Point-of-Care Hemostatic Testing in Cardiac Surgery

Karkouti, Keyvan; Callum, Jeannie; Wijeysundera, Duminda N.; Rao, Vivek; Crowther, Mark; Grocott, Hilary P.; Pinto, Ruxandra; Scales, Damon C.; Investigators, Tacs

doi:10.1161/circulationaha.116.023956

Cited by 236 publications

(65 citation statements)

References 43 publications

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“…Fifteen trials that randomised a total of 8737 participants met the inclusion criteria and were included in the analysis. 112,129,[135][136][137][138][139][140][141][142][143][144][145][146][147] Two of the included studies were published in abstract form. 139,144 The two review authors (GJM, GFS) were in agreement on the selection of included studies.…”

Section: Resultsmentioning

confidence: 99%

“…5 NO. 17 multicentre trial that enrolled 7402 participants in 12 Canadian hospitals and which was published in 2016, 129 we assessed important clinical outcomes including mortality, kidney injury, stroke and prolonged respiratory support and we summarised the evidence using the GRADE approach.…”

Section: Aims and Objectivesmentioning

confidence: 99%

“…Of the 15 trials identified in our search, 13 enrolled adults undergoing CABG (n = 2), 135,136 mixed cardiac surgery (n = 10), 112,129,139,140,[142][143][144][145][146][147] or surgery on the thoracic aorta (n = 1) 138 and two enrolled children undergoing surgery for congenital disease. 137,141 The sample size ranged from 22 143 to 7402 129 participants.…”

Section: Included Studiesmentioning

confidence: 99%

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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: Resultsmentioning

confidence: 99%

Section: Aims and Objectivesmentioning

confidence: 99%

Section: Included Studiesmentioning

confidence: 99%

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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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“…The MEA platelet function analyzer ADP‐test and ASPI‐test results measures platelet dysfunction associated with P2Y 12 blockers and aspirin, respectively 28. The EXTEM maximum clot firmness ‐ FIBTEM maximum clot firmness and TRAP‐test results were selected to measure global platelet dysfunction function 11, 16. Test results were incorporated into predictive models for CCB as continuous variable.…”

Section: Methodsmentioning

confidence: 99%

“…Several small, single‐center, randomized controlled trials (RCTs) in cardiac surgery have shown that when compared to conventional laboratory testing or clinician judgement alone, near‐patient testing reduced transfusion of RBC10, 11 or non‐RBC blood components 10, 11, 12, 13, 14, 15. In a multicenter RCT of more than 7400 patients, implementation of a blood management algorithm incorporating near‐patient tests, resulted in reduced RBC transfusion, platelet transfusion and overall bleeding 16. In this trial, near‐patient test results were used to direct targeted treatments for coagulopathy only in patients who had already developed severe bleeding 16…”

Section: Introductionmentioning

confidence: 99%

Near‐patient coagulation testing to predict bleeding after cardiac surgery: a cohort study

Mumford

Harris

Plummer

et al. 2017

Research and Practice in Thrombosis and Haemostasis

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Essentials Near‐patient testing improves coagulopathy diagnosis in cardiac surgery patients with severe bleeding.We investigated how well pre‐emptive near‐patient testing predicted severe bleeding.Severe bleeding could be predicted using both near‐patient tests and patient clinical characteristics.Near‐patient test results gave little additional predictive value over clinical characteristics alone. BackgroundCoagulopathic bleeding is common after cardiac surgery and is associated with increased morbidity, mortality and healthcare costs. Implementation of blood management algorithms in which patients with severe bleeding undergo near‐patient coagulation testing results in less overall bleeding and transfusion. However, it is unknown whether there is additional value from pre‐emptive near‐patient testing to predict whether severe bleeding will occur.ObjectivesTo evaluate how well a comprehensive panel of 28 near‐patient platelet and viscoelastometry tests predict bleeding after cardiac surgery, compared to prediction using baseline clinical characteristics alone.MethodsSingle‐center, prospective cohort study in adults undergoing a range of cardiac surgery procedures. The primary outcome was clinical concern about bleeding (CCB), a composite of high blood loss (chest drain volume >600 mL within 6 hours), re‐operation for bleeding or administration of a pro‐haemostatic treatment directed by clinician judgement.ResultsIn 1833 patients recruited between March 2010 and August 2012, the median number of abnormal near‐patient test results was 5/28 per patient (range 0‐18). CCB occurred in 449/1833 patients (24.5%). The c‐statistic for a predictive model for CCB using only baseline clinical characteristics (baseline‐only model) was 0.72 (95% CI 0.69‐0.75). Addition of near‐patient test results to this model (baseline‐plus‐test model) improved the prediction of CCB (c‐statistic 0.75 [0.72‐0.77]), but increased the number of correctly classified patients by only 18 (0.98%).ConclusionsNear‐patient coagulation testing predicts bleeding in cardiac surgery patients, but offers little improvement in prediction compared to baseline clinical characteristics alone. trial registration: ISRNCTN 20778544 (http://www.isrctn.com/).

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Effect of Fibrinogen Concentrate vs Cryoprecipitate on Blood Component Transfusion After Cardiac Surgery

Callum

Farkouh

Scales

et al. 2019

JAMA

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107

128

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IMPORTANCE Excessive bleeding is a common complication of cardiac surgery. An important cause of bleeding is acquired hypofibrinogenemia (fibrinogen level <1.5-2.0 g/L), for which guidelines recommend fibrinogen replacement with cryoprecipitate or fibrinogen concentrate. The 2 products have important differences, but comparative clinical data are lacking.OBJECTIVE To determine if fibrinogen concentrate is noninferior to cryoprecipitate for treatment of bleeding related to hypofibrinogenemia after cardiac surgery. DESIGN, SETTING, AND PARTICIPANTSRandomized clinical trial at 11 Canadian hospitals enrolling adult patients experiencing clinically significant bleeding and hypofibrinogenemia after cardiac surgery (from February 10, 2017, to November 1, 2018). Final 28-day follow-up visit was completed on November 28, 2018.INTERVENTIONS Fibrinogen concentrate (4 g; n = 415) or cryoprecipitate (10 units; n = 412) for each ordered dose within 24 hours after cardiopulmonary bypass. MAIN OUTCOMES AND MEASURESPrimary outcome was blood components (red blood cells, platelets, plasma) administered during 24 hours post bypass. A 2-sample, 1-sided test for the ratio of the mean number of units was conducted to evaluate noninferiority (threshold for noninferiority ratio, <1.2). RESULTSOf 827 randomized patients, 735 (372 fibrinogen concentrate, 363 cryoprecipitate) were treated and included in the primary analysis (median age, 64 [interquartile range, 53-72] years; 30% women; 72% underwent complex operations; 95% moderate to severe bleeding; and pretreatment fibrinogen level, 1.6 [interquartile range, 1.3-1.9] g/L). The trial met the a priori stopping criterion for noninferiority at the interim analysis after 827 of planned 1200 patients were randomized. Mean 24-hour postbypass allogeneic transfusions were 16.3 (95% CI, 14.9 to 17.8) units in the fibrinogen concentrate group and 17.0 (95% CI, 15.6 to 18.6) units in the cryoprecipitate group (ratio, 0.96 [1-sided 97.5% CI, −ϱ to 1.09; P < .001 for noninferiority] [2-sided 95% CI, 0.84 to 1.09; P = .50 for superiority]). Thromboembolic events occurred in 26 patients (7.0%) in the fibrinogen concentrate group and 35 patients (9.6%) in the cryoprecipitate group. CONCLUSIONS AND RELEVANCEIn patients undergoing cardiac surgery who develop clinically significant bleeding and hypofibrinogenemia after cardiopulmonary bypass, fibrinogen concentrate is noninferior to cryoprecipitate with regard to number of blood components transfused in a 24-hour period post bypass. Use of fibrinogen concentrate may be considered for management of bleeding in patients with acquired hypofibrinogenemia in cardiac surgery.

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Point-of-Care Hemostatic Testing in Cardiac Surgery

Abstract: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02200419.

Cited by 236 publications

References 43 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

Near‐patient coagulation testing to predict bleeding after cardiac surgery: a cohort study

Effect of Fibrinogen Concentrate vs Cryoprecipitate on Blood Component Transfusion After Cardiac Surgery

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