Literature DB >> 19923520

Recombinant activated factor VII in obstetric hemorrhage: experiences from the Australian and New Zealand Haemostasis Registry.

Louise E Phillips1, Claire McLintock, Wendy Pollock, Stephen Gatt, Philip Popham, Gary Jankelowitz, Robert Ogle, Peter A Cameron.   

Abstract

OBJECTIVE: Through the Australian and New Zealand Haemostasis Registry, we report on the Australian and New Zealand experience with recombinant activated factor VII (rFVIIa) in obstetric patients.
METHODS: The role of rFVIIa for off-label indications, including trauma, cardiac surgery, and severe postpartum hemorrhage, remains controversial. The Haemostasis Registry established by Monash University in Melbourne, Australia monitors off-label use of rFVIIa across Australia and New Zealand. The purpose of this study was to summarize Registry data for all obstetric hemorrhage patients treated with rFVIIa at participating hospitals between January 2002 and July 2008. The primary outcome measures were reduction or cessation of bleeding (positive therapeutic response), mortality, and hysterectomy rate.
RESULTS: During the study period, the Registry received data for 2128 patients. This included 110 cases of administration of rFVIIa in obstetric patients from 38 hospitals, comprising 5% of the total Registry population, 105 of whom were treated for acute hemorrhage. Women received median (interquartile range) individual doses of 92 microg/kg (73-100) of rFVIIa (median total dose 92 microg/kg [58-108]), and 78% of patients received a single dose. The positive response rate to rFVIIa was 76% with 64% responding to the first dose. Ninety-one percent of women were alive at 28 days. Forty-three women (41%) underwent hysterectomy before receiving rFVIIa and, of those remaining, 13 (21%) required hysterectomy after rFVIIa therapy. Two thromboembolic events (1 pulmonary embolism and 1 deep venous thrombosis) and 1 case of hypoxic-ischemic encephalopathy resulting from severe anoxia were reported.
CONCLUSIONS: The reported effect of rFVIIa in many, but not all, obstetric cases was positive. There was no mortality as a result of thromboembolic complications. Randomized, controlled trials are required to confirm its safety and efficacy and to assess the possibility that use at an earlier stage in treatment of severe postpartum hemorrhage may avoid the need to resort to postpartum hysterectomy for control of bleeding, thus preserving fertility.

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Year:  2009        PMID: 19923520     DOI: 10.1213/ANE.0b013e3181c039e6

Source DB:  PubMed          Journal:  Anesth Analg        ISSN: 0003-2999            Impact factor:   5.108


  12 in total

1.  Recombinant activated factor VII (rFVIIa/NovoSeven®) in the management of severe postpartum haemorrhage: initial report of a multicentre case series in Japan.

Authors:  Takao Kobayashi; Masao Nakabayashi; Akira Yoshioka; Makoto Maeda; Tsuyomu Ikenoue
Journal:  Int J Hematol       Date:  2011-12-09       Impact factor: 2.490

Review 2.  National and International Guidelines for Patient Blood Management in Obstetrics: A Qualitative Review.

Authors:  Ruth Shaylor; Carolyn F Weiniger; Naola Austin; Alexander Tzabazis; Aryeh Shander; Lawrence T Goodnough; Alexander J Butwick
Journal:  Anesth Analg       Date:  2017-01       Impact factor: 5.108

3.  Patient blood management in obstetrics: prevention and treatment of postpartum haemorrhage. A NATA consensus statement.

Authors:  Manuel Muñoz; Jakob Stensballe; Anne-Sophie Ducloy-Bouthors; Marie-Pierre Bonnet; Edoardo De Robertis; Ino Fornet; François Goffinet; Stefan Hofer; Wolfgang Holzgreve; Susana Manrique; Jacky Nizard; François Christory; Charles-Marc Samama; Jean-François Hardy
Journal:  Blood Transfus       Date:  2019-02-06       Impact factor: 3.443

4.  Use of Activated Recombinant Factor VII in Severe Bleeding - Evidence for Efficacy and Safety in Trauma, Postpartum Hemorrhage, Cardiac Surgery, and Gastrointestinal Bleeding.

Authors:  Philip Lau; Victor Ong; Wah Tze Tan; Pei Lin Koh; Mikael Hartman
Journal:  Transfus Med Hemother       Date:  2012-03-29       Impact factor: 3.747

Review 5.  Acute Fatty Liver of Pregnancy: Pathophysiology, Anesthetic Implications, and Obstetrical Management.

Authors:  Emily E Naoum; Lisa R Leffert; Hovig V Chitilian; Kathryn J Gray; Brian T Bateman
Journal:  Anesthesiology       Date:  2019-03       Impact factor: 7.892

6.  The Australian and New Zealand Haemostasis Registry: ten years of data on off-licence use of recombinant activated factor VII.

Authors:  Amanda Zatta; Zoe Mcquilten; Rangi Kandane-Rathnayake; James Isbister; Scott Dunkley; John Mcneil; Peter Cameron; Louise Phillips
Journal:  Blood Transfus       Date:  2014-06-05       Impact factor: 3.443

7.  Preliminary experience with use of recombinant activated factor VII to control postpartum hemorrhage in acute fatty liver of pregnancy and other pregnancy-related liver disorders.

Authors:  Ashish Goel; Sukesh Chandran Nair; Auro Viswabandya; Vinodh P Masilamani; Shoma V Rao; Alice George; Annie Regi; Ruby Jose; Uday Zachariah; Kandasamy Subramani; C E Eapen; George Chandy
Journal:  Indian J Gastroenterol       Date:  2013-03-10

8.  [Anesthesia in obstetrics: Tried and trusted methods, current standards and new challenges].

Authors:  P Kranke; T Annecke; D H Bremerich; R Hanß; L Kaufner; C Klapp; H Ohnesorge; U Schwemmer; T Standl; S Weber; T Volk
Journal:  Anaesthesist       Date:  2016-01       Impact factor: 1.041

Review 9.  Peripartum Haemorrhage: Haemostatic Aspects of the New German PPH Guideline.

Authors:  Heiko Lier; Christian von Heymann; Wolfgang Korte; Dietmar Schlembach
Journal:  Transfus Med Hemother       Date:  2017-11-15       Impact factor: 3.747

Review 10.  Strategies for blood conservation in pediatric cardiac surgery.

Authors:  Sarvesh Pal Singh
Journal:  Ann Card Anaesth       Date:  2016 Oct-Dec
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