EXACYL 0,5 G/5 ML I.V. (acide tranexamique) (prévention et traitement des hémorragies)

Key points

Favourable opinion for reimbursement in the prevention and treatment of haemorrhages due to general or local fibrinolysis in adults and children from one year:

• Gynaecological surgery or disorders of obstetric origin,
• Thoracic and abdominal surgery and other major surgical intervention such as cardiovascular surgery

What therapeutic improvement?

No clinical added value in the therapeutic strategy.

Role in the care pathway?

The prevention of perioperative bleeding is based on the identification and correction of pre-existing risk factors (haemostasis disorders with a bleeding risk, preoperative management of antithrombotic treatments), and the prevention of the onset or exacerbation of a coagulation disorder (correction of promoting factors such as hypothermia or severe acidosis, and in some cases, administration of prohaemostatic agents).

In the event of haemorrhage, the therapeutic approach (except in surgical or obstetric procedures) is compensation therapy (transfusion) and reduction of the amplitude of the phenomenon (administration of clotting factors, inhibition of fibrinolysis).

In addition to any surgical or obstetric procedures and strategies to compensate for or replace components that are consumed, a few medicinal products are currently authorised and recommended in the prevention and management of haemorrhage in a context of gynaecological surgery, obstetric problems or major surgery:

• uterotonic treatments (oxytocin, sulprostone, carbetocin) in the prevention and/or treatment of postpartum haemorrhage
• aprotinin, as prophylaxis, in adult patients who are at high risk of major blood loss undergoing isolated cardiopulmonary bypass graft surgery,
• tranexamic acid, recommended in the perioperative context for haemorrhagic surgery, and the use of which is suggested by certain guidelines in the treatment or prevention of postpartum haemorrhage.

The benefit of therapeutic intervention in these fields can be assessed based on the volume of bleeding, the transfusion volume, morbidity and mortality.

Role of EXACYL (tranexamic acid) 0.5 g/5 mL I.V. solution for injection in the care pathway for the prevention and treatment of haemorrhages due to general or local fibrinolysis in adults and children from one year

In gynaecological, thoracic and abdominal surgery and other major surgical intervention such as cardiovascular surgery:

Considering the clinical data available and good clinical practice guidelines, the Committee deems that EXACYL (tranexamic acid) 0.5 g/5 mL I.V. solution for injection is a first-line treatment in situations requiring inhibition of fibrinolysis:

• in the prevention of haemorrhages, its use should be reserved for major surgeries in which there is a high risk of haemorrhage given the nature of the procedure or the patient’s general condition, such as heart surgery.  The benefit of routine administration has not been established;
• in the event of haemorrhagic shock, management should include the administration of tranexamic acid as soon as possible within the first few hours following the onset of haemorrhagic shock.

In disorders of obstetric origin:

Considering the clinical data available and good clinical practice guidelines, the Committee deems that EXACYL (tranexamic acid) 0.5 g/5 mL I.V. solution for injection has a role in situations requiring inhibition of fibrinolysis:

• in the prevention of haemorrhages, its administration should be reserved for situations in which there is a high risk of postpartum haemorrhage (in particular caesarean section, antepartum bleeding, placental attachment abnormalities), in addition to oxytocin. The benefit of routine administration prior to any delivery has not been demonstrated.
• in the treatment of postpartum haemorrhage resistant to uterotonics. It should be administered as soon as possible, noting that cases of acute kidney injury (including cortical necrosis) have been reported with doses > 2 g.