ISRCTN46295339已完成未知
Fibrinogen concentrate versus placebo for treatment of postpartum haemorrhage: a multicentre, prospective, double blind randomised controlled trial
Cardiff University (UK)0 个研究点目标入组 1,050 人开始时间: 2013年7月1日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 1,050
研究概览
简要总结
2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25906770 2017 results in: http://www.ncbi.nlm.nih.gov/pubmed/28969328 2017 results in: http://www.ncbi.nlm.nih.gov/pubmed/28969312
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Age 18 years or over
- •2. Women should have any one of the following within the first 12 hours after delivery:
- •2.1. Haemorrhage of about 1500 ml and ongoing bleeding without another complication
- •2.2. Haemorrhage of about 1000 mL and ongoing bleeding with any of:
- •2.2.1. caesarean section
- •2.2.2. uterine atony
- •2.2.3. placental abruption*
- •2.2.4. placenta praevia
- •2.2.5. Cardiovascular instability (arterial blood pressure below 90 mm/Hg and heart rate greater than 100 bpm)
- •2.2.6. Clinical observation of microvascular oozing
- •* If in the event of a placental abruption, women may be recruited if there is less than
- •1000ml visible blood loss, because bleeding at the time of abruption maybe concealed.
- •3. Women can be included if they fulfil the inclusion criteria after delivery of the baby but
- •where the bleeding had started in the antenatal period (antepartum haemorrhage)
- •4. Women can be included where there is a slow accumulation of on-going blood loss (in the
- •first 12 hours after delivery) if they fulfil the inclusion criteria
排除标准
- •1. Women who have documented that they do not want to participate in the study during
- •the antenatal period
- •2. Women declining infusion of red blood cells or blood components
- •3. Known inherited bleeding disorder
- •4. Placenta accreta diagnosed antenatally
- •5. Women who have already received uterine brace sutures, uterine tamponade balloons,
- •radiology intervention or hysterectomy before entering the study
- •6. Clinical suspicion of amniotic fluid embolism
- •7. Secondary postpartum haemorrhage (haemorrhage which starts >12 hours after delivery)
研究者
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