Prospective Randomized Clinical Trial of HEMOPATCH Topical Sealant in Cardiac Surgery

Abstract:

Objective: Hemostasis is a critical component of all surgical procedures and especially cardiac surgery. In addition to traditional means, topical hemostatic agents have been reported to be extremely effective in terminating bleeding during cardiac procedures. We compared a hemostatic matrix sealant agent (HEMOPATCH Baxter Healthcare Corporation, Deerfield, IL) with alternative topical hemostatic treatment in patients undergoing ascending aorta surgery with moderate bleeding. Materials and Methods: Following sample size calculation, in a prospective randomized study design, 85 patients were treated with HEMOPATCH matrix sealant and 85 patients received alternative treatment (dry or wet gauze compression or similar [control group]). The primary outcome measure was the percentage of patients with successful hemostasis within three minutes of HEMOPATCH or traditional treatment application. Other study outcome measures were postoperative blood loss and the rate of transfusion of blood products. Results: A statistically higher rate of successful hemostasis within three minutes was observed in the HEMOPATCH group (97.6% [83/85] vs. 65.8% [56/85] in the control group; p<0.001). The percentages of patients with postoperative bleeding and the rate of transfusion were lower in the HEMOPATCH group than in the control group. Conclusions: The use of HEMOPATCH is effective in terminating bleeding in patients undergoing ascending aorta cardiac procedures. Fewer patients treated with HEMOPATCH required blood transfusion. The cost-utility profile of HEMOPATCH should be addressed in dedicated trials.

Authors:

Luca Weltert, MD, Cardiac Surgeon, Heart Surgery Division, Salvatore D'Aleo, MD, Cardiac Surgeon, Heart Surgery Division, European Hospital, Rome, Italy, Ilaria Chirichilli, MD, Cardiac Surgeon, Heart Surgery Division, Mauro Falco, MD, Anaesthesiologist, Anesthesiology Division, Franco Turani, MD, Anaesthesiologist, Anesthesiology Division, Alessandro Bellisario, MD, Cardiac Surgeon, Heart Surgery Division, Ruggero De Paulis, MD, Cardiac Surgeon, Heart Surgery Division, European Hospital, Rome, Italy

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