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| ID | Type | Description | Link |
|---|---|---|---|
| IDRCB 2026-A00031-50 | Other Identifier | ANSM |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transfusion | Patients with thrombocytopenia who are admitted to intensive care for any reason and require prophylactic platelet transfusion. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Any adult admitted to intensive care, regardless of the reason, who has thrombocytopenia and requires prophylactic platelet transfusion
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hafid AIT-OUFELLA, Pr | Contact | 01 49 28 23 15 | +33 | hafid.aitoufella@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Hafid AIT-OUFELLA, Pr | APHP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Intensive Care Unit, Saint-Antoine Hospital, AP-HP, Paris, France | Paris | 75012 | France |
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| ID | Term |
|---|---|
| D013921 | Thrombocytopenia |
| ID | Term |
|---|---|
| D001791 | Blood Platelet Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000095542 | Cytopenia |
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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. |
| 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 |