Abstract
BackgroundPostpartum haemorrhage (PPH) is a major cause of maternal morbidity. Bleeding is caused by a combination of physical causes, such as failure of the uterus to contract or operations, and is made worse by impairment of the blood clotting system. A number of studies have shown that low levels of the blood clotting factor fibrinogen are associated with progression of bleeding, the need for invasive interventions and transfusions of red blood cells and fresh frozen plasma (FFP). This trial will investigate whether early infusion of fibrinogen concentrate during a major PPH, with the aim of correcting a low fibrinogen to a level that is normal for delivery, based on the Fibtem test, reduces the total number of allogeneic blood products (red blood cells, FFP, cryoprecipitate and platelets) transfused after study medication until discharge, compared to placebo.Methods/designThis is a prospective, randomised, double-blind placebo controlled trial. Women will enter an observational phase and if their Fibtem levels fall they will be randomised in the interventional phase. A total of 60 women will be randomised and women are eligible for the trial if they meet all of the following inclusion criteria: age 18 years or over, gestation ≥24 + 0 weeks, haemorrhage of about 1500 ml and on-going bleeding without another complication or haemorrhage of about 1000 ml and caesarean section/uterine atony/placental abruption/placenta praevia/cardiovascular instability or microvascular oozing. Participants with a Fibtem A5 < 16 mm will be randomly allocated to receive either a bolus infusion of fibrinogen concentrate or placebo (isotonic saline). The dose of fibrinogen concentrate or placebo will be calculated based on the woman’s ideal body weight for height and the measured Fibtem A5 with the aim of increasing the Fibtem A5 to 23 mm.DiscussionThe trial aims to provide evidence on the efficacy and safety of fibrinogen concentrate during acute bleeding in an obstetric setting.Trial registrationISRCTN ref: ISRCTN46295339 (01.07.2013); EudraCT: 2012-005511-11 (28.11.2012), UKCRN ref: 13940.
Highlights
Postpartum haemorrhage (PPH) is a major cause of maternal morbidity
The aim of this study is to investigate whether infusion of fibrinogen concentrate, based on the Fibtem after 5 min (A5) test, during a moderately severe PPH reduces the total number of allogeneic blood products transfused after study medication until discharged compared to placebo
Postpartum haemorrhage is a major cause of maternal morbidity and mortality
Summary
Postpartum haemorrhage is a major cause of maternal morbidity and mortality. Fibrinogen appears to be a useful biomarker to predict the progression from moderate to massive PPH and the need for blood transfusion; it is not known whether replacement of fibrinogen to levels normal for the peripartum period (4–6 g/l), during an ongoing PPH, would reduce bleeding and the need for transfusion. Fibrinogen concentrate is not licensed for use in obstetric haemorrhage in the UK, it has been used off-label to correct hypofibrinogenaemia [17] and is the recommended treatment in other countries [25] This trial is designed to detect haemostatic impairment rapidly and early during major PPH, identified by a near patient Fibtem A5 test below 16 mm, and replace fibrinogen to a level within the lower end of the normal range associated with delivery. The primary objective is to investigate whether infusion of fibrinogen, based on a Fibtem A5 test, during a moderately severe PPH reduces the total number of allogeneic blood products (FFP, red blood cells, platelet concentrates and cryoprecipitate) transfused after study medication until discharge compared to placebo. Read and approved the final version of the manuscript
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