Hemostatic Efficacy of a Flowable Collagen-Thrombin Matrix During Coronary Artery Bypass Grafting: A Double-Blind Randomized Controlled Trial

Abstract

Background Flowable hemostatic agents are advantageous in that they can be applied to irregular wound surfaces and to areas that are difficult to approach directly. We sought to compare the effectiveness and safety of the flowable hemostatic sealants Collastat® (collagen hemostatic matrix, [CHM]) and Floseal® (gelatin hemostatic matrix, [GHM]) during off-pump coronary artery bypass (OPCAB). Methods In this prospective, randomized trial, 160 patients undergoing elective OPCAB surgery were enrolled between March 2018 and February 2020. After primary suture of the aortocoronary anastomosis, an area of hemorrhage was identified, and patients were double blind randomized to receive either CHM or GHM (n = 80, each). Study endpoints were the following: rate of successful intraoperative hemostasis and time required for hemostasis overall postoperative bleeding, rate of transfusion of blood products, rate of surgical revision for bleeding, postoperative morbidity, and intensive care unit stay. Results Of the total patients, 23% were female, and the mean age was 63 years (range: 42–81 years). Successful hemostasis within 5 min was achieved for 78 patients (97.5%) in the GHM group, compared to 80 patients (100%) in the CHM group (p = 0.497). Two patients receiving GHM required surgical revision to achieve hemostasis. There were no differences in the mean time required to obtain hemostasis (GHM vs. CHM, 1.49 ± 0.94 vs. 1.35 ± 0.60 min, p = 0.272), as confirmed by time-to-event analysis (p = 0.605). The two groups had similar amounts of mediastinal drainage for 24 h postoperatively (p = 0.298). The CHM group required less packed red blood cells, fresh frozen plasma, and platelets for transfusion than the GHM group (0.5 vs. 0.7 units per patient, p = 0.047; 17.5% vs. 25.0%, p = 0.034; 7.5% vs. 15.0%, p = 0.032; respectively). Conclusions CHM performed similarly to a commonly used hemostatic agent with regard to achieving effective and fast interoperative hemostasis during OPCAB. The topical flowable hemostatic agent, CHM, could be effectively used during cardiac surgery for intraoperative hemostasis of great vessels with high pressure. Trial registration : ClinicalTrials.gov, NCT 04310150