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临床试验/NCT02299947
NCT02299947终止4 期

Comparison of a Single Dose Fibrinogen With Placebo and the Number of Blood Transfusions After Ascending Aorta Surgery (FIBTEG Study)

St. Antonius Hospital1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2014年8月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
入组人数
27
试验地点
1
主要终点
Number of transfused blood products

研究概览

简要总结

The purpose of this study is to answer the following question: Leads a primary coagulation corrected with a single dose of fibrinogen concentrate after ascending aorta-arc reconstruction to a decrease in the number of allogenic blood transfusions, compared to placebo?

详细描述

Cardiothoracic surgery (CTC) is associated with blood loss and an increased risk for impaired coagulation by the use of a CBP. Coagulation is a process of primary hemostasis by adhesion of trombocytes and aggregation, followed by secondary coagulation and fibrin formation. During CTC fibrinogen is the first coagulation factor which reaches critical concentration necessary for clotting. Point of Care clotting assay with thromboelastography (TEG) provides qualitative information on coagulation factors and clot strength. Specific coagulation factor correction of impaired clotting improves clot strength and may reduces the number of perioperative allogeneic blood transfusions, resulting in possible reduction of postoperative blood loss and reduction of the risk of re-operation in the short and long term. The hypothesis of this study is that a single dose fibrinogen concentrate immediately after CTC leads to a decrease in the number of allogenic blood transfusions in patients with clinically impaired clotting, verified by TEG.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Elective surgery for thoracic aneurysm

排除标准

  • Prior trombosis or myocardial infarction, congenital coagulation disorder, use of anti-coagulants prior to surgery, prior thoracic surgery, pregnancy, pre-operative fibrinogen concentration <1g/L

研究组 & 干预措施

Haemocomplettan P

Experimental

Study patients that receive Haemocomplettan P

干预措施: Haemocomplettan P (Drug)

NaCl 0.9%

Placebo Comparator

Study patients that receive NaCl 0.9%

干预措施: Placebo (Drug)

结局指标

主要结局

Number of transfused blood products

时间窗: 24 hours after surgery

次要结局

  • Mortality(30 day mortality)
  • Blood loss(24 hours after surgery)
  • Re-operation(30 day after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

dr. P. Noordzij

MD PhD

St. Antonius Hospital

研究点 (1)

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