NCT04580563

Study Assessing Efficacy of Plasmatherapy in Septic Shock-induced Coagulopathy: Feasibility Study

Prospective Randomized Versus Placebo Study Assessing Efficacy of Plasmatherapy in Septic Shock-induced Coagulopathy: Feasibility Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University Hospital, Strasbourg, France · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The present RCT is an open-label faisability study. OctaplasLG® or a placebo (0.9% NaCl) will be allocated to patients with a septic shock-induced coagulopathy defined by decreased platelets (\<150,000/mm3 or \>30% decrease within 24 hours) and an INR\>1.40, and started within the 6 hours following coagulopathy diagnosis.

Conditions

• Septic Shock
• Coagulopathy
• Disseminated Intravascular Coagulation

Interventions

Type	Name	Description
DRUG	OctaplasLG®	Patient receive 12 ml/kg of OctaplasLG® at day 1, within the 2 hours after randomization (i.e. within the 8 hours after coagulopathy diagnosis). A new identical dose will be infused at day 2 according to coagulation parameters.
DRUG	0.9% NaCl	Patient receive 12 ml/kg of placebo (0.9% NaCl) at day 1, within the 2 hours after randomization (i.e. within the 8 hours after coagulopathy diagnosis). A new identical dose will be infused at day 2 according to coagulation parameters.

Timeline

• Start date: 2020-10-22
• Primary completion: 2022-12-09
• Completion: 2023-01-03
• First posted: 2020-10-08
• Last updated: 2026-03-16

Locations

1 site across 1 country: France