Ankaferd Blood Stopper Decreases Postoperative Bleeding and Number of Transfusions in Patients Treated with Clopidogrel: A Double-blind, Placebo-controlled, Randomized Clinical Trial

Abstract

Background: The risk of reoperation due to bleeding after open heart surgery is 2.2%-4.2%. Patients who undergo reoperation have a two to six times greater mortality rate. Risk factors for reoperation include: older age, low body mass index, time on extracorporeal circulation, and emergency operations. In coronary artery bypass graft (CABG) patients who are treated preoperatively with antiplatelets, including clopidogrel, the source of postoperative bleeding may be difficult to detect. The aim of this study was to investigate the effectiveness of local Ankaferd blood stopper (ABS) to prevent mediastinal bleeding in CABG patients who were treated with clopidogrel and acetylsalicylic acid (ASA) preoperatively.
Methods: Twenty-five emergency CABG patients premedicated with clopidogrel and ASA as antiplatelet drugs were included in the study (Group 1). An additional twenty-five patients who were premedicated with the same antiplatelet agents were selected as a control group (Group 2). Preoperative clinical characteristics of the two groups were comparable. At the end of the surgery, 4-10 mL of ABS solution was sprayed on the mediastinal and epicardial tissue following protamine administration in Group1. We compared postoperative total mediastinal bleeding, reoperation rate and total blood and blood products transfused between the two groups.
Results: There was no mortality in either of the two groups. Mean postoperative bleeding was 430 mL in the ABS group, and 690 mL in the CG group (P = .044). In the ICU, bleeding in groups 1 and 2 was 610 mL and 980 mL, respectively (P = .025); total bleeding from the mediastinum was 830 mL and 1490 mL, respectively (P = .001) and the amount of autotransfusion was 210 mL and 400 mL (P = .003). Total transfusion of PRBCs in the operating room in groups 1 and 2 was 0.3 and 0.8, respectively (P = .003). No patients in the ABS group needed surgical revision due to severe bleeding or cardiac tamponade.
Conclusion: The use of local ABS reduces bleeding, transfusion requirements of packed red blood cells, platelets and total blood units in patients premedicated with clopidogrel and ASA undergoing emergent CABG .