-
1.
Safety and efficacy of a kaolin-impregnated hemostatic gauze in cardiac surgery: A randomized trial
Mumtaz, M., Thompson, R. B., Moon, M. R., Sultan, I., Reece, T. B., Keeling, W. B., DeLaRosa, J.
JTCVS open. 2023;14:134-144
Abstract
OBJECTIVE A kaolin-based nonresorbable hemostatic gauze, QuikClot Control+, has demonstrated effective hemostasis and safety when used for severe/life-threatening (grade 3/4) internal organ space bleeding. We evaluated the efficacy and safety of this gauze for mild to moderate (grade 1-2) bleeding in cardiac surgery compared with control gauze. METHODS This was a randomized, controlled, single-blinded study of patients who underwent cardiac surgery between June 2020 and September 2021 across 7 sites with 231 subjects randomized 2:1 to QuikClot Control+ or control. The primary efficacy end point was hemostasis rate (ie, subjects achieving grade 0 bleed) through up to 10 minutes of bleeding site application, assessed using a semiquantitative validated bleeding severity scale tool. The secondary efficacy end point was the proportion of subjects achieving hemostasis at 5 and 10 minutes. Adverse events, assessed up to 30 days postsurgery, were compared between arms. RESULTS The predominant procedure was coronary artery bypass grafting, and 69.7% and 29.4% were sternal edge and surgical site (suture line)/other bleeds, respectively. Of the QuikClot Control+ subjects, 121 of 153 (79.1%) achieved hemostasis within 5 minutes, compared with 45 of 78 (58.4%) controls (P < .001). At 10 minutes, 137 of 153 patients (89.8%) achieved hemostasis compared with 52 of 78 controls (68.4%) (P < .001). At 5 and 10 minutes, hemostasis was achieved in 20.7% and 21.4% more QuikClot Control+ subjects, respectively, compared with controls (P < .001). There were no significant differences in safety or adverse events between treatment arms. CONCLUSIONS QuikClot Control+ demonstrated superior performance in achieving hemostasis for mild to moderate cardiac surgery bleeding compared with control gauze. The proportion of subjects achieving hemostasis was more than 20% higher in QuikClot Control+ subjects at both timepoints compared with controls, with no significant difference in safety outcomes.
-
2.
Effect of red blood cell storage time in pediatric cardiac surgery patients: A subgroup analysis of a randomized controlled trial
Martin, S. M., Tucci, M., Spinella, P. C., Ducruet, T., Fergusson, D. A., Freed, D. H., Lacroix, J., Poirier, N., Sivarajan, V. B., Steiner, M. E., et al
JTCVS open. 2023;15:454-467
-
-
-
Free full text
-
Editor's Choice
Abstract
OBJECTIVE This study aimed to determine whether or not transfusion of fresh red blood cells (RBCs) reduced the incidence of new or progressive multiple organ dysfunction syndrome compared with standard-issue RBCs in pediatric patients undergoing cardiac surgery. METHODS Preplanned secondary analysis of the Age of Blood in Children in Pediatric Intensive Care Unit study, an international randomized controlled trial. This study included children enrolled in the Age of Blood in Children in Pediatric Intensive Care Unit trial and admitted to a pediatric intensive care unit after cardiac surgery with cardiopulmonary bypass. Patients were randomized to receive either fresh (stored ≤7 days) or standard-issue RBCs. The primary outcome measure was new or progressive multiple organ dysfunction syndrome, measured up to 28 days postrandomization or at pediatric intensive care unit discharge, or death. RESULTS One hundred seventy-eight patients (median age, 0.6 years; interquartile range, 0.3-2.6 years) were included with 89 patients randomized to the fresh RBCs group (median length of storage, 5 days; interquartile range, 4-6 days) and 89 to the standard-issue RBCs group (median length of storage, 18 days; interquartile range, 13-22 days). There were no statistically significant differences in new or progressive multiple organ dysfunction syndrome between fresh (43 out of 89 [48.3%]) and standard-issue RBCs groups (38 out of 88 [43.2%]), with a relative risk of 1.12 (95% CI, 0.81 to 1.54; P = .49) and an unadjusted absolute risk difference of 5.1% (95% CI, -9.5% to 19.8%; P = .49). CONCLUSIONS In neonates and children undergoing cardiac surgery with cardiopulmonary bypass, the use of fresh RBCs did not reduce the incidence of new or progressive multiple organ dysfunction syndrome compared with the standard-issue RBCs. A larger trial is needed to confirm these results.
PICO Summary
Population
Children admitted to a paediatric intensive care unit after cardiac surgery with cardiopulmonary bypass, enrolled in the Age of Blood in Children in Pediatric Intensive Care Unit trial (ABC-PICU), (n= 178).
Intervention
Fresh (stored ≤7 days) red blood cells (RBCs), (n= 89).
Comparison
Standard-issue RBCs (n= 89).
Outcome
The authors performed a preplanned subgroup analysis of the ABC-PICU trial. The primary outcome measure was new or progressive multiple organ dysfunction syndrome, measured up to 28 days post-randomization or at paediatric intensive care unit discharge, or death. There were no statistically significant differences in new or progressive multiple organ dysfunction syndrome between fresh (43 out of 89 [48.3%]) and standard-issue RBCs groups (38 out of 88 [43.2%]), with a relative risk of 1.12; 95% CI [0.81, 1.54] and an unadjusted absolute risk difference of 5.1%; 95% CI [-9.5%, 19.8%].
-
3.
A comparative study of stored arterial versus venous blood collected using the acute normovolemic hemodilution method in coronary artery bypass grafting patients in Iran
Mansouri, M., Yazdani, A., Masoumi, G., Mirmohammadsadeghi, M., Mirmohammadsadeghi, A.
Acute and critical care. 2023
Abstract
BACKGROUND In the present study, arterial and venous blood was collected from patients who were candidates for elective coronary artery bypass grafting (CABG); the blood was stored for 28 days and cellular, biomechanical, and hematological changes in blood were compared to determine whether stored arterial blood is superior to stored venous blood. METHODS The present follow-up comparative study included 60 patients >18 years of age, with hemoglobin >14 mg/dl and ejection fraction >40% who were candidates for CABG. After induction of anesthesia, 250 ml of arterial or venous blood was drawn from patients (arterial blood group and venous blood group). Laboratory blood samples were taken at specified times from the collected blood and re-injected into the patients after CABG. RESULTS Significant differences were observed in pH, partial pressure of carbon dioxide (PCO2), partial pressure of oxygen (PO2), bicarbonate (HCO3), and glucose values at several time points between the groups. Other parameters such as urea and creatinine did not show any significant differences between the groups. CONCLUSIONS Twenty-eight days of storage can have a negative effect on some of the cellular, biochemical, and hematological components of arterial and venous blood; however, the quality of stored arterial blood and venous blood does not differ significantly.
-
4.
Does bone wax make sense in off-pump coronary surgery? A prospective randomized study
Sorm, Z., Vobornik, M., Dergel, M., Cermakova, E., Harrer, J., Gofus, J.
Kardiochirurgia i torakochirurgia polska = Polish journal of cardio-thoracic surgery. 2023;20(2):67-71
Abstract
INTRODUCTION The effect of bone wax on sternal infection and intraoperative bleeding in off-pump coronary surgery has not been reported in current literature. AIM: To prospectively evalute this in a cohort of high risk patients undergoing off-pump coronary artery surgery at our institution. The potential impact on cell saver utilization was also studied. MATERIAL AND METHODS A prospective randomized study was performed in 58 diabetic patients operated on for two-vessel coronary artery disease by the off-pump technique. They were randomly assigned to the wax or no-wax group. RESULTS There was no significant difference in intraoperative blood loss between the wax (550 ml) and no-wax group (750 ml; p = 0.0711). In multivariate analysis the absence (non-use) of bone wax (odds ratio = 3.9 (1.12-13.51), p = 0.027) and preoperative creatinin level (odds ratio = 1.1 (0.99-1.03), p = 0.03) were identified as independent predictors of blood loss ≥ 750 ml. The number of red blood cell units during hospital stay was similar in both groups (p = 0.42). Wound healing complications were not observed in either group. CONCLUSIONS The use of bone wax does not lead to a higher risk of sternal wound infection. It may reduce the risk of high intraoperative blood loss, thus avoiding the need of a cell saver during off-pump coronary surgery. However, this influence remains questionable.
-
5.
Low-Dose vasopressin and renal perfusion in pediatric cardiac surgery
Kumar, A., Ghotra, G. S., Raj, S., Tiwari, N., Ramamurthy, H. R.
Annals of cardiac anaesthesia. 2023;26(3):309-317
Abstract
BACKGROUND Congenital heart surgeries are associated with post-bypass renal and cardiac dysfunctions. The use of low-dose vasopressin has been found to be beneficial in adult cardiac surgeries. OBJECTIVE To assess the hemodynamic and renal effects of patients undergoing on-pump pediatric cardiac surgery under general anesthesia (GA) with low-dose vasopressin infusion. DESIGN Prospective randomized controlled study. SETTING Operation room and ICU, tertiary care teaching hospital. PATIENTS Fifty-five pediatric cardiac patients undergoing repair for congenital heart diseases (CHD). INTERVENTIONS Low-dose vasopressin infusion in the study group and placebo in the control group. MEASUREMENTS AND MAIN RESULTS Renal near-infrared spectroscopy (NIRS), serum NGAL, and inflammatory mediators-IL6 and IL8 along with other renal and hemodynamic parameters in the perioperative period were recorded. Diastolic blood pressure (DBP) and cardiac index were significantly higher in the vasopressin group. Inflammatory markers were significantly high in the immediate postoperative period in all patients which later stabilized in the next 48 h but showed similar trends in both groups. Low-dose vasopressin infusion did not improve either renal perfusion or function. The duration of mechanical ventilation and length of hospital stay, the incidence of AKI development, and transfusion requirements were marginally lower in the vasopressin group, although not significant. CONCLUSION Low-dose vasopressin infusion improved hemodynamics and showed a decreased incidence of complications. However, it failed to show any benefit of renal function and overall outcome in pediatric cardiac surgery.
-
6.
Platelet Function Testing Using Sonoclot and TEG6s as a Platelet Transfusion Prediction Tool in Open Heart Surgery
Sato, T., Edanaga, M., Yamakage, M., Harada, R., Kawaharada, N.
Cureus. 2023;15(11):e49131
Abstract
Introduction The point-of-care test (POCT) is useful for blood coagulation management during cardiovascular surgery. Although thromboelastography (TEG6s) has been reported to have targeted benefits for blood transfusion in cardiac surgery, Sonoclot analysis has not yet been fully validated. In this study, we evaluated the accuracy of Sonoclot, especially platelet function (PF) as a platelet concentrate (PC) transfusion parameter, compared to TEG6s in cardiovascular surgery. Methods This single-center, prospective, randomised trial was conducted at a university hospital. Forty-two adult patients who underwent elective cardiac surgery requiring cardiopulmonary bypass were included in this study between 2017 and 2021. The participants were randomly assigned to the Sonoclot (S) or Sonoclot and TEG6s (ST) groups. The amount of intraoperative PC was determined according to the POCT parameter values at the time of protamine administration. In addition, we investigated the correlation between PF parameters of POCT and platelet count at the end of surgery. Results There was no statistically significant difference in the intraoperative PC volume between the two groups. The Sonoclot PF parameter, PF, was moderately correlated with platelet count at the end of surgery (r=0.5449, p=0.009), and the TEG6s PF parameter showed a strong correlation with platelet count at the end of surgery (r=0.7744, p<0.001). Conclusion There was no statistically significant difference in platelet transfusion volume between the Sonoclot and TEG6s in this study. The correlation between the PF of the Sonoclot and platelet count was moderate. This study suggests that PF of Sonoclot may be a potentiating indicator of PF.
-
7.
Effect of Preoperative Administration of Intravenous Ferric Carboxymaltose in Patients with Iron Deficiency Anemia after Off-Pump Coronary Artery Bypass Grafting: A Randomized Controlled Trial
Kim HH, Park EH, Lee SH, Yoo KJ, Youn YN
Journal of clinical medicine. 2023;12(5)
Abstract
Patients scheduled for cardiac surgery often have anemia and iron deficiency. We investigated the effect of the preoperative administration of intravenous ferric carboxymaltose (IVFC) in patients with iron deficiency anemia (IDA) who were due to undergo off-pump coronary artery bypass grafting (OPCAB). Patients who were due to undergo elective OPCAB between February 2019 and March 2022 who had IDA (n = 86) were included in this single center, randomized, parallel-group controlled study. The participants were randomly assigned (1:1) to receive either IVFC or placebo treatment. Postoperative hematologic parameters [hemoglobin (Hb), hematocrit, serum iron concentration, total iron-binding capacity, transferrin saturation, transferrin concentration, and ferritin concentration] and the changes in these parameters during the follow-up period were the primary and secondary outcomes, respectively. The tertiary endpoints were early clinical outcomes, such as the volume of mediastinal drainage and the need for blood transfusions. IVFC treatment significantly reduced the need for red blood cell (RBC) and platelet transfusions. Despite receiving fewer RBC transfusions, patients in the treatment group had higher levels of Hb, hematocrit, and serum iron and ferritin concentrations during weeks 1 and 12 after surgery. No serious adverse events occurred during the study period. Preoperative IVFC treatment in patients with IDA undergoing OPCAB improved the values of the hematologic parameters and iron bioavailability. Therefore, is a useful strategy for stabilizing patients prior to OPCAB.
-
8.
Fibrin Sealant TISSEEL Lyo as a haemostatic agent in vascular surgery: Results of randomized, controlled, patient-blinded, multicentre clinical study in the Russian population
Karpenko, A. A., Cheban, A. V., Rabtsun, A. A., Sokurenko, G. Y., Andreychuk, K. A., Kim, I. N., Volf, V. A., Kuznetsov, M. R., Prostov,, II, Sapronova, N. G., et al
Science progress. 2023;106(3):368504231182834
Abstract
BACKGROUND This phase III, controlled, patient-blinded, multicentre study in two parallel, equal-sized treatment groups compared the efficacy and safety of TISSEEL Lyo, fibrin sealant versus Manual Compression (MC) with surgical gauze pads for use as a haemostatic agent in patients who underwent vascular surgery in Russia. METHODS Adult patients, both genders, who received peripheral vascular expanded polytetrafluoroethylene conduits and had suture line bleeding after surgical haemostasis were enrolled. Patients were randomized to be treated with TISSEEL Lyo or MC. The bleeding needed additional treatment and had to be assessed as grade 1 or 2 bleeding according to the Validated Intraoperative Bleeding scale. The primary efficacy endpoint was the proportion of patients achieving haemostasis at 4 min after treatment application (T(4)) at the study suture line, which was maintained until the closure of the surgical wound. The secondary efficacy endpoints included the proportion of patients achieving haemostasis at 6 min (T(6)) and 10 min (T(10)) after treatment application at the study suture line, which was maintained until closure of the surgical wound, as well as the proportion of patients with intraoperative and postoperative rebleeding. Safety outcomes included incidence of adverse events (AEs), surgical site infections and graft occlusions. RESULTS A total of 110 patients were screened; 104 patients were randomized: (TISSEEL Lyo: 51 [49%] patients; MC: 53 [51%] patients). T(4) haemostasis was achieved in 43 (84.3%) patients in the TISSEEL Lyo group and in 11 (20.8%) patients in the MC group (p < 0.001). Significantly more patients in TISSEEL Lyo group achieved the haemostasis at T(6) (relative risk (RR) of achieving haemostasis 1.74 [95% confidence interval (CI) 1.37; 2.35]) and T(10) (RR 1.18 [95% CI 1.05; 1.38]) versus MC. No one had intraoperative rebleeding. Postoperative rebleeding was reported only in one patient in the MC group. No treatment-emergent serious AEs (TESAEs) related to TISSEEL Lyo/MC, TESAEs leading to withdrawal and TESAEs leading to death were reported in patients during the study. CONCLUSIONS Data demonstrated TISSEEL Lyo had clinically and statistically significant superiority to MC as a haemostatic agent in vascular surgery at all measured time points including 4, 6 and 10 min and had proven to be safe.
-
9.
The impact of using fresh frozen plasma in cardiopulmonary bypass preparation on thromboelastometric parameters and receiving blood products among pediatric patients undergoing cardiac surgery
Abedzadeh, M., Kachoueian, N., Fazli, A., Pazhoha, M., Orouji Omid, S., Vahid, P., Givtaj, N.
Journal of cardiovascular and thoracic research. 2023;15(1):9-13
Abstract
Introduction: The aim of this study was to determine the effect of fresh frozen plasma (FFP) for priming of cardiopulmonary bypass (CPB) circuit on rotational thromboelastometry (ROTEM) and transfusion in pediatric cardiac surgery. Methods: Eighty patients younger than seven years old, were divided into case (FFP) (n=40) and control (n=40) groups. In the case group,10-20 mL/kg fresh frozen plasm was used for priming the CPB. The control group received 10-20 mL/kg of hydroxyethyl starch. ROTEM was done before surgical incision and after separation from CPB. The amount of transfusion (platelet and FFP) in the operating room and 24 hours after surgery were recorded. Results: Statistically significant difference was found between the case and control group in terms of changes in the Rotem parameters. The amount of transfusion of platelets in the operating room was significantly higher in the control group than in the case group. Conclusion: It seems that adding FFP to the prime solution is more effective in young patients and infants due to the higher susceptibility of the infant coagulation system to coagulation and hemorrhagic disorders in comparison with other patients.
-
10.
Refraining from Packed Red Blood Cells in Cardiopulmonary Bypass Priming as a Method of Neuroprotection in Pediatric Cardiac Surgery
Ivkin AA, Grigoriev E, Sinitskaya AV
Journal of clinical medicine. 2023;12(4)
Abstract
Congenital heart defect (CHD) surgeries are performed with cardiopulmonary bypass (CPB) and are complicated by several factors that affect the child's brain. However, to date, the number of studies on brain protection in cardiac surgery remains small. The aim of this study was to assess the impact of refraining from using packed red blood cells (PRBCs) in priming solutions in children with congenital defects (CHDs) who require surgical interventions using CPB to prevent brain injury in the postoperative period. MATERIAL AND METHODS This study included 40 children, and the mean age was 14 (12-22.5) months and the mean weight was 8.8 (7.25-11) kg. All patients underwent CHD closure using CPB. The patients were divided into two groups depending on the use of PRBCs in the priming solution. Brain injury was assessed using three specific blood serum markers, namely S100 calcium-binding protein β (S100β), neuron-specific enolase (NSE) and glial fibrillary acidic protein (GFAP) before surgery, after the completion of CPB and 16 h after surgery (first, second and third control points). Markers of systemic inflammatory response were also analyzed, including interleukin-1, -6, -10 and tumor necrosis factor alpha (TNF-α). A clinical assessment of brain injury was carried out using a valid, rapid, observational tool for screening delirium in children of this age group, i.e., "Cornell Assessment of Pediatric Delirium". RESULTS Factors of the intra- and postoperative period were analyzed, such as hemoglobin levels, oxygen delivery (cerebral tissue oxygenation, blood lactate level and venous oxygen saturation) and indicators of organ dysfunction (creatinine, urea, bilirubin levels, duration of CPB and length of stay in the ICU). Following the procedure, there were no significant differences between the groups and all indicators were within the reference values, thus demonstrating the safety of CHD closure without transfusion. Moreover, the highest level of specific markers of brain injury were noted immediately after the completion of CPB in both groups. The concentration of all three markers was significantly higher in the group with transfusion after the completion of CPB. Moreover, GFAP levels were higher in the transfusion group and 16 h after surgery. CONCLUSIONS The results of the study show the safety and effectiveness of brain injury prevention strategies that consist of not conducting PRBC transfusion.