Pre-emptive treatment with fibrinogen concentrate for postpartum haemorrhage: randomized controlled trial.

Autor:	Wikkelsø AJ; Department of Anaesthesia and Intensive Care Medicine, Herlev Hospital, University of Copenhagen, Herlev Ringvej 75, Herlev DK-2730, Denmark wikkelso@gmail.com., Edwards HM; Department of Obstetrics and Gynaecology, Herlev Hospital, University of Copenhagen, Herlev Ringvej 75, Herlev DK-2730, Denmark., Afshari A; Department of Anaesthesia, Mother and Child Section, Juliane Marie Centre, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, KBH Ø DK-2100, Denmark., Stensballe J; Department of Anaesthesia, Centre of Head and Orthopaedics, and Section for Transfusion Medicine, Capital Region Blood Bank, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, KBH Ø DK-2100, Denmark., Langhoff-Roos J; Department of Obstetrics, Juliane Marie Centre, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, KBH Ø DK-2100, Denmark., Albrechtsen C; Department of Anaesthesia, Mother and Child Section, Juliane Marie Centre, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, KBH Ø DK-2100, Denmark., Ekelund K; Department of Anaesthesia, Mother and Child Section, Juliane Marie Centre, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, KBH Ø DK-2100, Denmark., Hanke G; Department of Anaesthesia, Mother and Child Section, Juliane Marie Centre, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, KBH Ø DK-2100, Denmark., Secher EL; Department of Anaesthesia, Mother and Child Section, Juliane Marie Centre, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, KBH Ø DK-2100, Denmark., Sharif HF; Department of Obstetrics, Juliane Marie Centre, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, KBH Ø DK-2100, Denmark., Pedersen LM; Department of Anaesthesia and Intensive Care Medicine, Hvidovre Hospital, University of Copenhagen, Kettegård Allé 30, DK-2650, Denmark., Troelstrup A; Department of Anaesthesia and Intensive Care Medicine, Hvidovre Hospital, University of Copenhagen, Kettegård Allé 30, DK-2650, Denmark., Lauenborg J; Department of Obstetrics and Gynaecology, Hvidovre Hospital, University of Copenhagen, Kettegård Allé 30, DK-2650, Denmark., Mitchell AU; Department of Anaesthesia and Intensive Care Medicine, Herlev Hospital, University of Copenhagen, Herlev Ringvej 75, Herlev DK-2730, Denmark., Fuhrmann L; Department of Anaesthesia and Intensive Care Medicine, Herlev Hospital, University of Copenhagen, Herlev Ringvej 75, Herlev DK-2730, Denmark., Svare J; Department of Obstetrics and Gynaecology, Herlev Hospital, University of Copenhagen, Herlev Ringvej 75, Herlev DK-2730, Denmark., Madsen MG; Department of Anaesthesia and Intensive Care Medicine, Hillerød Hospital, University of Copenhagen, Dyrehavevej 29, Hillerød DK-3400, Denmark., Bødker B; Department of Obstetrics and Gynaecology, Hillerød Hospital, University of Copenhagen, Dyrehavevej 29, Hillerød DK-3400, Denmark., Møller AM; Department of Anaesthesia and Intensive Care Medicine, Herlev Hospital, University of Copenhagen, Herlev Ringvej 75, Herlev DK-2730, Denmark.
Jazyk:	angličtina
Zdroj:	British journal of anaesthesia [Br J Anaesth] 2015 Apr; Vol. 114 (4), pp. 623-33. Date of Electronic Publication: 2015 Jan 13.
DOI:	10.1093/bja/aeu444
Abstrakt:	Background: In early postpartum haemorrhage (PPH), a low concentration of fibrinogen is associated with excessive subsequent bleeding and blood transfusion. We hypothesized that pre-emptive treatment with fibrinogen concentrate reduces the need for red blood cell (RBC) transfusion in patients with PPH. Methods: In this investigator-initiated, multicentre, double-blinded, parallel randomized controlled trial, we assigned subjects with severe PPH to a single dose of fibrinogen concentrate or placebo (saline). A dose of 2 g or equivalent was given to all subjects independent of body weight and the fibrinogen concentration at inclusion. The primary outcome was RBC transfusion up to 6 weeks postpartum. Secondary outcomes were total blood loss, total amount of blood transfused, occurrence of rebleeding, haemoglobin <58 g litre(-1), RBC transfusion within 4 h, 24 h, and 7 days, and as a composite outcome of 'severe PPH', defined as a decrease in haemoglobin of >40 g litre(-1), transfusion of at least 4 units of RBCs, haemostatic intervention (angiographic embolization, surgical arterial ligation, or hysterectomy), or maternal death. Results: Of the 249 randomized subjects, 123 of 124 in the fibrinogen group and 121 of 125 in the placebo group were included in the intention-to-treat analysis. At inclusion the subjects had severe PPH, with a mean blood loss of 1459 (sd 476) ml and a mean fibrinogen concentration of 4.5 (sd 1.2) g litre(-1). The intervention group received a mean dose of 26 mg kg(-1) fibrinogen concentrate, thereby significantly increasing fibrinogen concentration compared with placebo by 0.40 g litre(-1) (95% confidence interval, 0.15-0.65; P=0.002). Postpartum blood transfusion occurred in 25 (20%) of the fibrinogen group and 26 (22%) of the placebo group (relative risk, 0.95; 95% confidence interval, 0.58-1.54; P=0.88). We found no difference in any predefined secondary outcomes, per-protocol analyses, or adjusted analyses. No thromboembolic events were detected. Conclusions: We found no evidence for the use of 2 g fibrinogen concentrate as pre-emptive treatment for severe PPH in patients with normofibrinogenaemia. Clinical Trial Registration: ClinicalTrials.gov: http://clinicaltrials.gov/show/NCT01359878. Published protocol: http://www.trialsjournal.com/content/pdf/1745-6215-13-110.pdf. (© The Author 2015. Published by Oxford University Press on behalf of the British Journal of Anaesthesia. All rights reserved. For Permissions, please email: journals.permissions@oup.com.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu