CLINICAL TRIALS
Prospective Randomized Clinical Trial of HEMOPATCH Topical Sealant in Cardiac Surgery
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Luca Weltert, MD, Cardiac Surgeon, Heart Surgery Division, Salvatore D’Aleo, MD, Cardiac Surgeon, Heart Surgery Division, 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
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.
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This study has been completed.
Sponsor: Cardiochirurgia E.H.
Information provided by (Responsible Party): Luca Weltert, Cardiochirurgia E.H.
ClinicalTrials.gov Identifier:
NCT02133378
First received: May 6, 2014
Last updated: January 26, 2016
Last verified: January 2016
A new topical hemostatic agent composed of a specifically-formulated porous collagen matrix, coated on one side with a thin protein bonding layer (known as NHS-PEG) has been reported to be extremely effective, in addition to traditional means, in terminating bleeding during cardiac operations with control rates as high as 97,5%. The investigators compared such hemostatic agent (Hemopatch; Baxter Inc, Deerfield, IL) with traditional optimized hemostasis routine.
Following sample size calculation, in a prospective randomized study design, 100 patients will be treated with Hemopatch and 100 patients will receive traditional optimized hemostasis routine (comparison group).
To make the two cohorts as comparable as possible enrollment will be restricted to moderately bleeding vascular anastomosis of Dacron grafts to ascending aorta or moderately bleeding transversal aortotomy.
Study endpoints are the following: rate of successful intraoperative hemostasis (identified by cessation of bleeding in less than 3 minutes from application) 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.