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NCT Number: NCT04580563

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

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.

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Key information

Conditions

Septic Shock Blood Coagulation Disorders Cardiovascular Diseases Coagulopathy Disseminated Intravascular Coagulation Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome Thrombophilia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient with:
  • a septic shock defined by Sepsis-3 criteria (Singer, JAMA 2016)
  • and a coagulopathy assessed by decreased platelets (<150,000/mm3 or >30% decrease within 24 hours) and an INR>1.40 (Vincent, Crit Care Med 2013) without other etiology
  • Randomization within a timeframe of 6 hours after coagulopathy diagnosis
  • Age strictly over 18 years old
  • Subject affiliated to a social health insurance
  • Free and informed consent dated and signed.

Exclusion criteria

  • Contraindication to OctaplasLG®
  • Contraindication to preventive anticoagulation by heparin
  • Any disorder with a requirement for full anticoagulation on the day of randomization
  • PT prolongation or thrombocytopenia that is not due to sepsis
  • History of congenital bleeding disorder predisposing to hemorrhage
  • Medical condition associated with a hypercoagulable state
  • Patient moribund on the day of randomization
  • Do not resuscitate limitation at inclusion in the study
  • Law protection: guardianship or curatorship
  • Pregnancy/breastfeeding

Treatment and study plan

OctaplasLG®

Drug

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.

0.9% NaCl

Drug

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.

Primary outcomes

  1. delays between the diagnosis of coagulopathy and the administration of treatment

    Time frame: Day 2

Secondary outcomes

  1. Mortality

    Time frame: Day 7

  2. SOFA

    Time frame: Day 7

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

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

Acronym: PlasmaFaisa

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Oct 8, 2020
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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