EFFECT OF PLATELET CONCENTRATE TRANSFUSION ON MICROCIRCULATORY ENDOTHELIAL FUNCTION IN INTENSIVE CARE UNIT (PLATOMIR)
26. juni 2026 oppdatert av: Assistance Publique - Hôpitaux de Paris
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.
Studieoversikt
Status
Har ikke rekruttert ennå
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Antatt)
60
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Hafid AIT-OUFELLA, Pr
- Telefonnummer: +33 01 49 28 23 15
- E-post: hafid.aitoufella@aphp.fr
Studiesteder
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-
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Paris, Frankrike, 75012
- Medical Intensive Care Unit, Saint-Antoine Hospital, AP-HP, Paris, France
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Ta kontakt med:
- Hafid AIT-OUFELLA, Pr
- Telefonnummer: +33 01 49 28 23 15
- E-post: hafid.aitoufella@aphp.fr
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Any adult admitted to intensive care, regardless of the reason, who has thrombocytopenia and requires prophylactic platelet transfusion
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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Transfusion
Patients with thrombocytopenia who are admitted to intensive care for any reason and require prophylactic platelet transfusion.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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.
Tidsramme: before transfusion, right after transfusion and 1 hour after transfusion
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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.
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before transfusion, right after transfusion and 1 hour after transfusion
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Endothelial biomarker levels
Tidsramme: before transfusion and 1 hour after transfusion
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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.
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before transfusion and 1 hour after transfusion
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Systemic inflammatory biomarker levels
Tidsramme: before transfusion and 1 hour after transfusion
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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.
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before transfusion and 1 hour after transfusion
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Oxidative stress
Tidsramme: before transfusion and 1 hour after transfusion
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Oxidative stress will be assessed by mass spectrometry.
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before transfusion and 1 hour after transfusion
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Peripheral tissue perfusion
Tidsramme: before transfusion, right after transfusion and 1 hour after transfusion
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Peripheral tissue perfusion will be assessed by measuring skin recolouration time
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before transfusion, right after transfusion and 1 hour after transfusion
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Peripheral tissue perfusion
Tidsramme: before transfusion, right after transfusion and 1 hour after transfusion
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Peripheral tissue perfusion will be assessed using a marbling score
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before transfusion, right after transfusion and 1 hour after transfusion
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Skin blood flow
Tidsramme: before transfusion, right after transfusion and 1 hour after transfusion
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Peripheral tissue perfusion will be assessed by measuring skin blood flow in the index finger using a skin Doppler sensor.
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before transfusion, right after transfusion and 1 hour after transfusion
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Urine output
Tidsramme: before transfusion, right after transfusion and 1 hour after transfusion
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Peripheral tissue perfusion will be assessed by measuring urine output.
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before transfusion, right after transfusion and 1 hour after transfusion
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Hafid AIT-OUFELLA, Pr, APHP
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. juli 2026
Primær fullføring (Antatt)
1. juli 2027
Studiet fullført (Antatt)
1. juli 2027
Datoer for studieregistrering
Først innsendt
19. juni 2026
Først innsendt som oppfylte QC-kriteriene
26. juni 2026
Først lagt ut (Faktiske)
2. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
2. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
26. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- APHP260009
- IDRCB 2026-A00031-50 (Annen identifikator: ANSM)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
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Nei
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