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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04580563
Other study ID # 7572
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 22, 2020
Est. completion date January 3, 2023

Study information

Verified date January 2023
Source University Hospital, Strasbourg, France
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date January 3, 2023
Est. primary completion date December 9, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
France Hôpitaux Universitaires de Strasbourg Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary delays between the diagnosis of coagulopathy and the administration of treatment Day 2
Secondary Mortality Day 7
Secondary SOFA Day 7
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