Medical Intensive Care Unit, Saint-Antoine Hospital, AP-HP, Paris, France
Paris, 75012, France
NCT Number: NCT07682246
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Paris, 75012, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Time frame: before transfusion and 1 hour after transfusion
Oxidative stress will be assessed by mass spectrometry.
Time frame: before transfusion, right after transfusion and 1 hour after transfusion
Peripheral tissue perfusion will be assessed by measuring skin recolouration time
Time frame: before transfusion, right after transfusion and 1 hour after transfusion
Peripheral tissue perfusion will be assessed using a marbling score
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.
Time frame: before transfusion, right after transfusion and 1 hour after transfusion
Peripheral tissue perfusion will be assessed by measuring urine output.
Contact information is provided by the study sponsor or research team.
Assistance Publique - Hôpitaux de Paris
Other
EFFECT OF PLATELET CONCENTRATE TRANSFUSION ON MICROCIRCULATORY ENDOTHELIAL FUNCTION IN INTENSIVE CARE UNIT.
Acronym: PLATOMIR
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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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