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临床试验/EUCTR2009-017736-41-DK
EUCTR2009-017736-41-DK进行中(未招募)1 期

Fibrinogen-koncentrat som initial behandling ved postpartum blødning - [FIB·PPH]-studiet

Anæstesiologisk Afd. Herlev Hospital0 个研究点目标入组 245 人开始时间: 2010年2月9日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
245

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
Female

入选标准

  • PPH defineret som blødning fra uterus og/eller fødselskanalen opstået indenfor de første 24
  • timer efter fødsel. Alder = 18 år. Samtykke fra patient eller forsøgsværge.
  • Vaginal forløsning: Ved indikation for ét af følgende postnatale indgreb udført på operationsgangen med
  • anæstesiologisk assistance:
  • i.Ved estimeret blodtab = 500 ml og indikation for manuel placentafjernelse.
  • ii.Ved manuel eksploration af uterus på grund af blødning efter placentas fødsel.
  • Forløsning ved sectio: Peroperativt blodtab =1000 ml.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Patienter med kendt medfødt koagulationsdefekt.
  • Patienter, der præpartum er i behandling med antitrombotiske midler: AK- behandling (Warfarin), trombocythæmmende midler (Clopidogrel og Acetylsalicylsyre), lavmolekulært heparin (LMWH). Omfattende terapeutiske såvel som profylaktiske doser.
  • Patienter med en prægraviditetsvægt
  • Patienter der på forhånd modsætter sig blodtransfusion.

研究者

发起方
Anæstesiologisk Afd. Herlev Hospital

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