ArticleBlood transfusion = Trasfusione del sangue2015
The Australian and New Zealand Haemostasis Registry: ten years of data on off-licence use of recombinant activated factor VII.
Article in Blood transfusion = Trasfusione del sangue, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
13 citing papers in PubMed, 32 citations in OpenAlex.
- Rationale for the Potential Use of Recombinant Activated Factor VII in Severe Post-Partum Hemorrhage.Journal of clinical medicine · 2024Article
- Efficacy and Safety Analyses of Recombinant Factor VIIa in Severe Post-Partum Hemorrhage.Journal of clinical medicine · 2024Article
- Perioperative Considerations in Management of the Severely Bleeding Coagulopathic Patient.Anesthesiology · 2023Article
- The European guideline on management of major bleeding and coagulopathy following trauma: fifth edition.Critical care (London, England) · 2019Article
- Assessing the effect of risk factors on rates of obstetric transfusion over time using two methodological approaches.BMC medical research methodology · 2018Article
- Observational studies and their utility for practice.Australian prescriber · 2018Review
- Peripartum Haemorrhage: Haemostatic Aspects of the New German PPH Guideline.Transfusion medicine and hemotherapy : offizielles Organ der Deutschen Gesellschaft fur Transfusionsmedizin und Immunhamatologie · 2018Review
- Improving outcomes for hospital patients with critical bleeding requiring massive transfusion: the Australian and New Zealand Massive Transfusion Registry study methodology.BMC research notes · 2016Article
- Recombinant activated factor VII for uncontrolled bleeding postcardiac surgery.Journal of the Saudi Heart Association · 2016Article
- The European guideline on management of major bleeding and coagulopathy following trauma: fourth edition.Critical care (London, England) · 2016Article
- Successful use of recombinant activated factor VII (eptacog alfa, Novoseven®) in a refractory bleeding during pediatric cardiac surgery: a case report.JA clinical reports · 2015Article
- Liver trauma: WSES position paper.World journal of emergency surgery : WJES · 2015Article
- 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.Annals of cardiac anaesthesiaObservational
Corrections and comments
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Authors and funding
8 authors at 5 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundRecombinant 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
methodsThe 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.
resultsThe 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.
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