EFFECT OF PLATELET CONCENTRATE TRANSFUSION ON MICROCIRCULATORY ENDOTHELIAL FUNCTION IN INTENSIVE CARE UNIT (PLATOMIR)

EFFECT OF PLATELET CONCENTRATE TRANSFUSION ON MICROCIRCULATORY ENDOTHELIAL FUNCTION IN INTENSIVE CARE UNIT.

This study aims to investigate the impact of platelet concentrate (PC) transfusions on endothelial function and the systemic inflammatory response in thrombopenic patients admitted to intensive care who require prophylactic platelet transfusions.

Endothelial function will be measured using a laser Doppler device coupled with an acetylcholine iontophoresis system that is applied to the skin.

Study Overview

• Status: Not yet recruiting
• Conditions: Thrombocytopenia; Endothelial Function; Platelet Transfusion; Prophylactic Platelet Transfusion

Detailed Description

This is a single-centre, non-randomised, non-interventional human research study (RIPH3) investigating the impact of platelet transfusion on endothelial function, endothelial biomarkers, systemic inflammation, oxidative stress and peripheral tissue perfusion. Patients will be recruited during their stay in intensive care, after receiving information and providing their consent (non opposition). Platelet transfusion will be prescribed as part of their treatment. Before the transfusion, at the end of the transfusion and one hour afterwards, a clinical examination will be performed, along with an assessment of tissue perfusion and microcirculatory blood flow measurements using a Doppler laser coupled with iontophoresis. Blood samples will be taken before the transfusion and one hour after its completion to assess the systemic inflammatory response. Participation in this research study will take a maximum of four hours. No specific follow-up is planned for patients included in the study.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Hafid AIT-OUFELLA, Pr; Phone Number: +33 01 49 28 23 15; Email: hafid.aitoufella@aphp.fr

Study Locations

• France
  • Paris, France, 75012
    • Medical Intensive Care Unit, Saint-Antoine Hospital, AP-HP, Paris, France
    • Contact: Hafid AIT-OUFELLA, Pr; Phone Number: +33 01 49 28 23 15; Email: hafid.aitoufella@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Any adult admitted to intensive care, regardless of the reason, who has thrombocytopenia and requires prophylactic platelet transfusion

Description

Inclusion Criteria:

• Adult patient ≥ 18 years of age
• Admitted to intensive care
• Requires prophylactic platelet transfusion for thrombocytopenia
• Enrolled in a social security program
• No objection to participating in the study

Exclusion Criteria:

• Recent platelet or red blood cell transfusion (< 24 hours)
• Need for urgent red blood cell transfusion due to active bleeding
• Patient under guardianship or conservatorship
• Significant peripheral edema

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Transfusion; Patients with thrombocytopenia who are admitted to intensive care for any reason and require prophylactic platelet transfusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessing the effects of platelet transfusion on endothelial function in the microcirculation. Endothelial function will be measured using a Doppler laser coupled with an acetylcholine iontophoresis system applied to the skin.	The area under the microcirculatory blood flow curve is measured over 10 minutes using a cutaneous laser Doppler sensor coupled with iontophoresis (Périmed, France). The data is analysed using computer software connected to the Doppler device.	before transfusion, right after transfusion and 1 hour after transfusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endothelial biomarker levels	Endothelial response will be assessed by measuring circulating levels of syndecan-1, hyaluronic acid, ICAM-1, VCAM-1, E-selectin, endothelial protein C receptor (EPCR), and von Willebrand factor.	before transfusion and 1 hour after transfusion
Systemic inflammatory biomarker levels	Systemic inflammation will be assessed by measuring C-reactive protein (CRP), leukocyte count, interleukin (IL)-1β, IL-6, tumor necrosis factor-α (TNF-α), IL-10, CCL2, CCL5, CXCL1, and circulating microparticles.	before transfusion and 1 hour after transfusion
Oxidative stress	Oxidative stress will be assessed by mass spectrometry.	before transfusion and 1 hour after transfusion
Peripheral tissue perfusion	Peripheral tissue perfusion will be assessed by measuring skin recolouration time	before transfusion, right after transfusion and 1 hour after transfusion
Peripheral tissue perfusion	Peripheral tissue perfusion will be assessed using a marbling score	before transfusion, right after transfusion and 1 hour after transfusion
Skin blood flow	Peripheral tissue perfusion will be assessed by measuring skin blood flow in the index finger using a skin Doppler sensor.	before transfusion, right after transfusion and 1 hour after transfusion
Urine output	Peripheral tissue perfusion will be assessed by measuring urine output.	before transfusion, right after transfusion and 1 hour after transfusion

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Hafid AIT-OUFELLA, Pr, APHP

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: June 19, 2026
• First Submitted That Met QC Criteria: June 26, 2026
• First Posted (Actual): July 2, 2026

Study Record Updates

• Last Update Posted (Actual): July 2, 2026
• Last Update Submitted That Met QC Criteria: June 26, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Endothelial Function; ICU; intensive care; oxidative stress; systemic inflammation; Platelet Transfusion; endothelial biomarkers; peripheral tissue perfusion
• Additional Relevant MeSH Terms: Cytopenia; Hematologic Diseases; Blood Platelet Disorders; Hemic and Lymphatic Diseases; Thrombocytopenia
• Other Study ID Numbers: APHP260009; IDRCB 2026-A00031-50 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No