Clinical Trials Logo
  1. Home
  2. Septic Shock
  3. NCT04580563

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

Septic Shock Clinical Trial

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

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04580563
Study type Interventional
Source University Hospital, Strasbourg, France
Contact
Status Completed
Phase N/A
Start date October 22, 2020
Completion date January 3, 2023
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT03649633 - Vitamin C, Steroids, and Thiamine, and Cerebral Autoregulation and Functional Outcome in Septic Shock Phase 1/Phase 2
Terminated NCT04117568 - The Role of Emergency Neutrophils and Glycans in Postoperative and Septic Patients
Completed NCT04227652 - Control of Fever in Septic Patients N/A
Completed NCT05629780 - Temporal Changes of Lactate in CLASSIC Patients N/A
Recruiting NCT04796636 - High-dose Intravenous Vitamin C in Patients With Septic Shock Phase 1
Terminated NCT03335124 - The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock Phase 4
Recruiting NCT04005001 - Machine Learning Sepsis Alert Notification Using Clinical Data Phase 2
Recruiting NCT05217836 - Iron Metabolism Disorders in Patients With Sepsis or Septic Shock.
Recruiting NCT05066256 - LV Diastolic Function vs IVC Diameter Variation as Predictor of Fluid Responsiveness in Shock N/A
Not yet recruiting NCT05443854 - Impact of Aminoglycosides-based Antibiotics Combination and Protective Isolation on Outcomes in Critically-ill Neutropenic Patients With Sepsis: (Combination-Lock01) Phase 3
Not yet recruiting NCT04516395 - Optimizing Antibiotic Dosing Regimens for the Treatment of Infection Caused by Carbapenem Resistant Enterobacteriaceae N/A
Recruiting NCT02899143 - Short-course Antimicrobial Therapy in Sepsis Phase 2
Recruiting NCT02580240 - Administration of Hydrocortisone for the Treatment of Septic Shock N/A
Recruiting NCT02565251 - Volemic Resuscitation in Sepsis and Septic Shock N/A
Recruiting NCT02676427 - Fluid Responsiveness in Septic Shock Evaluated by Caval Ultrasound Doppler Examination
Completed NCT02638545 - Hemodynamic Effects of Dexmedetomidine in Septic Shock Phase 3
Not yet recruiting NCT02547467 - TOADS Study: TO Assess Death From Septic Shock. N/A
Terminated NCT02335723 - ASSET - a Double-Blind, Randomized Placebo-Controlled Clinical Investigation With Alteco® LPS Adsorber N/A
Completed NCT02204852 - Co-administration of Iloprost and Eptifibatide in Septic Shock Patients Phase 2
Completed NCT02306928 - PK Analysis of Piperacillin in Septic Shock Patients N/A