[CG] Tranexamic acid guideline

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Objectives

Intravenous Tranexamic Acid – Guidance for use in post partum haemorrhage

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Tranexamic acid exerts an anti-fibrinolytic effect through the inhibition of plasmin. It can be used to prevent bleeding or treat bleeding associated with excessive fibrinolysis.

Indications relating to obstetrics (RCOG guideline no. 52)1

Prevention – “Clinicians should consider the use of intravenous Tranexamic acid (0.5–1.0 g), in addition to oxytocin, at caesarean section to reduce blood loss in women at increased risk of PPH.”

Treatment – “Consideration should be given to the use of Tranexamic acid in the management of PPH.”

  • The RCOG guidance above predates the results of the WOMAN study.2
  • Following the results of this trial, Tranexamic acid may be considered after blood loss of ≥ 1000ml during caesarean section or vaginal delivery (or if haemodynamically unstable).
  • Tranexamic acid 1g should be administered if bleeding is ≥ 1500ml.
  • If bleeding continues after 30 min or stops and restarts within 24 hours of the first dose, a second dose of 1 g of Tranexamic acid can be given.
  • Tranexamic Acid is just one part of PPH management 
  • Surgical source control and haemostasis, Early resuscitation, involvement of senior staff and management of coagulopathy remain the most important interventions

Formulation

  • Tranexamic acid 100mg/ml. Clear, colourless fluid for injection supplied as a glass ampoule of 1 g Tranexamic acid in 10ml.

Administration3,4

  • 1 g in 10 mls (100 mg/mL) of Tranexamic acid given intravenously at an approximate rate of 1 mL per min (ie over 10 minutes). This should be given within 3 hours of the start of PPH.
  • If bleeding continues after 30 minutes or stops and restarts within 24 hours of the first dose, a second dose of 1 g Tranexamic Acid may be given. Administer as an infusion of 1 g Tranexamic acid diluted to 100ml with 0.9% sodium chloride (10mg/ml) over 8 hours or until the bleeding stops (unlicensed).

  • Tranexamic acid should not be mixed with blood for transfusion or any intravenous penicillin preparations including CoAmoxiclav.

Renal impairment5

The use of Tranexamic acid is contraindicated in patients with severe renal impairment.  For patients with mild to moderate renal impairment, the dosage of Tranexamic acid should be reduced according to the serum creatinine level:

Serum creatinine

 

Dose IV (BW = body weight)

Administration

μmol/l

mg/10 ml

120 to 249

1.35 to 2.82

10 mg/kg BW

Every 12 hours

250 to 500

2.82 to 5.65

10 mg/kg BW

Every 24 hours

> 500

> 5.65

5 mg/kg BW

Every 24 hours

 

Contraindications3,5,6

  • Active venous or arterial thrombosis
  • Hypersensitivity to Tranexamic acid
  • Fibrinolytic conditions following consumption coagulopathy, except in those with predominant activation of the fibrinolytic system with acute severe bleeding
  • Severe renal impairment - risk of accumulation
  • Patients with subarachnoid haemmorhage - may cause cerebral oedema / infarction
  • History of convulsions

Cautions3,5,6

  • Upper urinary tract bleeding - may cause ureteral obstruction due to clot formation)
  • Patients with a previous history of thromboembolic disease, thrombophilia or a strong family history of thromboembolism. Administer Tranexamic acid only if there is a strong indication (ie ongoing severe haemorrhage)
  • Tranexamic Acid Injection should not be administered concomitantly with Factor IX Complex concentrates or Anti-inhibitor Coagulant concentrates, as the risk of thrombosis may be increased.

Side effects3,5

  • Hypersensitivity reactions including anaphylaxis
  • Malaise and hypotension, with or without loss of consciousness, may be seen after rapid IV injection
  • Diarrhoea
  • Nausea and vomiting
  • Dermatitis
  • Impairment of colour vision – discontinue treatment if this occurs.
  • Seizures - Cases of convulsions have been reported in association with Tranexamic acid treatment. In coronary artery bypass graft (CABG) surgery, most of these cases were reported following IV injection of Tranexamic acid in high doses. With the use of the recommended lower doses of Tranexamic acid, the incidence of post-operative seizures was the same as that in untreated patients.

Breast feeding5

  • Small amount present in milk. Anti-fibrinolytic effect on infant unlikely
References
  1. Mavrides E, Allard S, Chandraharan E, Collins P, Green L, Hunt BJ, Riris S, Thomson AJ on behalf of the Royal College of Obstetricians and Gynaecologists. Prevention and management of postpartum haemorrhage. BJOG 2016;124:e106–e149  
  2. Shakur H et al. Effect of early tranexamic acid administration on mortality, hysterectomy, and other morbidities in women with post-partum haemorrhage (WOMAN): an international, randomised, double-blind, placebo-controlled trial. The Lancet 2017; 389(10084): 2105 – 2116
  3. FDA information - intravenous Tranexamic acid
  4. NHS GGC drug monographs: Tranexamic Acid. [Staffnet link] 
  5. Electronic Medicines Composium – Tranexamic acid
  6. BNF - Tranexamic acid.

 

Last reviewed: 18 January 2018

Next review: 31 January 2022

Author(s): Dr R Kearns

Approved By: Obstetric Governance Group