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临床试验/NCT00994045
NCT00994045已完成4 期

Coagulopathy During Surgery for the Repair of Extent 4 Thoraco-Abdominal Aortic Aneurysms - Feasibility Study of the Use of Fibrinogen Concentrate by Infusion in Place of Fresh Frozen Plasma.

University of Edinburgh1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2010年6月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
20
试验地点
1
主要终点
Pattern of coagulation disturbance in the conventional treatment (FFP) and fibrinogen concentrate groups.

研究概览

简要总结

Thoracoabdominal aneurysm (TAAA) repair is a major elective vascular operation associated with a large blood loss and potentially life-threatening clotting abnormalities. Theses clotting abnormalities are principally treated using fresh frozen plasma (FFP) (derived from human blood donations), the administration of which carries a number of risks including virus transmission (human immunodeficiency virus (HIV), hepatitis B, hepatitis C) and infection with variant Creutzfeld-Jacob disease (vCJD). FFP is no longer administered to children or high-usage adults in the UK because of the infection risk, and recently it was decided by a UK advisory body that the use of UK-derived FFP should cease.

Fibrinogen concentrate is an alternative treatment option to FFP which is thought have less infection risk (purified, heat treated) and has been in licensed use for many years in other European countries. The investigators have been using fibrinogen concentrate recently in their department as an alternative to FFP with encouraging results.

20 patients undergoing elective TAAA repair at The Royal Infirmary of Edinburgh will be randomly allocated to receive standard treatment (FFP) or fibrinogen concentrate as treatment for clotting abnormalities during their surgery. The investigators will take a number of additional blood samples which will provide valuable information about the pattern of clotting abnormalities during this type of operation. The investigators will also record blood loss and the number of allogeneic (derived from human donors) blood components transfused to the patient (red cells, FFP and platelets). Our primary objective is to assess the pattern of coagulation abnormalities in both groups. We will also examine whether the use of fibrinogen concentrate during TAAA repair avoids the need to administer FFP.

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
Single (Participant)

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

  • •Undergoing elective thoracoabdominal aneurysm repair.
  • •Over 18 years of age.
  • •Able to give written informed consent.

排除标准

  • •Previous aortic surgery (re-do surgery).
  • •Emergency surgery.
  • •Pregnancy.
  • •Females of child-bearing age (less than 45 years) not using medically approved method of contraception.
  • •Congenital or acquired coagulopathy.
  • •Known allergy to study drug.

研究组 & 干预措施

Fresh Frozen Plasma

Active Comparator

干预措施: Fresh Frozen Plasma (Biological)

Fibrinogen concentrate

Experimental

干预措施: Fibrinogen concentrate (Biological)

结局指标

主要结局

Pattern of coagulation disturbance in the conventional treatment (FFP) and fibrinogen concentrate groups.

时间窗: Inra-operatively, and up to 24 hours post-operatively.

次要结局

  • Proportion of patients in the fibrinogen group in whom FFP transfusion is required during surgery.(Operative period.)
  • Units of FFP transfused - during surgery and up to 24 hours after surgery.(Peri-operative period.)
  • Units of platelets and allogeneic red cells transfused - during surgery and up to 24 hours after surgery.(Peri-operative period.)
  • Blood loss.(Operative period.)

研究者

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

Alastair Nimmo

Dr

University of Edinburgh

研究点 (1)

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