Bicentric Clinical Trial With in Vitro Experiments to Assess the Effect of Fibrinogen (FGTW) on Coagulation in Thrombocytopenia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 5
- 主要终点
- difference in A30 (ExTEM®) between blood samples after in vitro spiking and compared to those blood samples obtained from the same patients after platelet transfusion
研究概览
简要总结
Patients with need of platelet transfusion for any reason will participate in this study. Directly before the start of infusion and one hour after the end of platelet transfusion blood samples will be drawn and treated with different concentrations of Fibrinogen (a blood clotting factor) in-vitro. Blood samples with and without Fibrinogen/platelet transfusion will be compared. The study hypothesis is that treatment with Fibrinogen results in a better stabilisation of blood coagulation.
详细描述
In total 300 patients with the need of platelet transfusion for whatever reason will be included when meeting the inclusion- and exclusion criteria.
For all patients three visits are planned, where blood samples will be taken. The first blood samples will be taken directly before the start of platelet transfusion, the second 1 hour after the end of the platelet transfusion and the third after 24 hours.
Untreated citrate and EDTA blood samples from Visit 1 will be serving as baseline for the coagulation testing. Further citrate blood samples from the first visit will be spiked with different concentrations of fibrinogen in vitro. Untreated citrate and EDTA blood samples will be taken 1 hour and 24 hours after platelet transfusion for comparison. Further citrate blood samples will be spiked with different concentrations of fibrinogen in vitro again 1 hour after platelet transfusion. In addition, randomly chosen samples will be analyzed using confocal microscopy. Routine coagulation analysis include activated partial thromboplastin time (aPTT), prothrombin time(PT), fibrinogen, blood coagulation factor thirteen (FXIII), thromboelastometry (ExTEM & FibTEM) before and after platelet transfusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient with the clinical need for platelet transfusion
- •age: 18 - 85 years
排除标准
- •pregnant or nursing women
- •patients who disagree to participate in the study
- •for emergency patients: patients with known refusal of a participation in this clinical trial
- •active participation in a clinical trial
- •any condition, including the presence of laboratory abnormalities, which would place confound in the ability to interpret data from the study
- •any serious medical condition, laboratory abnormalities, or psychiatric illness, that would prevent the subject from signing the informed consent form
研究组 & 干预措施
Platelet concentrate transfusion and Human Fibrinogen
Blood samples will be collected directly before the start of transfusion and 1 hour after the end of transfusion. These samples will be spiked with Human Fibrinogen and clotting tests will be performed. After 24 h after end of transfusion a clotting test will be performed again.
干预措施: Administration of platelet concentrate and taking blood samples (Drug)
结局指标
主要结局
difference in A30 (ExTEM®) between blood samples after in vitro spiking and compared to those blood samples obtained from the same patients after platelet transfusion
时间窗: 1 hour after platelet transfusion
次要结局
- Assessment of the difference in the response profile of Blood cell count (EDTA blood sample)(before and 1 hour after platelet transfusion)
- Standard coagulation tests as aPTT, PT, fibrinogen and FXIII(before and 1 hour after platelet transfusion)
- Further bleeding management system(ROTEM®)parameters(before and one hour after platelet transfusion)
研究者
Dietmar Fries, M.D.
Ao. Univ.-Prof. Dr.
Medical University Innsbruck