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

2015 ◽  
Vol 18 (3) ◽  
pp. 118 ◽  
Author(s):  
Mehmet Besir Akpinar ◽  
Atakan Atalay ◽  
Hakan Atalay ◽  
Omer Faruk Dogan

<strong>Background</strong>: 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.<br /><strong>Methods</strong>: 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.<br /><strong>Results</strong>: 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. <br /><strong>Conclusion</strong>: 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 .

2002 ◽  
Vol 97 (2) ◽  
pp. 367-373 ◽  
Author(s):  
Valter Casati ◽  
Giovanni Speziali ◽  
Cesare D'Alessandro ◽  
Clara Cianchi ◽  
Maria Antonietta Grasso ◽  
...  

Background Recently, various studies have questioned the efficacy of intraoperative acute normovolemic hemodilution (ANH) in reducing bleeding and the need for allogeneic transfusions in cardiac surgery. The aim of the present study was to reevaluate the effects of a low-volume ANH in elective, adult open-heart surgery. Methods Two hundred four consecutive adult patients undergoing cardiac surgery were prospectively randomized in a nonblinded manner into two groups: ANH group (103 patients), where 5-8 ml/kg of blood was withdrawn before systemic heparinization and replaced with colloid solutions, and a control group, where no hemodilution was performed (101 patients). Procedures included single and multiple valve surgery, aortic root surgery, coronary surgery combined with valve surgery, or partial left ventriculectomy. The purpose of the study was to evaluate the efficacy of ANH in reducing the need for allogeneic blood components. Routine hematochemical evaluations, perioperative blood loss, major complications, and outcomes were also recorded. Results No differences were found between the groups regarding demographics, baseline hematochemical data, and operative characteristics. There was no difference in the amount of transfusions of packed red cells, fresh frozen plasma, platelet concentrates, total number of patients transfused (control group, 36% vs. ANH group, 34.3%; P = 0.88), and amount of postoperative bleeding (control group, 412 ml [313-552 ml] vs. ANH group, 374 ml [255-704 ml]) (median [25th-75th percentiles]); P = 0.94. Further, perioperative complications, postoperative hematochemical data, and outcomes were not different. Conclusions In patients undergoing elective open-heart surgery, low-volume ANH showed lack of efficacy in reducing the need for allogeneic transfusions and postoperative bleeding.


Circulation ◽  
2001 ◽  
Vol 104 (suppl_1) ◽  
Author(s):  
Giovanni Battista Luciani ◽  
Tiziano Menon ◽  
Barbara Vecchi ◽  
Stefano Auriemma ◽  
Alessandro Mazzucco

Background Extracorporeal circulation contributes to morbidity after open-heart surgery by causing a systemic inflammatory reaction. Modified ultrafiltration is a technique able to remove the fluid overload and inflammatory mediators associated with use of cardiopulmonary bypass. It has been shown to reduce morbidity after cardiac operations in children, but the impact on adult cardiac procedures is unknown. Methods and Results Five hundred seventy-three consecutive adult patients were prospectively randomized to either ultrafiltration after cardiopulmonary bypass (treatment) or to no ultrafiltration (control). Parsonnet score was used to assess the severity of the patients’ clinical conditions. Analysis was done with Student’s t test or Mann-Whitney U test for continuous variables and Fisher’s exact test or Pearson’s χ 2 for discrete variables. Hospital mortality was 2.5% (7 of 284) in the treatment group versus 3.8% (11 of 289) in the control group ( P =0.357). Hospital morbidity was lower in treated patients (66 of 284 [23.2%] versus 117 of 289 [40.5%], P =0.0001). Cardiac morbidity was similar (26 of 284 [9.1%] versus 35 of 289 [12.1%], P =0.251), whereas significantly lower rates of respiratory (20 of 284 [7.0%] versus 36 of 289 [12.5%], P =0.029), neurological (5 of 284 [1.8%] versus 14 of 289 [4.8%], P =0.039), and gastrointestinal (0 of 284 versus 4 of 289 [1.4%], P =0.044) complications were found in treated patients. Transfusion requirements were also lower in treated patients (1.66±2.6 versus 2.25±3.8 U/patient, P =0.039). Duration of intensive care (39.9±49.2 versus 46.3±72.8 hours, P =0.218) and hospital stay (7.6±3.5 versus 7.9±4.4 days, P =0.372) were comparable. Conclusions Modified ultrafiltration after cardiopulmonary bypass is associated with a lower prevalence of early morbidity and lower blood transfusion requirements. The impact on length of hospital stay needs further analysis. Routine application of modified ultrafiltration after adult cardiac operations is warranted.


2018 ◽  
Vol 28 (11) ◽  
pp. 1289-1294 ◽  
Author(s):  
Ikechukwu A. Nwafor ◽  
Onyinyechukwu A. Arua ◽  
John C. Eze ◽  
Ndubueze Ezemba ◽  
Maureen N. Nwafor

AbstractBackgroundIn Nigeria, access to open heart surgery (OHS) is adversely affected by insufficient blood and blood products, including the challenges because of the lack of patient-focused blood management strategies owing to the absent requisite point-of-care tests in the operating theatre (OR)/ICU. In addition, the limited availability of altruistic blood donors including the detection of transfusion transmitted infections more commonly among non-altruistic blood donors is another burden affecting the management of excessive bleeding during and after open heart surgery in our country.ObjectiveThe objective of this study was to review our local experience in the use of blood and blood products during open heart surgery and compare the same with the literature.Materials and methodsIn a period of 3 years (March, 2013–February, 2016), we performed a retrospective review of those who had open heart surgery in our institution. The data were obtained from our hospital health information technology department. The data comprised demography, types of operative procedures and units of blood and blood products transfused per procedure, including the details regarding the usage of the cell saver, as well as those who had severe bleeding requiring excessive blood transfusion.ResultsDuring the study period, 102 patients had open heart surgery, an average of 34 cases in a year. Among them, there were 75 (73.53%) males and 37 (36.27%) females, giving a ratio of 2:1. The ages of the patients were from 0.6 (7/12) to 74 years. Mitral valve procedure was the most common (n=22, 21.6%) surgery type. Transfusion requirements averaged 1.9 units of fresh frozen plasma, 0.36 units of platelet concentrate, and 1.68 units of packed cells per procedure. The least common surgical procedure was common atrium repair (n=1, 0.01%).ConclusionOpen heart procedure is a very complex procedure requiring cardiopulmonary bypass with associated severe perioperative bleeding. The attendant blood loss and haemostatic challenges are combated by intricate and selective transfusions of allogeneic blood and or blood products.


2009 ◽  
Vol 2009 ◽  
pp. 1-6 ◽  
Author(s):  
Ahmed Shalaby ◽  
Timo Rinne ◽  
Otso Järvinen ◽  
Juha Latva-Hirvelä ◽  
Kristiina Nuutila ◽  
...  

Background. We studied the effect of fast induction of cardiac arrest with denosine on myocardial bax and bcl-2 expression.Methods and Results. 40 elective CABG patients were allocated into two groups. The adenosine group (n=20) received 250 μg/kg adenosine into the aortic root followed by blood potassium cardioplegia. The control group received potassium cardioplegia in blood. Bcl-2 and bax were measured. Bax was reduced in the postoperative biopsies (1.38 versus 0.47,P=.002) in the control group. Bcl-2 showed a reducing tendency (0.14 versus 0.085,P=.07). After the adenosine treatment, the expression of both bax (0.52 versus 0.59,P=.4) and bcl-2 (0.104 versus 0.107,P=.4) remained unaltered after the operation.Conclusion. Open heart surgery is associated with rapid reduction in the expression of apoptosis regulating genes bax and bcl-2. Fast Adenosine induction abolished changes in their expression.


2017 ◽  
Vol 9 ◽  
pp. 117906521772090 ◽  
Author(s):  
Noppon Taksaudom ◽  
Metus Ketwong ◽  
Nirush Lertprasertsuke ◽  
Aphisek Kongkaew

Objective: The operating procedure of a resternotomy in open-heart surgery is a complicated procedure with potentially problematic outcomes partly due to potential adhesions in the pericardial cavity and retrosternal space. Use of a collagen membrane has shown encouraging results in adhesion prevention in several regions of the body. This study was designed to evaluate the effectiveness of the use of this collagen membrane in the prevention of pericardial adhesions. Materials and methods: A total of 12 pigs were divided randomly into 2 groups: an experimental group in which collagen membranes were used and a control group. After sternotomy and an anterior pericardiectomy, the epicardial surface was exposed to room air and irrigated with saline, and an epicardial abrasion was performed using a sponge. The pericardial defect was repaired using a collagen membrane in the experimental group or left uncovered in the control group. After 8 to 12 weeks, the pigs were killed, and a resternotomy was performed by a single-blinded surgeon enabling the evaluation of adhesions. The heart was then removed and sent for microscopic assessment conducted by a single-blinded pathologist. Results: The resternotomy operations performed using a collagen membrane demonstrated a nonstatistically significant trend of fewer macroscopic and microscopic adhesions in all regions ( P > .05), particularly in the retrosternal and defect regions. Conclusions: This study showed nonstatistically significant differences between the outcomes in the collagen membrane group and the control group in both macroscopic and microscopic adhesion prevention. Due to the many limitations in animal study design, further studies in human models will be needed before the true value of this procedure can be evaluated.


Author(s):  
Murat Aksun ◽  
Saliha Aksun ◽  
Mehmet Ali Çoşar ◽  
Elif Neziroğlu ◽  
Senem Girgin ◽  
...  

Objective: Thromboelastography (TEG) is a diagnostic modality that gives information about coagulation. Despite all blood-preserving precautions in open heart surgery there are blood losses and the use of blood and blood products becomes inevitable. TEG is mostly not available in every center and habits, trends and clinical experience in blood use create the possibility of causing unnecessary use of blood and blood products. In this study, it was aimed to determine the effect of the use of thromboelastography on the use of blood and blood products in cardiac surgery. Methods: Two hundred patients between 18-70 years old who underwent open heart surgery were included in the study. After the cardiopulmonary bypass (CPB), the cases were confirmed to have an Activated Clotting Time (ACT) value in the range of 120-150 sec after protamine administration. In 100 patients in the TEG group, the coagulation status was evaluated with TEG and it was decided how to apply blood and blood product use. Blood and blood product use was applied to 100 patients in the control group based on clinical experience and foresight. The total amount of blood and blood product used, fluid balance, need for inotropics, mechanical ventilator time, complications, duration of intensive care and discharge times were recorded. Results: Use of Fresh Frozen Plasma (FFP) at the after CPB in the TEG group was statistically significantly lower than that of the control group FFP (p<0.05). Postoperative FFP and postoperative platelet use in the study group were statistically significantly lower than in the postoperative FFP and postoperative platelet values of the control group (p <0.05). Conclusion: The use of thromboelastography is a very useful monitoring in terms of reducing FFP use after CPB and reducing FFP and platelet usage in the postoperative period. In this way, the unnecessary use of blood and blood products can be prevented.


2021 ◽  
Vol 39 ◽  
Author(s):  
Luca Pierelli ◽  
◽  
Alessandro De Rosa ◽  
Mauro Falco ◽  
Elsie Papi ◽  
...  

Background: Low preoperative haemoglobin is frequently observed in heart surgery patients and is associated with a significant decrease in haemoglobin between post-operative days 2 and 3, known as haemoglobin drift. Overall, these patients tend to receive many RBC transfusions. Since iron homeostasis is often impaired in these patients, restoration of iron availability might override iron-restricted erythropoiesis. However, reduced tolerance to oral iron salts has limited this strategy to intravenous iron administration. Study Design and Methods: The purpose of this study was to assess whether preoperative supplementation with oral sucrosomial iron, a new iron-delivery technology with improved tolerance and bioavailability, might be an effective strategy for this patient population. One thousand consecutive patients were randomized and received either a one-month course of sucrosomial iron (60 mg/day) or no treatment prior to elective heart surgery at a single high-volume centre (ClinicalTrials.gov NCT03560687). Primary end-points were haemoglobin concentration on the day of hospital admittance and number of blood transfusions. Secondary end-points were haemoglobin drift, tolerance of treatment and cost-effectiveness of sucrosomial iron administration. Results: Baseline haemoglobin in the treatment group was higher (by 0.67 g/dL; p<0.001) than that in the control group. The percentage of patients in the treatment group who required transfusion (35.4%) was half that in the control group (64.6%). The average number of transfused units per operation was 0.95 vs. 2.03 in the treatment and control groups, respectively. Haemoglobin drift was substantially similar in the two groups, and the tolerability of treatment was excellent (98%). The overall cost of treatment was 156 Euros less in the treatment group, expressed as a raw cost of transfusion. Conclusion: In elective heart surgery, routine preoperative sucrosomial iron administration seems to be a safe, well-tolerated and cost-effective strategy to increase preoperative haemoglobin and reduce the need for allogeneic blood transfusions.


Author(s):  
Elizabeth B Pathak ◽  
Amit P Pathak

Objectives: Major therapeutic cardiac procedures include open heart surgery (e.g., coronary artery bypass graft, valv/septum repairs) (OPEN), insertion/repair of pacemakers, internal defibrillators, and related devices (PACE), and percutaneous coronary intervention (PCI). The use of these procedures among patients aged > 85 years has not been well-described. Methods: Inpatient records for adults aged > 85 years were obtained from a comprehensive all-payer hospital discharge database for Florida for 2006-2011. Major cardiac procedures were identified by ICD-9-CM codes. Patient race/ethnicity (non-Hispanic White, Hispanic, non-Hispanic Black), gender, payer, principal/secondary diagnoses, and in-hospital mortality were analyzed for each procedure type. Annual procedure rates were calculated using US Census population estimates. Results: There were 2,497,573 person-years at risk for the period 2006-2011, with a total of 1,355,308 inpatient hospitalizations in this very elderly population. Medicare coverage ranged from 88% in Hispanic men (HM) to 96% in White women (WW). Procedure rates were higher in Medicare patients vs. all other payers. PACE was the most common major cardiac procedure (n=32,338), followed by PCI (n=17,046) and OPEN (n=5,916). Population rates of each procedure varied significantly by race/ethnicity and gender (see Figure for PACE rates). In 2011, the rate of PCI for White men (WM) (89 per 10,000, 95% CI 84 to 94) was 20% higher compared to HM, 70% higher compared to Black men (BM), 80% higher than WW and Black women (BW), and 130% higher than Hispanic women (HW). The open heart surgery rate for WM (41 per 10,000, 95% CI 38 to 45) was significantly higher than all other groups: 1.6 times the rate for HM, 2.9 times the rate for WW, 4.1 times the rate for HW, 8.2 times the rate for BM and 10.3 times the rate for BW. In-hospital mortality rates were 1.4% for PACE, 4.3% for PCI, and 8.2% for OPEN. Temporal trends showed declining rates for all procedures over the study period. Conclusions: Major therapeutic cardiac interventions are common among the very elderly. Greater inclusion of very elderly patients in clinical trials and outcome studies is necessary to establish the survival and quality of life benefits of these procedures for patients near the end of life.


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