Fibrin glue

Source: Wikipedia, the free encyclopedia.

Fibrin glue
Coagulation factor
Clinical data
Trade namesArtiss, Evicel, Tisseel, others
AHFS/Drugs.comProfessional Drug Facts
License data
Pregnancy
category
Topical
ATC code
Legal status
Legal status
Identifiers
CAS Number
DrugBank
UNII

Fibrin glue (also called fibrin sealant) is a surgical formulation used to create a

clot for hemostasis, cartilage repair surgeries or wound healing. It contains separately packaged human fibrinogen and human thrombin.[8][9][10][11][12][13][14][15][16][17]

Medical uses

This

glue is used as a supportive treatment in surgery (such as liver surgery) for the improvement of hemostasis where standard surgical techniques are insufficient or impractical.[18][19]

It is also used for repairing

skin graft donor site wounds to reduce postoperative pain.[23]

It can also be used to treat

pilonidal sinus disease but it is of unclear benefit as of 2017, due to insufficient research.[24]

Contraindications

The glue must not get into blood vessels, as this could lead to clotting in the form of thromboembolism or disseminated intravascular coagulation, or to anaphylaxis (a severe allergic reaction).[25]

Side effects

Possible adverse effects include

urticaria, angioedema, bronchospasm, and anaphylaxis. Other adverse effects in studies occurred in roughly equal proportions in treatment and placebo groups.[25]

Interactions

As fibrin glue contains proteins, it may be denatured by ethanol, iodine and heavy metals. These substances are frequently found in antiseptic solutions.[25]

Pharmacology

Mechanism of action

Thrombin is an enzyme that splits fibrinogen into fibrin monomers in 10 to 60 seconds, which aggregate to form a three-dimensional gel-like structure. Thrombin also activates factor XIII from the human body to factor XIIIa, which then cross-links the fibrin monomers to form a stable clot. Both these processes need calcium to work. As the wound heals, the clot is slowly degraded by the enzyme plasmin.[16][25][26]

Pharmacokinetics

In rabbit studies, only 1 to 2% of the applied thrombin dose reached the bloodstream. It reached highest blood plasma concentrations after 6 to 8 hours.[25]

Chemistry

Composition

Fibrin glue comes in two vials, respectively containing:

  • fibrinogen:
    lyophilised
    pooled human concentrate
  • thrombin: This used to be of
    bovine origin; modern formulations contain human thrombin.[11]

The two components are mixed immediately before application.[18][27] The formulations also contain calcium salts.[25]

Formulations from different manufacturers may also contain

plasminogen, and factor XIII.[28][29]

Factors affecting structure

Factors that influence dimensional structure of fibrin gel giving rise to fine or coarse gel:

History

A formulation with human thrombin was approved for medical use in the United States in March 2003, and in the European Union in October 2008.[18][27][30]

References

  1. ^ a b "VeraSeal". Therapeutic Goods Administration (TGA). 12 November 2021. Retrieved 28 December 2021.
  2. ^ "Updates to the Prescribing Medicines in Pregnancy database". Therapeutic Goods Administration (TGA). 12 May 2022. Retrieved 13 May 2022.
  3. ^ "AusPAR: Human Fibrinogen / Human Thrombin". Therapeutic Goods Administration (TGA). 29 June 2022. Retrieved 17 July 2022.
  4. ^ "Health product highlights 2021: Annexes of products approved in 2021". Health Canada. 3 August 2022. Retrieved 25 March 2024.
  5. ^ "TachoSil sealant matrix - Summary of Product Characteristics (SmPC)". (emc). 31 January 2020. Archived from the original on 10 July 2020. Retrieved 10 July 2020.
  6. ^ "Tisseel Ready to use Solutions for Sealant - Summary of Product Characteristics (SmPC)". (emc). 30 December 2019. Retrieved 10 July 2020.
  7. ^ "Artiss Solutions for Sealant - Summary of Product Characteristics (SmPC)". (emc). 29 January 2019. Retrieved 10 July 2020.
  8. PMID 31703078
    .
  9. PMID 24579215
    .
  10. S2CID 248208731
    .
  11. ^
    PMID 8173397
    .
  12. S2CID 37017252
    .
  13. ^ "Fibrin Glue for Anal Fistula - Digestive Disorders / Gastroenterology". MedHelp.
  14. S2CID 46792418
    .
  15. PMID 2440358
    .
  16. ^ a b c Saxena S, Jain P, Shukla J (2003). "Preparation of two component Fibrin Glue and its clinical evaluation in skin grafts and flaps". Indian J Plast Surg. 36 (1): 14–17.
  17. S2CID 31854904
    .
  18. ^ a b c "Evicel EPAR". European Medicines Agency. 17 September 2018. Retrieved 12 June 2020. Public Domain This article incorporates text from this source, which is in the public domain.
  19. ^ "Evicel Fibrin Sealant (Human)". U.S. Food and Drug Administration (FDA). 22 July 2017.
  20. PMID 17379570
    .
  21. PMID 19668958
    .
  22. ^ "Fibrin Sealant Fibrin Gluing Haemostasis autologous". vivostat.com.
  23. S2CID 44520644
    .
  24. PMID 28085995
    .
  25. ^ a b c d e f "Evicel: EPAR – Product Information" (PDF). European Medicines Agency. 12 June 2020.
  26. S2CID 20760524
    .
  27. ^ a b "Evicel Fibrin Sealant (Human)- fibrinogen human and thrombin human kit". DailyMed. 17 December 2019. Retrieved 12 June 2020.
  28. ^ "Tisseel". Swedish official drug catalog.
  29. ^ KEGG drug: Factor XIII with fibrinogen. Accessed 9 July 2020.
  30. ^ "Evicel". U.S. Food and Drug Administration (FDA). 5 June 2017. Archived from the original on 22 July 2017. Retrieved 12 June 2020.
Retrieved from "https://en.wikipedia.org/w/index.php?title=Fibrin_glue&oldid=1218288205"