Evaluation of the Prognostic Value of Immature Platelet Fraction

NCT07039227 | Completed

• 2 other identifiers: 2022/314/OBN° IDRCB : 2022-A02612-41
• Study Type: observational
• Target: 196
• Locations: 1 country
• Sites: 1

Brief Summary

Sepsis is a public health issue responsible for six million deaths worldwide each year. It is one of the leading causes of admission and morbidity and mortality in critical care. Its most severe form, septic shock, is responsible for a picture of multiple organ failure syndrome with a high mortality rate estimated at 38%. It appears important to identify routinely available and low-cost biomarkers to identify patients at risk of adverse outcomes.

Conditions

Septic Shock

Keywords

coagulation; highlighting of biomarkers

Outcome Measures

Primary Outcomes (2)

• Evaluation of the impact of the immature platelet fraction of patients admitted to intensive care for sepsis or septic shock on their prognosis at day 28.

  Measurement of the fraction of immature platelets at admission in patients with sepsis or septic shock defined by the composite criterion calculated on the occurrence of death at 28 days of follow-up

  Days 28

• Evaluation of the impact of the immature platelet fraction of patients admitted to intensive care for sepsis or septic shock on their prognosis at day 28.

  Measurement of the fraction of immature platelets at admission in patients with sepsis or septic shock defined by the composite criterion calculated on the occurrence of organ failure: implementation of extrarenal purification and/or renal failure KDIGO 3 and/or moderate to severe acute respiratory distress syndrome and/or intense vasoplegic septic shock with noradrenaline \> 0.25 µg/kg/min or vasopressin \> 0.02 IU/h and/or myocardial dysfunction with venous oxygen saturation \< 60 or a cardiac index \< 2.2 l/min/m2 and/or occurrence of disseminated intravascular coagulation (DIC)

  Days 28

Secondary Outcomes (6)

• To assess the impact of the immature platelet fraction on the occurrence of thrombocytopenia

  days 28

• Assess the impact of the immature platelet fraction on the progression to disseminated vascular coagulopathy

  Days 28

• Evaluation of the impact of the immature platelet fraction on the occurrence of thromboembolic events

  Days 28

• Assessment of the occurrence of multiple organ failure syndrome

  Days 28

• Assessment of the occurrence of recourse to mechanical ventilation

  Days 28

Study Arms (2)

Sepsis Group

Patient admitted for sepsis in critical care

Inflammatory control group

Patient admitted for an anesthesia consultation for cardiac surgery under extracorporeal circulation

Eligibility Criteria

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

Study Population

Patients admitted to critical care for sepsis or septic shock

You may qualify if:

• Any adult patient admitted to critical care for sepsis defined by a SOFA score \> or = 2 or an increase of at least 2 points if there was organ dysfunction pre-existing to the infection.
• For the inflammatory control group, we will include adult patients who have required extracorporeal circulation for more than 1 hour for cardiac surgery.
• Patients who have read and understood the information letter and do not object to participating in the study
• Patients affiliated with a social security scheme

You may not qualify if:

• Patient refusal
• Pregnant, parturient, or breastfeeding woman
• Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection/guardianship or curatorship
• Person who does not understand or speak French
• Moribund
• Febrile aplasia
• Hematological diseases
• Decompensated cirrhosis
• Ongoing chemotherapy

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

University Rouen Hospital

Rouen, 76031, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

At each patient follow-up time (At enrollment visit, 1-day visit, 3-day visit, 7-day visit), 4 tubes of 4 mL of blood will be collected (a total of 16 mL): 2 EDTA tubes for research, 1 citrated tube and one dry tube.

MeSH Terms

Conditions

Shock, Septic; Thrombosis

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Perrine PL LEPRETRE, Doctor

  University Rouen Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: June 26, 2025
• Study Start: April 28, 2023
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 13, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)