RESTORVOL, (hydroxyethyl starch), colloidal volume replacement solutions

ANAESTHESIA-INTENSIVE CARE - Review
Opinions on drugs - Posted on Feb 24 2015

Reason for request

Reassessment of Actual Benefit

Limited role in 2nd-line treatment of hypovolaemia due to acute blood loss because of the observed excess death rate and cases of sepsis in intensive care.

 

  • Volume replacement solutions based on hydroxyethyl starch (HES) now only have Marketing Authorization in the treatment of hypovolemia due to acute blood loss when the use of crystalloids alone is not considered sufficient.
  • Their use is associated with an excess death rate at 90 days within the framework of sepsis in patients requiring intensive care. To date, it is not possible to extrapolate this risk to cases of acute blood loss.
  • Crystalloids are very often sufficient for the rapid re-establishment of the blood volume. Solutions based on HES have a moderate benefit, in the postoperative context only, in the management of acute haemorrhage.

Clinical Benefit

Moderate

RESTORVOL 6 % has a moderate actual benefit after an inadequate response to crystalloids in the new Marketing Authorisation indication, solely in patients who have undergone surgery or for management of acute blood loss.