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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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Indications and outcomes of cell saver in adolescent scoliosis correction surgery: a systematic review
Stone N, Sardana V, Missiuna P
Spine. 2016;42((6):):E363-E370
Abstract
STUDY DESIGN Systematic Review. OBJECTIVE To determine the indications and outcomes for intraoperative cell salvage during adolescent scoliosis correction surgery by systematically reviewing all available evidence. SUMMARY OF BACKGROUND DATA Several blood conservation strategies exist to minimize the consequences of blood loss due to scoliosis correction surgery. The utility of intraoperative cell salvage has been contested in the literature with respect to benefits and cost. High quality randomized control trials are needed to help surgeons make an informed decision about including Cell Saver into their practice. METHODS The databases Medline, Embase, Ovid Healthstar, and PubMed were searched for English language literature investigating Cell Saver use during adolescent scoliosis correction surgery, mean ages 10-19 inclusively. Qualitative and quantitative findings from relevant studies are presented. RESULTS There were seven eligible studies that directly compared the use of Cell Saver (349 patients) against a Control (non-Cell Saver) group (244 patients). The majority of the demographic and hematologic data were consistent between both groups. The average volume of blood that was re-infused into patients in the Cell Saver group was 453.8 ml. Patients in the Cell Saver group received significantly fewer allogenic blood transfusions than the Control group, with 32.6% less intraoperatively, 45.9% less postoperatively, and 47.3% less perioperatively. On average, Cell Saver patients received 1.0 fewer unit of allogenic blood compared to the Control group patients. CONCLUSION Cell Saver reduces the demand for allogenic transfusion. This review supports the use of Cell Saver if the associated monetary costs are expected to be less than the cost of transfusing one unit of allogenic blood. LEVEL OF EVIDENCE 4.
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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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Reducing blood transfusion requirements in preterm infants by a new device: a pilot study
Ballin A, Livshiz V, Mimouni FB, Dollberg S, Kohelet D, Oren A, Arbel E, Boaz M, Tal A, Matas Z, et al
Acta Paediatrica (Oslo, Norway : 1992). 2009;98((2):):247-50.
Abstract
OBJECTIVE To test a new device designed to salvage red blood cells (RBCs) from blood samples drawn from preterm infants, with the intent of decreasing blood loss and lowering the requirements for RBC transfusions. DESIGN A case-controlled pilot study was conducted in two Israeli neonatal intensive care units in large municipal hospitals. Twenty low-birthweight preterm infants were randomly and equally divided into the ErythroSave group or a control group. All blood tests in the study group (except for complete blood count and coagulation parameters) were obtained during the first week of life by the new device in the study group and by ordinary syringes in the control group. The main outcome measure was the total number of units of blood needed. RESULTS The average volume of blood obtained for laboratory analyses from each infant was 27 mL in the ErythroSave group and 24 mL in controls (not significant). The average volume of transfused packed cells was 6. 4 mL for the ErythroSave group and 21. 3 mL for the controls (p = 0. 008). CONCLUSION The use of ErythroSave for sampling blood significantly reduced blood transfusion requirements in premature infants compared to sampling by conventional syringes.
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Successful blood conservation during craniosynostotic correction with dual therapy using procrit and cell saver
Krajewski K, Ashley RK, Pung N, Wald S, Lazareff J, Kawamoto HK, Bradley JP
The Journal of Craniofacial Surgery. 2008;19((1):):101-5.
Abstract
BACKGROUND Craniosynostotic correction typically performed around infant physiologic nadir of hemoglobin (approximately 3-6 months of age) is associated with high transfusion rates of packed red blood cells and other blood products. As a blood conserving strategy, we studied the use of 1) recombinant human erythropoietin or Procrit (to optimize preoperative hematocrit) and 2) Cell Saver (to recycle the slow, constant ooze of blood during the prolonged case). METHODS UCLA Patients with craniosynostosis from 2003-2005 were divided into 1) the study group (Procrit and Cell Saver) or 2) the control group (n = 79). The study group 1) received recombinant human erythropoietin at 3 weeks, 2 weeks, and 1 week preoperatively and 2) used Cell Saver intraoperatively. Outcomes were based on morbidities and transfusion rate comparisons. RESULTS The 2 groups were comparable with regards to age (5. 66 and 5. 71 months), and operative times (3. 11 vs 2. 59 hours). In the study group there was a marked increase in preoperative hematocrit (56. 2%). The study group had significantly lower transfusions rates (5% vs 100% control group) and lower volumes transfused than in the control group (0. 05 pediatric units vs 1. 74 pediatric units). Additionally, of the 80% of patients in the study group who received Cell Saver blood at the end of the case, approximately 31% would have needed a transfusion if the recycled blood were unavailable. CONCLUSION Our data showed that for elective craniosynostotic correction, successful blood conserving dual therapy with Procrit and Cell Saver might be used to decrease transfusion rates and the need for any blood products.
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Efficacy and safety of acute normovolemic hemodilution in pediatric abdominal and orthopedic surgery
Andonova A, Gavrilova N, Kotzeva S, Jekova N
Transfusion Alternatives in Transfusion Medicine. 2008;10((Suppl 1):):37. Abstract No. P49.
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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.