Efficacy and safety of recombinant factor XIII on reducing blood transfusions in cardiac surgery: A randomized, placebo-controlled, multicenter clinical trial

Karkouti, Keyvan; Heymann, Christian von; Jespersen, Christian M.; Korte, Wolfgang; Levy, Jerrold H.; Ranucci, Marco; Sellke, Frank W.; Song, Howard K.

doi:10.1016/j.jtcvs.2013.04.044

Cited by 73 publications

(53 citation statements)

References 25 publications

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“…A recent RCT has shown that recombinant factor XIII administration does not reduce bleeding or transfusion rates. 162 A consistent finding in all studies is the association between low fibrinogen concentrations and bleeding. In a study in 4202 cardiac surgery patients, Karkouti et al 163 observed a fibrinogen threshold of 2 g/dl below which blood loss increased.…”

Section: Laboratory Reference Testssupporting

confidence: 59%

“…For example, enrolment of a patient cohort at mixed risk of bleeding and transfusion in two recent multicentre cardiac surgery RCTs, one evaluating antifibrinolytics and another recombinant factor XII, is considered to have significantly influenced the results of these trials. 8,162,191 The LVBT risk score described in the current study provides a simple transparent technique for cohort enrichment in clinical trials in cardiac surgery. Our risk score, which is available as an e-calculator, may also be used by clinicians to accurately risk assess individual patients, a class I recommendation in recent cardiac surgery blood management guidelines.…”

Section: Clinical Utilitymentioning

confidence: 99%

See 1 more Smart Citation

Diagnostic and therapeutic medical devices for safer blood management in cardiac surgery: systematic reviews, observational studies and randomised controlled trials

Murphy

Mumford

Rogers

et al. 2017

Programme Grants Appl Res

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This report should be referenced as follows:Murphy GJ, Mumford AD, Rogers CA, Wordsworth S, Stokes EA, Verheyden V, et al. Diagnostic and therapeutic medical devices for safer blood management in cardiac surgery: systematic reviews, observational studies and randomised controlled trials. Programme Grants Appl Res 2017;5(17). Programme Grants for Applied ResearchISSN 2050-4322 (Print) ISSN 2050-4330 (Online) This journal is a member of and subscribes to the principles of the Committee on Publication Ethics (COPE) (www.publicationethics.org/).Editorial contact: journals.library@nihr.ac.ukThe full PGfAR archive is freely available to view online at www.journalslibrary.nihr.ac.uk/pgfar. Print-on-demand copies can be purchased from the report pages of the NIHR Journals Library website: www.journalslibrary.nihr.ac.uk Criteria for inclusion in the Programme Grants for Applied Research journalReports are published in Programme Grants for Applied Research (PGfAR) if (1) they have resulted from work for the PGfAR programme, and (2) they are of a sufficiently high scientific quality as assessed by the reviewers and editors. Programme Grants for Applied Research programmeThe Programme Grants for Applied Research (PGfAR) programme, part of the National Institute for Health Research (NIHR), was set up in 2006 to produce independent research findings that will have practical application for the benefit of patients and the NHS in the relatively near future. The Programme is managed by the NIHR Central Commissioning Facility (CCF) with strategic input from the Programme Director.The programme is a national response mode funding scheme that aims to provide evidence to improve health outcomes in England through promotion of health, prevention of ill health, and optimal disease management (including safety and quality), with particular emphasis on conditions causing significant disease burden.For more information about the PGfAR programme please visit the website: http://www.nihr.ac.uk/funding/programme-grants-forapplied-research.htm This reportThe research reported in this issue of the journal was funded by PGfAR as project number RP-PG-0407-10384. The contractual start date was in July 2008. The final report began editorial review in July 2016 and was accepted for publication in April 2017. As the funder, the PGfAR programme agreed the research questions and study designs in advance with the investigators. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The PGfAR editors and production house have tried to ensure the accuracy of the authors' report and would like to thank the reviewers for their constructive comments on the final report document. However, they do not accept liability for damages or losses arising from material published in this report.This report presents independent research funded by the National Institute for Health Research (NIHR). The views and opinions expressed by authors in this publication are those of the authors and do not ...

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Section: Laboratory Reference Testssupporting

confidence: 59%

Section: Clinical Utilitymentioning

confidence: 99%

Diagnostic and therapeutic medical devices for safer blood management in cardiac surgery: systematic reviews, observational studies and randomised controlled trials

Murphy

Mumford

Rogers

et al. 2017

Programme Grants Appl Res

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“…Some might consider transfusion as a surrogate for perioperative bleeding, e.g., in studies exploring the effects of hemostatic drugs or techniques. 18,30 Nevertheless, even in this setting, some important methodological points must be considered. The most important consideration is that transfusions in cardiac surgery patients may be triggered by factors other than directly from bleeding-e.g., preoperative anemia and intraoperative hemodilution.…”

Section: Transfusions As Quality Of Care Measuresmentioning

confidence: 99%

“…To limit the effects of these confounders, some RCTs have successfully introduced strict exclusion criteria based on preoperative anemia and/or very low body surface area as well as withdrawal criteria in case of excessive hemodilution during CPB. 18,30 In addition, whenever transfusions are the primary endpoint in an RCT, a well-defined transfusion protocol needs to be strictly followed with few protocol deviations.…”

Section: Transfusions As Quality Of Care Measuresmentioning

confidence: 99%

Outcome measures and quality markers for perioperative blood loss and transfusion in cardiac surgery

Ranucci

2015

Can J Anesth/J Can Anesth

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“…In a randomised controlled trial of recombinant factor XIII vs placebo, there was no therapeutic benefit on transfusion avoidance, transfusion requirements or operative revision, despite an observed correction of factor XIII levels. Factor XIII administration outside clinical trials should therefore be discouraged [67][68][69][70][71].…”

Section: Factor XIIImentioning

confidence: 99%

Haemostatic management of cardiac surgical haemorrhage

2014

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SummaryAlmost 30 000 cardiopulmonary bypass operations are performed in the UK every year, consuming a considerable portion of the UK blood supply. Each year, in cardiac surgery, 90% of blood products are used by only 10% of patients, and over the past 25 years, much innovation and research has gone into improving peri-operative diagnosis and therapy for these patients. Visco-elastic tests performed at the bedside, with modifications to allow direct quantification of fibrinogen levels, are probably the biggest advancement. There is no clear advantage of thromboelastometry over thromboelastography, and the published literature remains scarce. Visco-elastic testing has recently been coupled with the systematic replacement of clotting factors by means of factor concentrates, with objective improvement in terms of blood loss, red blood cell usage and surgical re-exploration. The National Institute for Health and Care Excellence has reviewed the available evidence and recommended visco-elastic tests as cost effective in cardiac surgery. Factor concentrates, however, carry significant risks, particularly unnecessary donor exposures, potential selective over-correction of partial deficiencies and the possibility that the postoperative risk of venous thromboembolism is increased; as yet there are no data on risk-benefit analysis. There are a number of promising drugs used in topical haemostasis, but the requirement to apply these before major bleeding is manifest limits their use considerably. Hyperfibrinolysis is less important than in the past due to the wide spread adoption of antifibrinolytic agents and close intra-operative monitoring of heparin effect.

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Efficacy and safety of recombinant factor XIII on reducing blood transfusions in cardiac surgery: A randomized, placebo-controlled, multicenter clinical trial

Abstract: Replenishment of FXIII levels after cardiopulmonary bypass had no effect on transfusion avoidance, transfusion requirements, or reoperation in moderate-risk cardiac surgery patients (ClinicalTrials.gov identifier: NCT00914589).

Cited by 73 publications

References 25 publications

Diagnostic and therapeutic medical devices for safer blood management in cardiac surgery: systematic reviews, observational studies and randomised controlled trials

Diagnostic and therapeutic medical devices for safer blood management in cardiac surgery: systematic reviews, observational studies and randomised controlled trials

Outcome measures and quality markers for perioperative blood loss and transfusion in cardiac surgery

Haemostatic management of cardiac surgical haemorrhage

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