Cost-utility of point-of-care viscoelastic hemostatic assays in the management of bleeding during cardiac surgery: A single-blinded prospective multicenter stepped wedge cluster randomized trial in French context

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BACKGROUND: The IMOTEC study aims to determine whether a point-of-care viscoelastic hemostatic assay (VHA)-guided algorithm is cost-effective for the management of ongoing bleeding. METHODS: Stepped wedge cluster randomized trial, patient blinded, conducted at 16 French academic cardiac surgery centers from 01/2017 to 02/2020. Adults undergoing elective or urgent cardiac surgery with ongoing bleeding were enrolled during 2 successive inclusion periods: 1) transfusion guided on standard hemostasis tests (control period), and 2) transfusion using a VHA-guided algorithm. The primary objective was to estimate the efficiency of VHA based on the 1-year incremental cost-utility ratio (ICUR, primary outcome). Secondary outcomes included transfusion, postoperative complications, duration of stay in-hospital, reintervention, and mortality. RESULTS: 1095 patients were randomized, and 1044 (95.3%) were analyzed. The mean utility was 0.60 (±0.30) in the VHA vs. 0.61 (±0.30) in the control period, adjusted difference, -0.01 [95% CI, -0.09 to 0.07]. The ICUR did not suggest that the VHA-guided algorithm was cost-effective. One-year mortality was 12.0% for VHA and 10.9% for control, Hazard Ratio, 1.69 [95% CI, 0.98-2.89], P = .06. The frequency of plasma and platelet transfusions was significantly lower in the VHA compared to the control period (respectively, 48.8% vs. 72.4%, P < 0.0001 and 52.3% vs. 74.1%, P = .0002), whereas fibrinogen administration was more frequent in the VHA period (58.4% vs. 47.0%, P = .002). The median in-hospital length of stay was significantly shorter in the VHA vs. control period: 11.0 days (8.0-18.0) vs. 14.0 (9.0-22.0), P = .02. CONCLUSIONS: The ICUR did not suggest that VHA was cost-effective in cardiac surgery patients with ongoing bleeding, compared with standard tests. TRIAL REGISTRATION: Clinical trial submission: November 2, 2016 Registry name: Cost-Utility Analysis of Management of Peri Operative Hemorrhage Following Cardiac Surgery With Cardiopulmonary Bypass (IMOTEC) ClinicalTrials.gov Identifier: NCT02972684 URL registry: https://clinicaltrials.gov/study/NCT02972684.

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