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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07682246
Acronym
PLATOMIR
Enrollment
60
Registered
2026-07-02
Start date
2026-07-01
Completion date
2027-07-01
Last updated
2026-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endothelial Function, Platelet Transfusion, Prophylactic Platelet Transfusion, Thrombocytopenia

Keywords

ICU, intensive care, Platelet Transfusion, Endothelial Function, endothelial biomarkers, systemic inflammation, oxidative stress, peripheral tissue perfusion

Brief summary

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.

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.

Interventions

None listed

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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.before transfusion, right after transfusion and 1 hour after transfusionThe 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

MeasureTime frameDescription
Oxidative stressbefore transfusion and 1 hour after transfusionOxidative stress will be assessed by mass spectrometry.
Peripheral tissue perfusionbefore transfusion, right after transfusion and 1 hour after transfusionPeripheral tissue perfusion will be assessed by measuring skin recolouration time
Systemic inflammatory biomarker levelsbefore transfusion and 1 hour after transfusionSystemic 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.
Urine outputbefore transfusion, right after transfusion and 1 hour after transfusionPeripheral tissue perfusion will be assessed by measuring urine output.
Endothelial biomarker levelsbefore transfusion and 1 hour after transfusionEndothelial 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.
Skin blood flowbefore transfusion, right after transfusion and 1 hour after transfusionPeripheral tissue perfusion will be assessed by measuring skin blood flow in the index finger using a skin Doppler sensor.

Countries

France

Contacts

CONTACTHafid AIT-OUFELLA, Pr
hafid.aitoufella@aphp.fr01 49 28 23 15
PRINCIPAL_INVESTIGATORHafid AIT-OUFELLA, Pr

APHP

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 3, 2026