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

NCT04580563 | Completed

• 2 other identifiers: 75722019-004769-41
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Septic Shock; Coagulopathy; Disseminated Intravascular Coagulation

Keywords

septic shock; coagulopathy; disseminated intravascular coagulation; plasmatherapy

Outcome Measures

Primary Outcomes (1)

• delays between the diagnosis of coagulopathy and the administration of treatment

  Day 2

Secondary Outcomes (2)

• Mortality

  Day 7

• SOFA

  Day 7

Study Arms (2)

Experimental group

EXPERIMENTAL

The experimental group will 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. 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.

Drug: OctaplasLG®

Control group

PLACEBO COMPARATOR

The control group will 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.

Drug: 0.9% NaCl

Interventions

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.

Experimental group

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Law protection: guardianship or curatorship
• Pregnancy/breastfeeding

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67000, France

Location

MeSH Terms

Conditions

Shock, Septic; Hemostatic Disorders; Disseminated Intravascular Coagulation

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Julie HELMS, MD

  Hôpitaux Universitaires de Strasbourg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2020
• First Posted: October 8, 2020
• Study Start: October 22, 2020
• Primary Completion: December 9, 2022
• Study Completion: January 3, 2023
• Last Updated: March 16, 2026

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)