TY - JOUR
T1 - Fibrinogen concentrate versus placebo for treatment of postpartum haemorrhage
T2 - Study protocol for a randomised controlled trial
AU - Aawar, Nadine
AU - Alikhan, Raza
AU - Bruynseels, Daniel
AU - Cannings-John, Rebecca
AU - Collis, Rachel
AU - Dick, John
AU - Elton, Christopher
AU - Fernando, Roshan
AU - Hall, Judith
AU - Hood, Kerry
AU - Lack, Nicki
AU - Mallaiah, Shuba
AU - Maybury, Helena
AU - Nuttall, Jacqueline
AU - Paranjothy, Shantini
AU - Rayment, Rachel
AU - Rees, Alexandra
AU - Sanders, Julia
AU - Townson, Julia
AU - Weeks, Andrew
AU - Collins, Peter
N1 - Funding Information:
The Rotem machines and reagents used in the trial are loaned without charge by TEM International. TEM International had no role in the study design, data collection and analysis, decision to publish or preparation of the study protocol. The trial is funded by a grant from CSL Behring to Cardiff University. Peter Collins has received honoraria for talks at symposia funded by CSL Behring and acted as a paid consultant to CSL Behring on the subject of postpartum haemorrhage. Rachel Collis has received honoraria for talks at symposia funded by CSL Behring.
Publisher Copyright:
© Aawar et al.; licensee BioMed Central.
PY - 2015/4/17
Y1 - 2015/4/17
N2 - Background: Postpartum 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/design: This 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. Discussion: The trial aims to provide evidence on the efficacy and safety of fibrinogen concentrate during acute bleeding in an obstetric setting.
AB - Background: Postpartum 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/design: This 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. Discussion: The trial aims to provide evidence on the efficacy and safety of fibrinogen concentrate during acute bleeding in an obstetric setting.
KW - Postpartum haemorrhage
KW - Blood transfusion
KW - Fibrinogen concentrate
KW - Fibtem
UR - http://www.scopus.com/inward/record.url?scp=84928573515&partnerID=8YFLogxK
U2 - 10.1186/s13063-015-0670-9
DO - 10.1186/s13063-015-0670-9
M3 - Article
C2 - 25906770
VL - 16
SP - 1
EP - 11
JO - Trials
JF - Trials
SN - 1745-6215
IS - 1
M1 - 169
ER -