EFFECT OF PLATELET CONCENTRATE TRANSFUSION ON MICROCIRCULATORY ENDOTHELIAL FUNCTION IN INTENSIVE CARE UNIT.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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.
时间窗: 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.
次要结局
- Endothelial biomarker levels(before transfusion and 1 hour after transfusion)
- Systemic inflammatory biomarker levels(before transfusion and 1 hour after transfusion)
- Oxidative stress(before transfusion and 1 hour after transfusion)
- Peripheral tissue perfusion(before transfusion, right after transfusion and 1 hour after transfusion)
- Skin blood flow(before transfusion, right after transfusion and 1 hour after transfusion)
- Urine output(before transfusion, right after transfusion and 1 hour after transfusion)