The Australian and New Zealand Haemostasis Registry: Ten Years of Data on Off-licence Use of Recombinant Activated Factor VII

Overview

Journal Blood Transfus

Specialty Hematology

Date 2014 Jun 25

PMID 24960661

Citations 13

Authors

Amanda Zatta

Zoe McQuilten

Rangi Kandane-Rathnayake

James Isbister

Scott Dunkley

John McNeil

Peter Cameron

Louise Phillips

Affiliations

Soon will be listed here.

Abstract

Background: Recombinant activated factor VII (rFVIIa) has been widely used as an off-licence pan-haemostatic agent in patients with critical bleeding. However, outside the trauma setting, there is relatively little high quality evidence on the risks and benefits of this agent. The Haemostasis Registry was established to investigate the extent of use, dosing, safety and outcomes of patients after off-licence rFVIIa treatment of critical bleeding.

Materials And Methods: The Registry recruited non-haemophiliac patients treated with rFVIIa from 2000-2009 (inclusive) in Australia and New Zealand. Detailed information was gathered on patients' demographics, context of bleeding, rFVIIa administration, laboratory results, blood component and other therapies, and outcomes. Outcome measures included subjectively assessed effect of rFVIIa on bleeding (response), adverse events (thromboembolic and other) and 28-day mortality.

Results: The registry included 3,446 cases in 3,322 patients (median [IQR] age 56 [33-70] years, 65% (n=2,147) male). Clinical indications included cardiac surgery (45%), other surgery (18%), trauma (13%), medical bleeding (6%), liver disease (6%), and obstetric haemorrhage (5%). The median [IQR] dose was 91 [72-103] μg/kg and 77% received a single dose. Reduction or cessation of bleeding was reported in 74% and 28-day survival was 71% but outcomes varied depending on clinical context. pH strongly correlated with outcome measures; 81% of patients with pH <7.1 died. Approximately 11% of patients had thromboembolic adverse events. In multivariate analysis, pH prior to administration and bleeding context were independently associated with reported response to rFVIIa and 28-day mortality.

Discussion: The Haemostasis Registry is the largest dataset of its kind and provides observational data on the off-licence use of rFVIIa over a 10-year period. It has been an invaluable resource for rigorously tracking adverse events and helping to inform clinical practice.

Citing Articles

Rationale for the Potential Use of Recombinant Activated Factor VII in Severe Post-Partum Hemorrhage.

Acs N, Korte W, von Heymann C, Windyga J, Blatny J J Clin Med. 2024; 13(10).

PMID: 38792469 PMC: 11122570. DOI: 10.3390/jcm13102928.

Efficacy and Safety Analyses of Recombinant Factor VIIa in Severe Post-Partum Hemorrhage.

Caram-Deelder C, McKinnon Edwards H, Zdanowicz J, van den Akker T, Birkegard C, Blatny J J Clin Med. 2024; 13(9).

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Perioperative Considerations in Management of the Severely Bleeding Coagulopathic Patient.

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Adequacy of hemostatic resuscitation improves therapeutic efficacy of recombinant activated factor VII and reduces reexploration rate for bleeding in postoperative cardiac surgery patients with refractory hemorrhage.

Feih J, Juul J, Rinka J, Kreuziger L, Pagel P, Tawil J Ann Card Anaesth. 2019; 22(4):388-393.

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The European guideline on management of major bleeding and coagulopathy following trauma: fifth edition.

Spahn D, Bouillon B, Cerny V, Duranteau J, Filipescu D, Hunt B Crit Care. 2019; 23(1):98.

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