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Randomized Pilot Trial of Acute Normovolemic Hemodilution in Pediatric Cardiac Surgery Patients
Harris WM, Treggiari MM, LeBlanc A, Giacomuzzi C, You JJ, Muralidaran A, Shen I
World J Pediatr Congenit Heart Surg. 2020;11(4):452-458
Abstract
BACKGROUND Due to the substantial improvement in survival among pediatric patients undergoing congenital heart surgery, reducing early and long-term morbidity is becoming the major focus of care. Blood transfusion is associated with worse postoperative outcomes after cardiac surgery. Acute normovolemic hemodilution (ANH) is a blood conservation strategy that aims to reduce allogenic blood transfusion during cardiac surgery. However, there are scant data regarding its efficacy for pediatric cardiac surgery patients. METHODS We designed a single-center, controlled, randomized, pilot trial in patients between 6 and 36 months old undergoing pediatric heart surgery. Patients were equally assigned to undergo ANH prior to initiation of cardiopulmonary bypass or to be managed per usual care. The primary end point was the amount of blood product transfused perioperatively. Secondary end points were markers of morbidity: postoperative bleeding, hematocrit, inotropic agents use, intensive care unit, and hospital stay. The analysis was by intention-to-treat. Estimates of differences between groups are presented with 95% CIs. RESULTS Twelve pediatric heart surgery patients were randomized to each group, ANH and usual care. Baseline characteristics were similar between groups. Acute normovolemic hemodilution implementation did not result in a reduction in the administration of blood product transfused (difference between ANH and usual care among patients transfused = -1.4 mL [-29.4 to 26.6], P = .92). Secondary end points were not different between groups. CONCLUSIONS In this small trial of pediatric cardiac surgery patients, ANH as a strategy to reduce blood component therapy was safe; however, the study failed to show a reduction in perioperative transfusion or other postoperative outcomes.
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Superior blood-saving effect and postoperative recovery of comprehensive blood-saving strategy in infants undergoing open heart surgery under cardiopulmonary bypass
Wu T, Liu J, Wang Q, Li P, Shi G
Medicine. 2018;97((27)):e11248.
Abstract
BACKGROUND Optimization of blood-saving strategies during open heart surgery in infants is still required. This study aimed to study a comprehensive blood-saving strategy during cardiopulmonary bypass (CPB) on postoperative recovery in low-weight infants undergoing open heart surgery. METHODS This was a prospective study of 86 consecutive infants (weighing <5 kg) with acyanotic congenital heart disease treated at the Tianjin Chest Hospital between March and December 2016, and randomized to the control (traditional routine CPB) and comprehensive blood-saving strategy groups. The primary endpoints were blood saving and clinical prognosis. The secondary endpoints were safety and laboratory indicators, prior to CPB (T1), after 30 minutes of CPB (T2), after modified ultrafiltration (T3), and postoperative 12 (T4), 24 (T5), 48 (T6), and 72 h (T7). RESULTS The total priming volume and banked red blood cells in the comprehensive strategy group were significantly lower than in the control group (P = .009 and P = .04, respectively). In the comprehensive strategy group, immediately after CPB, the amount of salvaged red blood cells exceeded the priming red blood cells by 40 +/- 11 mL. Postoperatively, the comprehensive strategy group showed a significant decrease in the inotrope score (P = .03), ventilation time (P = .03), intensive care unit stay (P = .04), and hospital stay (P = .03) in comparison with the control group. CONCLUSION The comprehensive blood-saving strategies for CPB were associated with less blood use and favorable postoperative recovery in low-weight infants with congenital heart disease undergoing open heart surgery.
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Transfusion of cell saver salvaged blood in neonates and infants undergoing open heart surgery significantly reduces RBC and coagulant product transfusions and donor exposures: results of a prospective, randomized, clinical trial
Cholette JM, Powers KS, Alfieris GM, Angona R, Henrichs KF, Masel D, Swartz MF, Daugherty LE, Belmont K, Blumberg N
Pediatric Critical Care Medicine. 2013;14((2):):137-47.
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Abstract
OBJECTIVE To evaluate whether transfusion of cell saver salvaged, stored at the bedside for up to 24 hrs, would decrease the number of postoperative allogeneic RBC transfusions and donor exposures, and possibly improve clinical outcomes. DESIGN Prospective, randomized, controlled, clinical trial. SETTING Pediatric cardiac intensive care unit. PATIENTS Infants weighing less than 20 kg (n = 106) presenting for cardiac surgery with cardiopulmonary bypass. INTERVENTIONS Subjects were randomized to a cell saver transfusion group where cell saver blood was available for transfusion up to 24 hrs after collection, or to a control group. Cell saver subjects received cell saver blood for volume replacement and/or RBC transfusions. Control subjects received crystalloid or albumin for volume replacement and RBCs for anemia. Blood product transfusions, donor exposures, and clinical outcomes were compared between groups. MEASUREMENTS AND MAIN RESULTS Children randomized to the cell saver group had significantly fewer RBC transfusions (cell saver: 0.19 +/- 0.44 vs. control: 0.75 +/- 1.2; p = 0.003) and coagulant product transfusions in the first 48 hrs post-op (cell saver: 0.09 +/- 0.45 vs. control: 0.62 +/- 1.4; p = 0.013), and significantly fewer donor exposures (cell saver: 0.60 +/- 1.4 vs. control: 2.3 +/- 4.8; p = 0.019). This difference persisted over the first week post-op, but did not reach statistical significance (cell saver: 0.64 +/- 1.24 vs. control: 1.1 +/- 1.4; p = 0.07). There were no significant clinical outcome differences. CONCLUSION Cell saver blood can be safely stored at the bedside for immediate transfusion for 24 hrs after collection. Administration of cell saver blood significantly reduces the number of RBC and coagulant product transfusions and donor exposures in the immediate postoperative period. Reduction of blood product transfusions has the potential to reduce transfusion-associated complications and decrease postoperative morbidity. Larger studies are needed to determine whether this transfusion strategy will improve clinical outcomes.
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Transfusion of salvaged blood in pediatric heart surgery reduces allogeneic transfusions: a prospective, randomized trial
Cholette JM, Powers KS, Alfieris GM, Angona R, Henrichs KF, Masel DS, Swartz M, Daugherty LE, Belmont K, Blumberg N
Transfusion. 2012;52((S3):):121A.. Abstract No. SP176.
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A trial of fresh autologous whole blood to treat dilutional coagulopathy following cardiopulmonary bypass in infants
Friesen RH, Perryman KM, Weigers KR, Mitchell MB, Friesen RM
Paediatric Anaesthesia. 2006;16((4):):429-35.
Abstract
BACKGROUND Transfusion of fresh whole blood is superior to blood component therapy in correcting coagulopathies in children following cardiopulmonary bypass (CPB); however, a supply of fresh homologous whole blood is difficult to maintain. We hypothesized that transfusion of fresh autologous whole blood obtained prior to heparinization for CPB and infused following CPB would be associated with improved coagulation function when compared with standard therapy. METHODS A total of 32 infants 5-12 kg undergoing noncomplex open cardiac surgery were randomly assigned to either the treatment or control group. In the treatment group, 15 ml x kg(-1) of autologous whole blood was collected into a CPDA bag prior to heparinization while 15 ml x kg(-1) of 5% albumin was infused intravenously. After reversal of heparin, coagulation tests were drawn in both groups, and the autologous whole blood was infused over 20 min in the treatment group. RESULTS The treatment group had greater (P < 0. 05) improvement in platelet count, prothrombin time, and fibrinogen than the control group. CONCLUSIONS We conclude that collection of fresh autologous whole blood prior to heparinization and reinfusion following CPB is associated with greater improvement of coagulation status after CPB in infants.
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The influence of hemodilution on outcome after hypothermic cardiopulmonary bypass: results of a randomized trial in infants
Jonas RA, Wypij D, Roth SJ, Bellinger DC, Visconti KJ, du Plessis AJ, Goodkin H, Laussen PC, Farrell DM, Bartlett J, et al
The Journal of Thoracic and Cardiovascular Surgery. 2003;126((6):):1765-74.
Abstract
BACKGROUND We hypothesized that cognitive impairment and hemodynamic instability after infant cardiac surgery with cardiopulmonary bypass might be exacerbated by hemodilution. METHODS In a single-center randomized trial with blinded assessment of outcomes, we compared use of 2 hemodilution protocols during hypothermic cardiopulmonary bypass with infant cardiac surgery. The primary perioperative end point was lowest cardiac index in the first 24 hours postoperatively, and primary end points at age 1 year were scores on the Psychomotor Development Index and Mental Developmental Index of the Bayley Scales. RESULTS Among 147 subjects, 74 were assigned to the lower-hematocrit strategy (21. 5% +/- 2. 9%, mean +/- SD at onset of low-flow bypass) and 73 to the higher-hematocrit strategy (27. 8% +/- 3. 2%). In intent-to-treat analyses the lower-hematocrit group had lower nadirs of cardiac index (P =. 02), higher serum lactate levels 60 minutes after cardiopulmonary bypass (P =. 03), and a greater percentage increase in total body water on the first postoperative day (P =. 006). Blood product use and adverse events were similar in the 2 groups. At age 1 year (113 children), the lower-hematocrit group had worse scores on the Psychomotor Development Index (81. 9 +/- 15. 7 vs 89. 7 +/- 14. 7, P =. 008), as well as more Psychomotor Development Index scores at least 2 SDs below the population mean (16/56 [29%] vs 5/53 [9%], P =. 01). The groups had similar Mental Developmental Index scores and findings on neurologic examination. Inferences using hematocrit as a continuous variable were similar to those based on intent-to-treat analyses. CONCLUSIONS Hemodilution to a hematocrit level in wide use for cardiopulmonary bypass and thought to be safe is associated with adverse perioperative and developmental outcomes in infants.
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A prospective randomized study comparing volume-standardized modified and conventional ultrafiltration in pediatric cardiac surgery
Thompson LD, McElhinney DB, Findlay P, Miller-Hance W, Chen MJ, Minami M, Petrossian E, Parry AJ, Reddy VM, Hanley FL
Journal of Thoracic & Cardiovascular Surgery. 2001;122((2):):220-8.
Abstract
BACKGROUND Modified ultrafiltration has been touted as superior to conventional ultrafiltration for attenuating the consequences of hemodilution after cardiac surgery with cardiopulmonary bypass in children. We conducted a prospective randomized study to test the hypothesis that modified and conventional ultrafiltration have similar clinical effects when a standardized volume of fluid is removed. METHODS From October 1998 to September 1999, 110 children weighing 15 kg or less (median weight 6.1 kg, median age 6.3 months) undergoing surgery with cardiopulmonary bypass for functionally biventricular congenital heart disease were randomized to conventional (n = 67) or arteriovenous modified ultrafiltration (n = 43) for hemoconcentration. The volume of fluid removed with both methods was standardized as a percentage of effective fluid balance (the sum of prime volume and volume added during cardiopulmonary bypass minus urine output): in patients weighing less than 10 kg, 50% of effective fluid balance was removed, whereas 60% was removed in patients weighing 10 to 15 kg. Hematocrit, hemodynamics, ventricular function, transfusion of blood products, and postoperative resource use were compared between groups. RESULTS There were no significant differences between groups in age, weight, or duration of cardiopulmonary bypass. The total volume of fluid added in the prime and during bypass was greater in patients undergoing conventional ultrafiltration than in those receiving modified ultrafiltration (205 +/- 123 vs 162 +/- 74 mL/kg; P =.05), although the difference was due primarily to a greater indexed priming volume in patients having conventional ultrafiltration. There was no difference in the percentage of effective fluid balance that was removed in the 2 groups. Accordingly, the volume of ultrafiltrate was greater in patients receiving conventional than modified ultrafiltration (95 +/- 63 vs 68 +/- 28 mL/kg; P =.01). Preoperative and postoperative hematocrit levels were 35.6% +/- 6.6% and 36.3% +/- 5.6% in patients having conventional ultrafiltration and 34.4% +/- 6.7% and 38.7% +/- 7.5% in those having modified ultrafiltration. By repeated-measures analysis of variance, patients receiving modified and conventional ultrafiltration did not differ with respect to hematocrit value (P =.87), mean arterial pressure (P =.85), heart rate (P =.43), or left ventricular shortening fraction (P =.21) from baseline to the postbypass measurements. There were no differences between groups in duration of mechanical ventilation, stay in the intensive care unit, or hospitalization. CONCLUSIONS When a standardized volume of fluid is removed, hematocrit, hemodynamics, ventricular function, requirement for blood products, and postoperative resource use do not differ between pediatric patients receiving conventional and modified ultrafiltration for hemoconcentration after cardiac surgery.
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Ultrafiltration of the priming blood before cardiopulmonary bypass attenuates inflammatory response and improves postoperative clinical course in pediatric patients
Shimpo H, Shimamoto A, Sawamura Y, Fujinaga K, Kanemitsu S, Onoda K, Takao M, Mitani Y, Yada I
Shock. 2001;16((Suppl 1):):51-4.
Abstract
The priming solution using in cardiopulmonary bypass (CPB) for infants undergoing cardiac surgery includes considerable amounts of stored blood. Our objective was to test the hypothesis that ultrafiltration (UF) of the stored blood before CPB reduces the unfavorable effects of stored blood and the production of inflammatory cytokines. Fifty pediatric patients with congenital heart defects took part in this study. The patients were randomly divided into two groups: the UF (27 pediatric patients who received UF) and control (23 pediatric patients who did not receive UF) groups. UF was performed with a polysulphone ultrafiltrator before CPB. Blood samples were collected immediately before, during, and 1 h after CPB. The levels of cytokines (TNF-alpha, IL-1beta, IL-8), NH3, and bradykinin were determined. The serum concentrations of NH3 and bradykinin decreased significantly after UF. Compared with the control group, the UF group had significantly lower cytokine production. Water balance in UF group was better than that of control group. The UF group received significantly less inotropic support and shorter duration of ventilator support and ICU stay. We conclude that removal of bradykinin and a decrease in the levels of NH3, potassium, and pH play a significant role in reducing water retention and postoperative lung injury. UF of the blood used to prime the circuit for CPB is a safe and efficient method for use in open heart surgery in small pediatric patients.