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NCT Number: NCT07039227

Evaluation of the Prognostic Value of Immature Platelet Fraction

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Rouen Hospital

Rouen, 76031, France

About this study

In the pathophysiology of host defense against infection, coagulation plays a major role. In the most severe forms of sepsis, there is an activation of coagulation, particularly platelets, which can cause an alteration of microcirculation and contribute to organ failure. This mechanism is called thromboinflammation. The appearance of thrombocytopenia in sepsis is a risk factor for severity and intrahospital mortality. Immature (or reticulated) platelets are young platelets that have just been released by the bone marrow. They are more prothrombotic and hyperactive than more mature platelets. They are a good marker of thrombopoiesis and platelet renewal, and can be easily obtained routinely on a complete blood count. Several studies show that the immature platelet count and/or fraction (IPF) could be a useful tool for predicting the development of sepsis and its severity. It appears interesting to study these IPFs in patients with sepsis to identify them and implement more aggressive therapies to prevent adverse outcomes in these patients. To distinguish between sepsis and inflammation and validate this marker, it will be compared to an inflammatory group using patients who underwent cardiopulmonary bypass as part of cardiac surgery.

The main objective of this study is to investigate the potential impact of the immature platelet fraction on the prognosis at day 28 of patients admitted to critical care for sepsis or septic shock.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Exclusion Criteria:
  • 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

Treatment and study plan

Primary outcomes

  1. 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.

    Time frame: Days 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

  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.

    Time frame: Days 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)

Secondary outcomes

  1. To assess the impact of the immature platelet fraction on the occurrence of thrombocytopenia

    Time frame: days 28

    Occurrence of thrombocytopenia defined by a fall > or = to 30% of its baseline value or a platelet count < less than 150,000 G/L

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

    Time frame: Days 28

    Demonstration of disseminated intravascular coagulation (DIC)

  3. Evaluation of the impact of the immature platelet fraction on the occurrence of thromboembolic events

    Time frame: Days 28

    Evidence of the onset of thromboembolic venous disease

  4. Assessment of the occurrence of multiple organ failure syndrome

    Time frame: Days 28

    Evidence of a multi-organ failure syndrome defined by the occurrence of at least 2 organ failures

  5. Assessment of the occurrence of recourse to mechanical ventilation

    Time frame: Days 28

    Highlighting the use of mechanical ventilation

  6. Assessment of mortality in intensive care, in hospital and on D28

    Time frame: At enrollment visit, day 1, days 3, days 7 and Days 28

    Determination of Mortality in intensive care, in hospital and on D28

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study title

Evaluation of the Prognostic Value of Immature Platelet Fraction in Septic Patients Admitted to Critical Care

Acronym: IPSIS

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 26, 2025
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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