application Methods

As a safety measure, healthcare workers will use a spray or sponge to apply the solution directly onto the incision. The FDA recommends using an absorbable gelatin sponge for best results.

Read the instructions on the sealed package carefully before completing the dose. The standard instructions for use include:

  1. Uncapping the Vial - Try keeping all of the contents of the medicine intact when removing the cap.
  2. Place in a Sterile Bowl - A clean and sterile basin can also be used.
  3. Mix With a Diluent If Applicable - Check with the surgeon to determine if this extra step should be completed.
  4. Gently Apply on Incision - Avoid using too much force when spraying or sponging the solution on patients. It should be dotted onto the incision with a sponge and never wiped or sprayed. Some healthcare providers prefer using an absorbable gelatin sponge to soak in the solution and transfer it to the incision site - gently and in one layer to avoid aggravating the incision.
  5. Wait Until the Powder Dissolves - It should dissolve into the incision within 60 seconds of application.
  6. Monitor Patients Closely - Check for any hypersensitivity reactions to the medicine at different intervals after use. The most common concern is an anaphylactic shock.
  7. Safely Discard the Empty Container - As an added layer of security, a pre-printed "DO NOT INJECT"sign is usually placed on the empty vial before discarding.

Interactions

Your surgeon should be aware of any medications you may be taking, including any over-the-counter drugs.

It is also vital that you discuss any lifestyle habits that could negatively interact or affect the outcome of using Thrombin Human, Recombinant. Some examples include telling your doctor if you happen to smoke tobacco or are a habitual drinker.

Warnings

As Thrombin Human, Recombinant is derived from protein, it's important to tell your doctor before surgery if you have ever had any allergic reactions to animal products, especially hamster or snake proteins.

Thrombin Human Recombinant may cause Anaphylaxis, which is considered to be a fatal condition if it's not treated in a timely manner.

Some of the most common telltale signs of Anaphylaxis include:

  • Coughing or Trouble Breathing or Swallowing
  • Feeling Faint or Lightheaded
  • Feeling Too Warm or Too Cold
  • Itching and Hives
  • Puffed Up Face, Hands, Throat, or Tongue
  • Sudden Tightness in the Chest

If any of these symptoms develop after taking Thrombin Human, Recombinant, inform your nurse and/or doctor on duty immediately. Most healthcare facilities are equipped with an emergency dialer close to patients' beds and inside bathrooms for these very purposes.

Any other past allergic reactions should be noted in your medical history, and in particular, any sensitivities to any other foods, dyes, and preservatives.

Certain underlying medical conditions may also affect the way Thrombin Human, Recombinant works. The most widely studied negative interaction with Thrombin and an underlying condition is the presence of significant bleeds.

Thrombin Human, Recombinant is a class of drug that is approved for minor bleeds only. It should never be used to stop major bleeds, otherwise known as brisk arterial bleeding.

Adults and children who have been given Thrombin Human, Recombinant should be watched closely after administration for any negative side effects that could develop. Some side effects that require immediate medical attention include:

  • A Major Headache
  • Blurred Vision
  • Chest Pain
  • Lethargy
  • Numbness
  • Respiratory Issues
  • Swelling
  • Trouble Speaking

Other Precautions

There have been no archives of adverse effects when Thrombin Human, Recombinant is used in senior or minors, except infants younger than four weeks old.

For nursing or expecting mothers, no sufficient research has been conducted to determine benefits vs. risks. Medical workers should therefore weigh both variables before coming to an assumption on the best course of treatment for patients.

Before administering the prescribed dosage, healthcare workers should always examine the package. If there are any signs of tampering, do not use. The vial should be handled with clean and dry hands, and as a standard practice, always wear medical-grade gloves when administering the medicine to patients to prevent the risk of transmission of infectious diseases.

Storage

The best practices for storing medicines at home, including topical products, is in cool and dry areas.

Thrombin Human, Recombinant is recommended for single and immediate use only. However, it can be refrigerated for up to 3 hours after opening in temperatures ranging from 2-8 degrees Celsius. Ask an authoritative figure if you are unsure of how to properly store the medicine.

Summary

Thrombin Human, Recombinant treats minor hemorrhaging during surgery. It therefore falls in the class of drugs known as surgical hemostats.

The human body produces thrombin naturally, and it is considered a critical protein for blood clotting purposes. After surgery, however, some patients may need a boost to speed up the healing process, and this is where synthetically derived Thrombin Human, Recombinant comes in.

Generally, the manmade version is sourced from snake and hamster proteins, and for this reason, it is critical to inform surgeons of any past allergic reactions to animal products as well as dyes or preservatives.

The most common concerns when taking Thrombin Human, Recombinant is hypersensitivity reactions or anaphylactic shock, as it is a synthetically produced protein.

Both children and adult patients should be closely monitored after administering the topical medicine to the incision, especially those who have had any history of allergies.

Due to allergic risks, doctors will weigh patients' full medical history before prescribing the drug.

Generally speaking, however, using Thrombin Human, Recombinant has been proven to successfully treat minor bleeds as it promotes the speedy coagulation of blood. It should only be administered by a trained health professional and should never be injected into the circulatory system.