Fibrinogen concentrate versus placebo for treatment of postpartum haemorrhage: a prospective double blind randomised control trial - Fibrinogen concentrate to treat postpartum haemorrhage

RACD Cardiff University0 个研究点目标入组 57 人开始时间: 2013年3月15日最近更新: 2019年6月30日

适应症

试验速览

暂无简介。

•Inclusion criteria 1) Women Age 18 years or over 2) Women should have any one of the following within the first 12 hours after delivery: a) Haemorrhage of about 1500 mL and ongoing bleeding without another complication or b) Haemorrhage of about 1000 mL and ongoing bleeding with any of: i. caesarean section ii. uterine atony iii. placental abruption iv. placenta praevia v. Cardiovascular instability (arterial blood pressure below 90mm/Hg and heart rate greater than 100 bpm) vi. Clinical observation of microvascular oozing NB. Women can be included if they fulfill the inclusion criteria after delivery of the baby but where the bleeding had started in the antenatal period (antepartum haemorrhage). Women can be included where there is a slow accumulation of on-going blood loss (in the first 12 hours after delivery) if they fulfill the inclusion criteria. Participants will be eligible for randomisation and entry into the interventional phase of the study if there are both • On-going bleeding and • FIBTEM MCF < 18mm
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 1050
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•Exclusion criteria The following groups will be excluded: 1) Women who have stated 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)

发起方

RACD Cardiff University