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Fibrinogen Concentrate

Aka. RiaSTAP or Fibrinogen (Factor I) Concentrate

DESCRIPTION

  • Concentrated human factor I (fibrinogen)

INDICATIONS

  1. Congenital or acquired hypo- or afibrinogenaemia
  2. In a bleeding patient, with fibrinogen level less than 1.5 g/L (2.0 g/L in obstetric haemorrhage or cardiothoracic haemorrhage)
  3. Because the ROTEM/TEG algorithm told you to give it

ADMINISTRATION / DOSING

  • Intravenous (IV)
  • Adults:
    • Generally: 2-4 g (2-4 vials) for average-sized adult
    • If fibrinogen level unknown, administer 70 mg/kg
    • Dosing suggested by manufacturer:
      • mg/kg = [(Target fibrinogen level g/L) – (Actual fibrinogen level g/L)] ÷ 0.017
      • E.g. mg/kg = [2.2 g/L – 1.0 g/L) ÷ 0.017 = 70 mg/kg –> x 75 kg = ~5.3 g
  • Children:
    • No manufacturer guidelines however;
    • Suggestion of 30-60 mg/kg and consultation with your relevant haematology service
  • Administration:
    • Manufacturer recommends 5 mL/min, and other guidelines recommend 20 mL/min (i.e. slow push over 2.5mins)
    • Can be administered peripherally as with all other blood products
    • Not compatible with any other blood products nor other medications
    • Flush with saline
    • Tips on how to reconstitute are below

PREPARATION

  • Manufactured from cryoprecipitate into a glycine precipitate, then filtered further with multiple precipitation/adsorption steps
  • It is heat treated (+60oC for 20 hours in aqueous solution)
  • 2x subsequent glycine precipitation steps
  • Finally, it is lipophilised (aka. freeze-dried, or cryodesiccated)

PHARMACEUTICS

  • Presentation:
    • Single-dose glass vial with 1 g of human fibrinogen and a rubber stopper (latex free)
    • One glass vial of 50 mL water for injection
    • One transfer set
    • One dispensing pin
    • One syringe filter
  • Contents:
    • 900-1300 mg of human fibrinogen (1 g)
  • Excipients:
    • Albumin (400-700 mg)Arginine hydrochloride (375-660 mg)Sodium hydroxide (for pH adjustment)Sodium chloride (200-350 mg, or ~7.1 mmol per vial)
    • Sodium citrate (50-100 mg).
  • Storage:
    • Temperatures of 2-8oC and is stable for up to 60 months
    • Must be used within 8 hours after reconstituted

GROUP / CROSSMATCH

  • Not required

ADVERSE EFFECTS

  • Thromboembolic episodes including MI, PE, DVT and arterial thrombosis
  • Allergic reaction: anaphylaxis, dyspnoea, rash
  • Chills, nausea, vomiting
  • Risk of infectious disease transmission such as: CJD, HIV, Hep B and C

LOCATION OF ACTION

MECHANISM OF ACTION

  • Fibrinogen (factor I) in the presence of thrombin (factor IIa) and factor XIIIa (fibrin-stabilising factor) and calcium ions is converted into a stable and elastic three-dimensional fibrin (factor Ia) haemostatic clot

CONTRAINDICATIONS

  • Known hypersensitivity / anaphylaxis reactions to this product or other concentrated fractionated plasma products

ADVANTAGES AND DISADVANTAGES TO CRYOPRECIPITATE

Advantages

  • Does not need to be thawed and so can reduce the time it takes to administer fibrinogen replacement
  • No grouping / crossmatch required
  • Much more convenient to give a large amount of fibrinogen in a relatively small volume
    • (e.g. to give 1 g of fibrinogen in cryoprecipitate it would take ~3 units (= ~100 mL), or for FFP you would require ~2 units for 1 g = ~600 mL volume)
      • At Institution 1 (a quaternary hospital with ~600 beds in Sydney) there are only 80 units of O and A each, 70 of B and 30 of AB cryoprecipitate at any one time
  • Useful in pre-hospital or regional settings where blood product storage is limited
  • Long shelf-life of 60 months (vs 12 months for cryoprecipitate)

Disadvantages

  • Costly, roughly double the cost of cryoprecipitate (AUD$863.12 per 1 g RiaSTAP vs AUD$163.01 per unit of cryo)
  • Lack of familiarity

RECONSTITUTION TIPS

It is a bit of a PITA (pain in the ass) to reconstitute, DO NOT shake when the water for injection has been added, otherwise you will end up with a foamy mess (like teicoplanin, you only ever do it once)

  • You will need, in addition to the package contents, a 50-60 mL luer-lock syringe, and a sterile alcohol wipe (or equivalent)
  • You will also need a decent amount of bench space if you are reconstituting more than 1 g

CCC Transfusion Series

Blood Products

Cryoprecipitate, Fresh Frozen Plasma (FFP), PlateletsRed Cells (RBCs)

Concentrates: Prothrombinex, Factor VIIa, Fibrinogen Concentrate

Reversal

Rivaroxaban / Apixaban / Enoxaparin: Andexanet Alfa, Rivaroxaban and Bleeding

DabigatranIdarucuzimabDabigatran and bleeding

HeparinProtamine

WarfarinVitamin K / FFP / PTx, Warfarin Reversal, Warfarin Toxicity

Testing

Coagulation StudiesTEG / ROTEM (Thromboelastography)Platelet function assays

General Topics

Acute Coagulopathy of TraumaBlood BankBlood conservation strategiesBlood Product Compatibilities, Blood transfusion risksDisseminated Intravascular CoagulationMassive blood lossMassive transfusion protocol (MTP)Modifications to blood components,Procedures and CoagulopathyStorage LesionsTRALITransfusion Literature Summaries, Transfusion Reactions

References

  • Albert Health Services. (2021, September 01). RIASTAP™ Fibrinogen Concentrate (human). Retrieved January 13, 2023, from https://www.albertahealthservices.ca/assets/wf/lab/if-lab-clin-tm-riastap.pdf
  • CSLBehring. (2021, June). Prescribing Information for RiaSTAP. Retrieved January 17, 2023, from http://cslbehring.vo.llnwd.net/o33/u/central/PI/US/RiaSTAP/EN/RiaSTAP-Prescribing-Information.pdf
  • CSL Behring. (2021, June 1). Reconstitution of RiaSTAP. Retrieved January 17, 2023, from https://riastap.healthydigital.net/sites/default/files/pdf/RiastapReconGuide_v5_03.pdf
  • D, J. (2007, April 22). File:coagulation full.svg. Retrieved January 17, 2023, from https://commons.wikimedia.org/wiki/File:Coagulation_full.svg
  • National Blood Authority Australia. (2023, January 01). What blood products are supplied – national product price list. Retrieved January 18, 2023, from https://www.blood.gov.au/national-product-price-list

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CCC 700 6

Critical Care

Compendium

ICU Advanced Trainee BMedSci [UoN], BMed [UoN], MMed(CritCare) [USyd] from a broadacre farm who found himself in a quaternary metropolitan ICU. Always trying to make medical education more interesting and appropriately targeted; pre-hospital and retrieval curious; passionate about equitable access to healthcare; looking forward to a future life in regional Australia. Student of LITFL.

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