TY - JOUR

T1 - The FIB-PPH trial

T2 - fibrinogen concentrate as initial treatment for postpartum haemorrhage: study protocol for a randomised controlled trial

AU - Wikkelsoe, Anne J

AU - Afshari, Arash

AU - Stensballe, Jakob

AU - Langhoff-Roos, Jens

AU - Albrechtsen, Charlotte

AU - Ekelund, Kim

AU - Hanke, Gabriele

AU - Sharif, Heidi

AU - Mitchell, Anja U

AU - Svare, Jens

AU - Troelstrup, Ane

AU - Pedersen, Lars Møller

AU - Lauenborg, Jeannet

AU - Gøttge, Mette

AU - Bødker, Birgit

AU - Moeller, Ann M

PY - 2012

Y1 - 2012

N2 - ABSTRACT: BACKGROUND: Postpartum haemorrhage (PPH) remains a leading cause of maternal mortality worldwide. In Denmark 2 % of parturients receive blood transfusion. During the course of bleeding fibrinogen (coagulation factor I) may be depleted and fall to critically low levels impairing haemostasis and thus worsening the ongoing bleeding. A plasma level of fibrinogen below 2 g/L in the early phase of postpartum haemorrhage is associated with subsequent development of severe haemorrhage. Use of fibrinogen concentrate allows high-dose substitution without the need for blood type cross match. So far no publications of randomised controlled trials involving acutely bleeding patients in the obstetrical setting have been published. This trial aims to investigate if early treatment with fibrinogen concentrate reduces the need for blood transfusion in women suffering severe PPH. METHODS: In this randomised placebo controlled double blind multicenter trial, parturients with primary PPH are eligible following vaginal delivery in case of: Manual removal of placenta (blood loss [greater than or equal to] 500 ml) or manual exploration of the uterus after the birth of placenta (blood loss [greater than or equal to] 1000 ml). Caesarean sections are also eligible in case of perioperative blood loss [greater than or equal to] 1000 ml. The exclusion criteria are known inherited haemostatic deficiencies, prepartum treatment with anti-thrombotics, pre-pregnancy weight

AB - ABSTRACT: BACKGROUND: Postpartum haemorrhage (PPH) remains a leading cause of maternal mortality worldwide. In Denmark 2 % of parturients receive blood transfusion. During the course of bleeding fibrinogen (coagulation factor I) may be depleted and fall to critically low levels impairing haemostasis and thus worsening the ongoing bleeding. A plasma level of fibrinogen below 2 g/L in the early phase of postpartum haemorrhage is associated with subsequent development of severe haemorrhage. Use of fibrinogen concentrate allows high-dose substitution without the need for blood type cross match. So far no publications of randomised controlled trials involving acutely bleeding patients in the obstetrical setting have been published. This trial aims to investigate if early treatment with fibrinogen concentrate reduces the need for blood transfusion in women suffering severe PPH. METHODS: In this randomised placebo controlled double blind multicenter trial, parturients with primary PPH are eligible following vaginal delivery in case of: Manual removal of placenta (blood loss [greater than or equal to] 500 ml) or manual exploration of the uterus after the birth of placenta (blood loss [greater than or equal to] 1000 ml). Caesarean sections are also eligible in case of perioperative blood loss [greater than or equal to] 1000 ml. The exclusion criteria are known inherited haemostatic deficiencies, prepartum treatment with anti-thrombotics, pre-pregnancy weight

U2 - 10.1186/1745-6215-13-110

DO - 10.1186/1745-6215-13-110

M3 - Journal article

VL - 13

SP - 110

JO - Trials

JF - Trials

SN - 1745-6215

IS - 1

ER -