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

Trials

Ann M Møller³  Birgit Bødker²  Mette Gøttge Madsen^1,10  Jeannet Lauenborg⁷  Lars Møller Pedersen¹  Ane Troelstrup¹  Jens Svare⁴  Anja U Mitchell³  Heidi Fosgrau Sharif⁸  Gabriele Hanke⁵  Kim Ekelund⁵  Charlotte Albrechtsen⁵  Jens Langhoff-Roos⁸  Jakob Stensballe⁶  Arash Afshari⁹  Anne Juul Wikkelsoe³ 

[1] Department of Anaesthesiology and Intensive Care Medicine, Copenhagen University Hospital, Kettegård allé 30, DK-2650, Hvidovre, Denmark;Department of Obstetrics and Gynaecology, Copenhagen University Hospital, Dyrehavevej 29, DK-3400, Hillerød, Denmark;Department of Anaesthesiology and Intensive Care Medicine, Copenhagen University Hospital, Herlev Ringvej 75, DK-2730, Herlev, Denmark;Department of Obstetrics and Gynaecology, Copenhagen University Hospital, Herlev Ringvej 75, DK-2730, Herlev, Denmark;Department of Anaesthesia, Mother and Children section, Juliane Marie Centre, Copenhagen University Hospital, Blegdamsvej 9, DK-2100 KBH Ø, Copenhagen, Rigshospitalet, Denmark;Department of Anaesthesiology, Centre of Head and Orthopaedics, and Section for Transfusion Medicine, Capital Region Blood Bank, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, DK-2100 KBH Ø, Copenhagen, Denmark;Department of Obstetrics and Gynaecology, Copenhagen University Hospital, Kettegård allé 30, DK-2650, Hvidovre, Denmark;Department of Obstetrics, Juliane Marie Centre, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, DK-2100 KBH Ø, Copenhagen, Denmark;Department of Infectious Disease Control and Prevention and Control, Geneva University Hospital, Rue Gabrielle-Perret-Gentil 4, CH-1211, Geneva, Switzerland;Department of Anaesthesiology and Intensive Care Medicine, Copenhagen University Hospital, Dyrehavevej 29, DK-3400, Hillerød, Denmark

关键词: Coagulation;    Thrombelastography;    Obstetrics;    Fibrinogen concentrate;    Blood transfusion;    Haemostasis;    Postpartum haemorrhage;   

Others  :  1095470
DOI  :  10.1186/1745-6215-13-110

 received in 2012-02-03, accepted in 2012-07-17,  发布年份 2012

【 摘 要 】

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 crossmatch. 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/Design

In this randomised placebo-controlled double-blind multicentre trial, parturients with primary PPH are eligible following vaginal delivery in case of: manual removal of placenta (blood loss ≥ 500 ml) or manual exploration of the uterus after the birth of placenta (blood loss ≥ 1000 ml). Caesarean sections are also eligible in case of perioperative blood loss ≥ 1000 ml. The exclusion criteria are known inherited haemostatic deficiencies, prepartum treatment with antithrombotics, pre-pregnancy weight <45 kg or refusal to receive blood transfusion. Following informed consent, patients are randomly allocated to either early treatment with 2 g fibrinogen concentrate or 100 ml isotonic saline (placebo). Haemostatic monitoring with standard laboratory coagulation tests and thromboelastography (TEG, functional fibrinogen and Rapid TEG) is performed during the initial 24 hours.

Primary outcome is the need for blood transfusion. To investigate a 33% reduction in the need for blood transfusion, a total of 245 patients will be included. Four university-affiliated public tertiary care hospitals will include patients during a two-year period. Adverse events including thrombosis are assessed in accordance with International Conference on Harmonisation (ICH) good clinical practice (GCP).

Discussion

A widespread belief in the benefits of early fibrinogen substitution in cases of PPH has led to increased off-label use. The FIB-PPH trial is investigator-initiated and aims to provide an evidence-based platform for the recommendations of the early use of fibrinogen concentrate in PPH.

Trial registration

ClincialTrials.gov NCT01359878.

【 授权许可】

   
2012 Wikkelsoe et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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