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NCT Number: NCT07682246

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical Intensive Care Unit, Saint-Antoine Hospital, AP-HP, Paris, France

Paris, 75012, France

Location contact

Hafid AIT-OUFELLA, Pr

CONTACT

[email protected]

01 49 28 23 15 ext. +33

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. 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.

    Time frame: before transfusion, right after transfusion and 1 hour after transfusion

    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.

Secondary outcomes

  1. Endothelial biomarker levels

    Time frame: before transfusion and 1 hour after transfusion

    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.

  2. Systemic inflammatory biomarker levels

    Time frame: before transfusion and 1 hour after transfusion

    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.

  3. Oxidative stress

    Time frame: before transfusion and 1 hour after transfusion

    Oxidative stress will be assessed by mass spectrometry.

  4. Peripheral tissue perfusion

    Time frame: before transfusion, right after transfusion and 1 hour after transfusion

    Peripheral tissue perfusion will be assessed by measuring skin recolouration time

  5. Peripheral tissue perfusion

    Time frame: before transfusion, right after transfusion and 1 hour after transfusion

    Peripheral tissue perfusion will be assessed using a marbling score

  6. Skin blood flow

    Time frame: before transfusion, right after transfusion and 1 hour after transfusion

    Peripheral tissue perfusion will be assessed by measuring skin blood flow in the index finger using a skin Doppler sensor.

  7. Urine output

    Time frame: before transfusion, right after transfusion and 1 hour after transfusion

    Peripheral tissue perfusion will be assessed by measuring urine output.

Study contacts

Contact information is provided by the study sponsor or research team.

Hafid AIT-OUFELLA, Pr

CONTACT

[email protected]

01 49 28 23 15 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: PLATOMIR

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 2, 2026
Registry last updated
Jul 2, 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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