Evaluation of the Prognostic Value of Immature Platelet Fraction

NCT ID: NCT07039227

Last Updated: 2025-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-28

Study Completion Date

2025-12-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Septic Shock

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Sepsis Group

Patient admitted for sepsis in critical care

No interventions assigned to this group

Inflammatory control group

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Rouen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Perrine PL LEPRETRE, Doctor

Role: STUDY_DIRECTOR

University Rouen Hospital

Locations

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University Rouen Hospital

Rouen, , France

Site Status

Countries

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France

Other Identifiers

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N° IDRCB : 2022-A02612-41

Identifier Type: OTHER

Identifier Source: secondary_id

2022/314/OB

Identifier Type: -

Identifier Source: org_study_id

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