Clinical trials are looking at the potential of fibrinogen, or Factor I, to cut the need for blood transfusions during surgery
When patients are undergoing surgery, there is always the risk of bleeding, not just from the surgical incisions but also from non-surgical complications. This results from a critical reduction in the level of coagulation factors.
Fibrinogen, or Factor I, is the first of these factors to become depleted, with the result being a reduction in the blood’s ability to clot. Very low levels of fibrinogen can greatly increase the likelihood of bleeding during surgical procedures, but there is only limited clinical evidence of its effects on the need for transfusion.
Already available to treat acquired bleeding indications in several countries under the brand name Haemocomplettan P, CSL Behring is now running clinical trials looking at its potential to cut the need for blood transfusions during surgery.1
In a pilot study in patients undergoing aortic valve operations or aortic replacement, where bleeding is normally controlled using fresh-frozen plasma and platelet concentrates, 62 patients were given standard add-on treatment, and a further five were given fibrinogen concentrate in advance of this. A mean of 5.7g of fibrinogen concentrate was sufficient to reduce blood loss to below the transfusion trigger level in all five of these patients. They also experienced lower levels of post-operative bleeding.
As a result, a randomised, prospective, placebo-controlled, double blind trial looking at its potential as first line therapy during major aortic replacement surgery was carried out.2
A total of 61 patients were given either fibrinogen concentrate or placebo, and in the first 24 hours after surgery those in the group given the concentrate received fewer allogeneic blood components than the placebo group – 45% of the treated group needed no transfusion whatsoever, whereas all of those given placebo did.
1. N. Rahe-Meyer et al. Br. J. Anaesth. 2009, 102, 785
2. N. Rahe-Meyer et al. Anesthesiology 2012, 118, 40