Haemocomplettan® P and Fibrogammin® P in acquired hypofibrinogenemia

Project leader: Marisa Warmuth
Project co-operation: Philipp Mad
Duration: October 2009 - January 2010

Publication: HTA Project report No. 39 - https://eprints.aihta.at/870

Background:
Haemocomplettan® P and Fibrogammin® P are being increasingly used in the treatment of acquired hypofibrinogenemia to prevent or stop particularly perioperative bleeding within Austrian hospitals. Furthermore, decisions regarding the substitution of clotting factor concentrates are driven by measuring fibrinogen levels by thrombelastometry (ROTEM®) as a point-of-care device.

Aim and objectives:
The aim of this systematic review is to inform decision makers about the current evidence regarding efficacy and safety of fibrinogen- and FXIII- substitution with clotting factor concentrates in acquired hypofibrinogenemia. 
The objectives are firstly, to evaluate whether the administration of Haemocomplettan® P and/or Fibrogammin® P is superior to the substitution of fresh frozen plasma/Octaplas® and/or cryoprecipitate in acquired hypofibrinogenemia; secondly, to explore the safety of Haemocomplettan® P and Fibrogammin® P; thirdly, to assess whether thrombelastometry (ROTEM®) is superior in providing information about transfusion requirements compared to standard laboratory hemostasis tests, such as the Clauss assay.

PICO question:
Efficacy and safety of Haemocomplettan® P and Fibrogammin® P in acquired hypofibrinogenemia in children and adults compared to FFP and Octaplas® with special consideration of ROTEM® point-of-care testing.

Method:
Systematic Review as outlined in the Internal Manual of the LBI-HTA.