NCT04107402

Brief Summary

Knowing the dramatic increase in thrombin generation during sepsis, our research hypothesis is that AMPK-induced ACC phosphorylation in platelets is increased and that this might modulate platelets metabolism and more particularly platelets inflammatory mediators content, coming from AA and lipids.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2019

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

April 11, 2019

Completed
6 months until next milestone

First Posted

Study publicly available on registry

September 27, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2021

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2024

Completed
Last Updated

April 15, 2025

Status Verified

April 1, 2025

Enrollment Period

2 years

First QC Date

April 11, 2019

Last Update Submit

April 10, 2025

Conditions

Septic ShockPlatelet Signal Processing DefectInflammatory ResponseDisseminated Intravascular CoagulationCovid19Neutrophil Extracellular Trap Formation

Keywords

Septic shockPlateletsAcetyl CoA Carboxylase

Outcome Measures

Primary Outcomes (1)

  • Platelets Acetyl-CoA Carboxylase phosphorylation rate

    ACC phosphorylation on Ser79 (phosphoACC) in platelets of patients will be assessed using western blotting. Results will be expressed in arbitrary units (A.U). A signal above 0.5 A.U. has already been shown to be above 2 standard deviation in a healthy population.

    At the time of inclusion

Secondary Outcomes (14)

  • Sepsis severity

    At the time of inclusion

  • Sepsis severity

    At the time of inclusion

  • Mortality rate

    30 days and 1-year follow-up

  • Platelet function assessment

    At the time of inclusion

  • Platelet function assessment

    At the time of inclusion

  • +9 more secondary outcomes

Study Arms (3)

Septic shock

EXPERIMENTAL

Septic shock Patients admitted to the ICU

Other: Assessment of coagulopathy, Platelets activation and Platelets-Neutrophils interplay

Control group

OTHER

Patients recruited at the central lab of the hospital, with matched age, gender and comorbidities

Other: Assessment of coagulopathy, Platelets activation and Platelets-Neutrophils interplay

Covid-19

EXPERIMENTAL

Covid-19 patients admitted to the ICU for Acute Respiratory Distress Syndrom with PaO2/FiO2 \< 200

Other: Assessment of coagulopathy, Platelets activation and Platelets-Neutrophils interplay

Interventions

Assessment of coagulopathy, Platelets activation and Platelets-Neutrophils interplayOTHER

Blood sample Urine Sample Pulmonary, hepatic and cardiac tissue from biopsy and autopsy

Also known as: Inflammatory biomarkers, Coagulation assessment, Platelets activation state assessment, Neutrophils Extra-cellular trap assessment, Quantification and analysis of micro-thrombi, Platelets Acetyl-CoA Carboxylase phosphorylation analysis
Control groupCovid-19Septic shock

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed consent of patients, their relatives or independent physician

You may not qualify if:

  • Patients on therapeutic anticoagulation therapy (oral or parenteral) including heparins, fondaparinux, vitamin K antagonist, novel oral anticoagulants, for any reasons DESPITE therapeutic anticoagulation as a treatment for Covid-19 patients.
  • Recent (less than 1 month) chemotherapy
  • Active inflammatory disease
  • Haemophilia and other coagulopathy
  • Previous history of thrombocytopenia (\<100 000 platelets/mm3)
  • Cirrhosis (Child Plug \> A)
  • Recent (less than 48 hours) major surgery
  • \- bacterial co-infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques Universitaires St Luc

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Shock, SepticPlatelet Signal Processing DefectDisseminated Intravascular CoagulationCOVID-19

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShockBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersThrombophiliaPneumonia, ViralPneumoniaRespiratory Tract InfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Christophe Beauloye, MD

    Cliniques Universitaires St Luc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2019

First Posted

September 27, 2019

Study Start

March 15, 2019

Primary Completion

March 15, 2021

Study Completion

March 15, 2024

Last Updated

April 15, 2025

Record last verified: 2025-04

Locations

BE(1)