Cost-effectiveness of point-of-care viscoelastic haemostatic assays in the management of bleeding during cardiac surgery: protocol for a prospective multicentre pragmatic study with stepped-wedge cluster randomised controlled design and 1-year follow-up (the IMOTEC study)

Abstract

IntroductionDuring cardiac surgery-associated bleeding, the early detection of coagulopathy is crucial. However, owing to time constraints or lack of suitable laboratory tests, transfusion of haemostatic products is often inappropriately triggered, either too late (exposing to prolonged bleeding and thus to avoidable administration of blood products) or blindly to the coagulation status (exposing to unnecessary haemostatic products administration in patients with no coagulopathy). Undue exposition to transfusion risks and additional healthcare costs may arise. With the perspective of secondary care-related costs, the IMOTEC study (Intérêt MédicO-économique de la Thrombo-Elastographie, dans le management transfusionnel des hémorragies péri-opératoires de chirurgies Cardiaques sous circulation extracorporelle) aims at assessing the cost-effectiveness of a point-of-care viscoelastic haemostatic assay (VHA: RoTem or TEG)-guided management of bleeding. Among several outcome measures, particular emphasis will be put on quality of life with a 1-year follow-up.Methods and analysisThis is a multicentre, prospective, pragmatic study with stepped-wedge cluster randomised controlled design. Over a 36-month period (24 months of enrolment and 12 months of follow-up), 1000 adult patients undergoing cardiac surgery with cardiopulmonary bypass will be included if a periprocedural significant bleeding occurs. The primary outcome is the cost-effectiveness of a VHA-guided algorithm over a 1-year follow-up, including patients’ quality of life. Secondary outcomes are the cost-effectiveness of the VHA-guided algorithm with regard to the rate of surgical reexploration and 1-year mortality, its cost per-patient, its effectiveness with regard to haemorrhagic, infectious, renal, neurological, cardiac, circulatory, thrombotic, embolic complications, transfusion requirements, mechanical ventilation free-days, duration of intensive care unit and in-hospital stay and mortality.Ethics and disseminationThe study was registered at Clinicaltrials.gov and was approved by the Committee for the Protection of Persons of Nantes University Hospital, The French Advisory Board on Medical Research Data Processing and the French Personal Data Protection Authority. A publication of the results in a peer-reviewed journal is planned.Trial registration number NCT02972684; Pre-results.

Gestational hemostasis: a natural model for hemostasis resuscitation of major periprocedural blood loss

“…Evidence-based guidelines (Spahn et al 2019 ; Rossaint et al 2016 ; Kozek-Langenecker et al 2017 ; Lier et al 2016 ), a consensus statement (Munoz et al 2019 ), reviews (Maegele et al 2017 ; Schochl et al 2012 ; Lier et al 2013 ), and original articles (Monaco et al 2020 ; Rigal et al 2019 ; Schaden et al 2012 ; Baksaas-Aasen et al 2017 ) have recently become available regarding the management of massive bleeding following trauma (Spahn et al 2019 ; Maegele et al 2017 ; Rossaint et al 2016 ; Schochl et al 2012 ; Lier et al 2013 ; Baksaas-Aasen et al 2017 ) and cardiac (Monaco et al 2020 ; Rigal et al 2019 ; Scala et al 2020 ), obstetrical (Lier et al 2016 ; Munoz et al 2019 ), and general surgery (Kozek-Langenecker et al 2017 ). These publications integrate POC viscoelastic tests to individualize administration of quantified prothrombotic agents and contain more comprehensive recommendations.…”

“…The importance of hemoglobin and Ca ++ level, core temperature, and pH is underlined in the coagulation process (Spahn et al 2019 ; Maegele et al 2017 ; Rossaint et al 2016 ; Schochl et al 2012 ; Kozek-Langenecker et al 2017 ; Lier et al 2016 ; Munoz et al 2019 ; Lier et al 2013 ; Monaco et al 2020 ; Rigal et al 2019 ; Schaden et al 2012 ).…”

“…Hyperfibrinolysis is a consequence of major tissue trauma. Obtaining direct lysis parameters via rotational thromboelastometry may not be quick enough to assess the severity of fibrinolysis (Maegele et al 2017 ; Lier et al 2013 ; Rigal et al 2019 ; Schaden et al 2012 ; Baksaas-Aasen et al 2017 ). Therefore, early administration of antifibrinolytics is strongly recommended (Spahn et al 2019 ; Maegele et al 2017 ; Rossaint et al 2016 ; Schochl et al 2012 ; Kozek-Langenecker et al 2017 ; Lier et al 2016 ; Munoz et al 2019 ; Lier et al 2013 ; Monaco et al 2020 ; Rigal et al 2019 ; Schaden et al 2012 ; Baksaas-Aasen et al 2017 ; Scala et al 2020 ).…”

“…Administering fibrinogen is an essential component of the goal-directed hemostasis resuscitation strategy (Spahn et al 2019 ; Rossaint et al 2016 ; Kozek-Langenecker et al 2017 ; Munoz et al 2019 ). The comparison of the clot amplitude measured by extrinsically triggered rotational thromboelastometry (EXTEM) and cytochalasin D added EXTEM test (FIBTEM) at 5 (Scala et al 2020 ) or 10 min (Maegele et al 2017 ; Monaco et al 2020 ; Rigal et al 2019 ; Schaden et al 2012 ) or at maximum clot strength (Lier et al 2013 ) can reveal the lack of fibrinogen. Similarly, the difference in maximal clot amplitude measured by rapid thromboelastography (r-TEG) and functional fibrinogen TEG (FF-TEG) can also indicate fibrinogen deficit (Rigal et al 2019 ; Baksaas-Aasen et al 2017 ).…”

“…The comparison of the clot amplitude measured by extrinsically triggered rotational thromboelastometry (EXTEM) and cytochalasin D added EXTEM test (FIBTEM) at 5 (Scala et al 2020 ) or 10 min (Maegele et al 2017 ; Monaco et al 2020 ; Rigal et al 2019 ; Schaden et al 2012 ) or at maximum clot strength (Lier et al 2013 ) can reveal the lack of fibrinogen. Similarly, the difference in maximal clot amplitude measured by rapid thromboelastography (r-TEG) and functional fibrinogen TEG (FF-TEG) can also indicate fibrinogen deficit (Rigal et al 2019 ; Baksaas-Aasen et al 2017 ). Low clot amplitude with FIBTEM at five minutes (Munoz et al 2019 ) may also indicate depleted fibrinogen level.…”