Study Assessing Efficacy of Plasmatherapy in Septic Shock-induced Coagulopathy: Feasibility Study
Status:
Active, not recruiting
Trial end date:
2022-06-01
Target enrollment:
Participant gender:
Summary
No randomized controlled trial (RCT) has investigated the effect of prophylactic fresh frozen
plasma (FFP) transfusion in septic or critically ill patients with coagulation abnormalities.
The last Surviving Sepsis Campaign therefore suggests with a very low quality of evidence
"against the use of fresh frozen plasma during septic shock to correct clotting abnormalities
in the absence of bleeding or planned invasive procedures". However, expert opinion
highlights that FFP should be transfused "when there is a documented deficiency of
coagulation factors (increased prothrombin time, international normalized ratio - INR, or
partial thromboplastin time) and the presence of active bleeding or before surgical or
invasive procedures". Disseminated intravascular coagulation (DIC) is responsible for such a
severe deficiency of coagulation factors. Supplementing the intense deficit of coagulation
factors with plasma containing non-activated coagulation factors is therefore a rational
therapy in DIC patients.
OctaplasLG® is a donor plasma product, with unique features compared to standard fresh frozen
plasma: standardized concentrations of natural pro-/anti-coagulation factors; a standardized
volume; pathogen free. OctaplasLG® should reduce the "inflammatory hit" on the endothelium,
including the glycocalyx, by having standardized levels of coagulation proteins, which can
give more sustainable support to the endothelial regeneration as compared to standard fresh
frozen plasma.