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Dear Readers! I started this blog when my daughter was in the NICU. She had ventriculitis. Her CSF report grew E.coli. But, she was injected Teicoplanin directly into her brain. The doctors made two errors here:

Teicoplanin is for gram-positive bacteria only. It does not treat E.coli.
Teicoplanin is not for intraventricular use. The manufacturer strongly discourage injecting Teicoplanin into the brain.

My daughter bled into the brain. She lived for another two years and ultimately died.

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Fibrin Sealant Kit (Tisseel) - Uses, Dose, Side effects, MOA

A fibrin sealant kit, also known as a fibrin glue or tissue adhesive kit, is a medical product used in surgical procedures to assist in hemostasis (stopping bleeding) and wound sealing. It consists of two main components: fibrinogen and thrombin. When these components are mixed together, they react to form a fibrin clot, which mimics the final stage of the body's natural blood clotting process.

Fibrin Sealant Kit (Tisseel) is derived from human plasma that contains fibrinogen and thrombin, apart from other proteins. It is used during surgical procedures for sealing anastomosis and securing hemostasis.

Fibrin sealant kit Uses:

Colonic anastomosis sealing (Tisseel only):
- Adjunct to standard surgical techniques (such as suture and ligature) to prevent leakage from colonic anastomoses following the reversal of temporary colostomies
Facial rhytidectomy (Artiss only):
- Used to adhere to tissue flaps during facial rhytidectomy surgery (facelift)
Hemostasis, adjunct:
- Artiss:
  - Adjunct to hemostasis is not indicated.
- Evarrest, Evicel:
  - Adjunct to hemostasis for use in patients undergoing surgery when control of bleeding by conventional surgical techniques (such as ligature, suture, and cautery) is ineffective or impractical.
- Raplixa:
  - Adjunct to hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as ligature, suture, and cautery) is ineffective or impractical.
- TachoSil:
  - Adjunct to hemostasis for use with manual compression in adults and pediatric patients of 1 month and more than 1 month in cardiovascular and hepatic surgery when control of bleeding by standard surgical techniques (such as ligature, suture, or cautery) is ineffective or impractical
- Tisseel:
  - As an adjunct to hemostasis in adult and pediatric patients ≥1-month undergoing surgery when control of bleeding by conventional surgical techniques, including ligature, suture, and cautery, is ineffective or impractical.
  - Tisseel is effective in heparinized patients.
Skin graft adhesion (Artiss only):
- To adhere autologous skin grafts to surgically prepared wound beds resulting from burns in adults and pediatric patients of 1 year and more than 1 year.

Fibrin Sealant Kit Dose in adults

Fibrin Sealant Kit Dose in adults for Colonic anastomosis:

For connecting parts of the colon after surgery, we use a special glue called Tisseel. The amount we need depends on how big the area is that we're covering.

If we're covering a small area, like up to 8 centimeters with a tube, we need 2 milliliters of Tisseel.
If the area is a bit bigger, up to 16 centimeters with a tube, we need 4 milliliters of Tisseel.
And if it's even bigger, up to 40 centimeters with a tube, we need 10 milliliters of Tisseel.

We can either drip or spray the Tisseel on, making sure to cover the whole area thinly. This helps the parts stick together and heal properly.

Fibrin Sealant Kit as an adjunct for Hemostasis:

Evarrest:

If there's bleeding, we use patches to stop it.
Depending on how big the bleeding area is, we use a certain number of patches.
We shouldn't use more than four big patches or eight small patches.
If we need more, we overlap the edges of the new patch with the old one.
If a patch doesn't stick properly, we replace it with a new one.

Evicel:

We spray or drop this on the bleeding tissue. If the bleeding doesn't stop, we add more. For every 1 mm of thickness we want to cover:
- For a small area, we need 2 mL.
- For a medium area, we need 4 mL.
- For a big area, we need 10 mL.

Raplixa:

We use this with a sponge to stop bleeding during surgery. The amount we use depends on how big the area is:
- For a small area, we need 0.5 g.
- For a medium area, we need 1 g.
- For a big area, we need 2 g.

TachoSil:

This is only for bleeding on the heart or liver. We use patches to cover the bleeding area, but we can only use a certain number:
- For big patches, we can use up to 10.
- For medium patches, we can use up to 14.
- For small patches, we can use up to 42.

Tisseel:

We use this glue to seal wounds. Depending on how big the wound is, we need different amounts:
- For a small area, we need 2 mL.
- For a medium area, we need 4 mL.
- For a big area, we need 10 mL.

Fibrin Sealant Kit for Skin graft adherence:

In skin graft surgeries, we use a product called Artiss to help the graft adhere to the wound bed. We apply it by spraying it in a thin layer over the area where the skin graft will be placed. The amount of Artiss needed depends on the size of the area to be covered:

For a small area of approximately 100 square centimeters, we need 2 milliliters of Artiss.
For a medium-sized area of around 200 square centimeters, we require 4 milliliters.
For a larger area of about 500 square centimeters, we use 10 milliliters.

This ensures that the skin graft stays firmly attached to the wound bed, promoting proper healing. Remember, Artiss should only be applied topically and should not be injected into blood vessels.

Fibrin Sealant Kit Facial rhytidectomy (facelift) surgery:

In facelift surgery, we use a product called Artiss to help keep the skin flap in place. We spray it onto the area where the skin will be attached. The amount we use depends on how big that area is:

For a small area, about 100 square centimeters, we need 2 milliliters of Artiss.
For a medium-sized area, around 200 square centimeters, we need 4 milliliters.
For a larger area, approximately 500 square centimeters, we need 10 milliliters.

This helps ensure the skin flap stays in the right position during the surgery. Remember, we should only apply it on the skin surface, not inside any blood vessels.

Fibrin Sealant Kit Dose in Childrens

Fibrin Sealant Kit Dose in children for Hemostasis, adjunct:

For stopping bleeding in infants, children, and adolescents, we have different products available:

Evicel: We can spray or drop it onto the bleeding area in short bursts. The amount we use depends on how big the area is and the thickness we want to cover:
- For a small area, about 20 square centimeters, we need 2 milliliters.
- For a medium-sized area, around 40 square centimeters, we require 4 milliliters.
- For a larger area, approximately 100 square centimeters, we use 10 milliliters.
TachoSil: We apply patches to the surface of the bleeding tissue. The number of patches depends on the size of the bleeding area:
- For big patches, we can use up to 10.
- For medium patches, we can use up to 14.
- For small patches, we can use up to 42.
Tisseel: We determine the package size based on how big the area is that we're covering. We can apply it by dripping or spraying:
- For a small area with a spray, about 100 square centimeters, we need 2 milliliters.
- For a small area with a cannula, about 8 square centimeters, we need 2 milliliters.
- For a medium-sized area with a spray, around 200 square centimeters, we require 4 milliliters.
- For a medium-sized area with a cannula, around 16 square centimeters, we require 4 milliliters.
- For a larger area with a spray, approximately 500 square centimeters, we use 10 milliliters.
- For a larger area with a cannula, approximately 40 square centimeters, we use 10 milliliters.

These products help stop bleeding and promote healing in infants, children, and adolescents, but they should only be applied topically and not injected into blood vessels.

Fibrin Sealant Kit for Skin graft adherence: Topical:

For children aged 1 year and older, as well as adolescents, when applying skin grafts, we use a product called Artiss to help the graft adhere to the wound bed. Artiss is applied by spraying it in an even, thin layer over the area where the skin graft will be placed. The amount of Artiss needed depends on the size of the area to be covered:

For a graft fixation area of approximately 100 square centimeters, we require 2 milliliters of Artiss.
For a graft fixation area of around 200 square centimeters, we need 4 milliliters.
For a graft fixation area of about 500 square centimeters, we use 10 milliliters of Artiss.

This ensures proper adherence of the skin graft to the wound bed, promoting successful healing. Remember, Artiss should only be applied topically and should not be injected into blood vessels.

Pregnancy Risk Factor C (manufacturer dependent)

When it comes to the risk of pregnancy with certain medications (Pregnancy Risk Factor C), it depends on the manufacturer's information.
This rating means that there haven't been studies done on animals to see how the medication might affect pregnancy.
So, it's uncertain whether it's safe or not for pregnant women, and the decision to use it should be carefully considered with a doctor's guidance.

Fibrin sealant kit use during breastfeeding:

The presence of fibrin sealant in breast milk is uncertain.
According to the manufacturer, whether to continue or stop breastfeeding while using this therapy should consider the potential risk to the baby from exposure, the advantages of breastfeeding for the baby, and the benefits of treatment for the mother.

Dose in Kidney Disease:

The manufacturer's labeling does not include any adjustments to the dosage for individuals with renal impairment.

This means that the recommended dosage remains the same for people with kidney problems as it is for those with normal kidney function.

Dose in Liver disease:

The manufacturer's labeling does not offer any dosage adjustments for individuals with hepatic impairment.
This implies that the prescribed dosage remains consistent regardless of liver function.

The frequency may vary by product and patient age.

Common Side Effects of Tisseel (Fibrin Sealant Kit):

Cardiovascular:
- Hypertension
- Atrial Fibrillation
Gastrointestinal:
- Diarrhea
- Nausea
- Hematologic & Oncologic:
  - Anemia
Hepatic:
- Increased Serum Transaminases
Immunologic:
- Antibody Development
Respiratory:
- Pleural Effusion

Less Common Side Effects Of Fibrin Sealant Kit:

Cardiovascular:
- Thromboembolism
- Deep Vein Thrombosis
- Bradycardia
- Peripheral Edema
Dermatologic:
- Pruritus
Immunologic:
- Graft Complications
Infection:
- Localized Infection
Miscellaneous:
- Fever
- Procedural Complications
- Postoperative Complication

Uncommon Side effects of Tisseel (Fibrin Sealant Kit):

Hematologic & Oncologic:
- Hematoma
- Decreased Hemoglobin
Infection:
- Staphylococcal Infection
- Abscess (Abdomen)
Local:
- Incision Site Hemorrhage

Contraindications to Tisseel (Fibrin Sealant Kit):

Artiss: Do not use if there's hypersensitivity to aprotinin or any component of the formulation, including proteins like fibrinogen, thrombin, and human albumin. Also, avoid injection directly into the circulatory system or highly vascularized tissue, and refrain from using it where the minimum recommended distance from the applicator tip to the target site cannot be assured.
Evarrest: Avoid use in cases of anaphylactic or severe systemic reactions to human blood products, intravascular application, or treatment of bleeding from large defects in visible arteries or veins.
Evicel: Do not use if there's a history of anaphylactic or severe systemic reactions to human blood products, severe or brisk arterial bleeding, direct intravascular injection, or when spraying in endoscopic or laparoscopic procedures where the minimum recommended distance from the applicator tip to the target site cannot be assured.
Raplixa: Contraindicated in cases of anaphylactic or severe systemic reactions to human blood products, intravascular application, or treatment of severe or brisk arterial bleeding.
TachoSil: Avoid use in cases of anaphylactic or severe systemic reactions to human blood products or horse protein, as well as intravascular application.
Tisseel: Contraindicated in cases of hypersensitivity to aprotinin or any component of the formulation, direct intravascular injection, severe or brisk arterial or venous bleeding, and application where the minimum recommended distance from the applicator tip to the target site cannot be assured.

These contraindications are crucial to consider to ensure safe and effective use of these products in medical procedures.

Warnings and precautions

Plasma from humans:

Fibrin sealant products are derived from human plasma, and there is a theoretical risk of disease transmission, including viral infections such as hepatitis or HIV, as well as variant Creutzfeldt-Jakob disease (vCJD) and Creutzfeldt-Jakob disease (CJD).
It's important to note that these risks are potential and not guaranteed.
However, any suspected infection transmitted by a product should be reported to the manufacturer promptly.
This ensures that appropriate investigation and measures can be taken to mitigate risks and ensure the safety of patients.

Hypersensitivity

Cases of hypersensitivity or allergic/anaphylactoid reactions, which can potentially progress to severe anaphylaxis, have been reported with the use of these products, although rarely.
The risk of such reactions may increase with repetitive use or with prior systemic administration of aprotinin.
If symptoms such as bradycardia, bronchospasm, dyspnea, erythema, flushing, hypotension, nausea, paresthesia, pruritus, tachycardia, urticaria, or wheezing occur, discontinuation of the product should be considered.
It's crucial to be vigilant for any signs of allergic reactions during the use of these products and to act promptly if such symptoms arise.

Monitoring parameters:

Monitoring during Spraying:

Blood Pressure: Keep an eye on changes in blood pressure.
Pulse: Monitor the pulse rate for any abnormalities.
Oxygen Saturation: Check oxygen levels in the blood regularly.
End-Tidal CO2: Monitor end-tidal CO2 levels, which indicate the amount of carbon dioxide at the end of exhalation.

Hypersensitivity Reactions:

Watch out for signs of hypersensitivity reactions.
Symptoms may include difficulty breathing, skin rash, rapid heartbeat, or swelling.
If any symptoms occur, stop using the product and seek medical attention immediately.

How to administer Tisseel (Fibrin Sealant Kit)?

Artiss:

Before using, ensure the application site is dry using standard techniques like compresses or swabs; do not use pressurized air or gas for drying.
Apply Artiss only to visible application sites using a painting motion from side to side in a thin layer.
Use Easy Spray and Spray set or an equivalent device cleared by FDA for application.
Do not use the Easy Spray and Spray set system in enclosed body cavities.
After spraying Artiss, immediately attach flap or skin graft; you have about 60 seconds for manipulation.
Hold the graft in position with gentle compression for at least 3 minutes; full adherence takes about 2 hours.
To prevent Artiss from adhering to gloves, wet them with saline before contact.
Use cannulas included with the application system for small wounds or edges of a skin graft.
Expel and discard the first several drops from the application cannula before use to ensure proper mixing.
Replace cannula if clogged; use provided spare piece if Y connector is clogged.

Evarrest:

For topical use only; apply to the surface of the bleeding site.
Remove excess blood or fluid from the site before application for better visibility.
Use the number of patches determined by the anatomic location and surface area of bleeding.
Cut patches to shape and size if needed, ensuring an overlap of about 0.5 to 1 inch.
Apply continuous manual compression for 3 minutes using dry or moist laparotomy pads or surgical gauze.

Evicel:

For topical use only; apply to the surface of bleeding tissue.
Dry surface areas of wound and remove excess blood by standard techniques before application.
Apply solution using drip method by keeping the tip of the applicator close to the tissue surface.
Control coverage area by varying applied force on plunger and tip distance from tissue.
Apply solution using spray or drip methods in short bursts for an even, thin layer.
Use provided air tube for spray application, maintaining a proper distance from tissue surface.

Raplixa:

For topical use only; apply directly to the bleeding site.
Sprinkle a thin layer of powder onto the bleeding site or pre-wetted gelatin sponge.
Apply gentle pressure with gelatin sponge using sterile gauze.

TachoSil:

Apply the yellow, active side directly to the bleeding tissue, extending 1 to 2 cm beyond margins of wound.
Hold in place with gentle compression through moistened gloves or pad for at least 3 minutes.
Prevent inactive side of patch from adhering to pad or gloves by placing a clean surgical instrument at one end prior to relieving pressure.

Tisseel:

Apply in thin layers by dripping or spraying using a cannula or spray set.
Hold sealed parts in desired position for 3 to 5 minutes after application.
Wet gloves or surgical instruments with saline to prevent sealant from adhering.
Expel and discard the first several drops from the application cannula before use.
Replace cannula if clogged; use provided spare piece if Y connector is clogged.

Mechanism of action of Tisseel (Fibrin Sealant Kit):

The formation of a biodegradable adhesive mimics the final step of the coagulation cascade, where fibrin is created from fibrinogen.
Fibrinogen is the key component of the adhesive solution.
This solution also includes thrombin, which converts fibrinogen into fibrin, and a fibrinolysis inhibitor (aprotinin), which prevents premature fibrin degradation.
When combined as instructed, a thick solution forms, which then solidifies into an elastic clot.
Patches, containing fibrinogen and thrombin, hydrate upon contact with bleeding surfaces, producing active fibrin and ultimately forming a fibrin clot.

Onset of Action for Full Adherence:

Artiss: Approximately 2 hours for full adherence.

Time to Hemostasis:

Evarrest: 4 minutes.
Evicel: 4 to 10 minutes.
Raplixa: 5 minutes.
TachoSil: 3 to 6 minutes.
Tisseel: 5 minutes.

International Brand Names of Fibrin sealant kit:

TachoSil
Tisseel
Tisseel Duo 500
Tisseel VH S/D
Artiss
Evarrest
Evicel
Raplixa

Fibrin sealant kit Brand Names in Pakistan:

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