ABSTRACT
BACKGROUND: Unbalanced fluid solutions cause metabolic acidosis and could be associated with impaired coagulation and increased blood loss. OBJECTIVE: To investigate whether the use of a balanced colloid compared with a saline colloid for peri-operative fluid therapy in children undergoing cardiac surgery is associated with decreased blood loss and exposure to blood products. DESIGN: Double-blinded randomised controlled trial. SETTING: Tertiary children's hospital from 2013 to 2016. PATIENTS: Children older than 29âdays and younger than 3âyears admitted for cardiac surgery with cardiopulmonary bypass (CPB). Exclusion criteria were emergency cardiac surgery, moribund (American Society of Anesthesiologists 5), Jehovah's witnesses, coagulopathy, renal failure, liver injury, intracranial haemorrhage and electrolyte disturbances. From the 128 patients eligible, 88 were included in the study. INTERVENTION: Random assignment of patients to either a saline colloid (6% hydroxyethyl starch 130/0.4 in 0.9% NaCl) or a balanced-electrolyte colloid (6% hydroxyethyl starch 130/0.4 in an isotonic solution) for CPB priming and intra- and postoperative fluid therapy during the first postoperative 48âh. MAIN OUTCOME MEASURE: The primary outcome measure was calculated blood loss until the third postoperative day (POD3). RESULTS: A total of 44 patients were included in each study arm. Calculated blood loss at POD3 was not significantly different between the groups (saline colloid 19.9 [IQR 13.8 to 26.1] ml kg-1 versus balanced colloid 15.9 [IQR 9.0 to 25.3âmlâkg-1], Pâ=â0.409). Secondary outcomes related to bleeding, exposure to blood products and coagulation were not different between groups. There was also no difference in length of mechanical ventilation, intensive care and hospital length of stay between groups. CONCLUSION: The use of a balanced colloid for peri-operative fluid therapy compared with a saline one is not associated with decreased blood loss or exposure to blood products. TRIAL REGISTRATION: EudraCT identifier: 2012-006034-17 and ClinicalTrial.gov identifier: NCT02584868.
Subject(s)
Blood Loss, Surgical , Cardiac Surgical Procedures , Blood Loss, Surgical/prevention & control , Cardiac Surgical Procedures/adverse effects , Child , Colloids , Fluid Therapy , Humans , Hydroxyethyl Starch Derivatives/adverse effects , Isotonic SolutionsABSTRACT
OBJECTIVES: The upcoming release of aprotinin in paediatric cardiac surgery prompted a re-evaluation of its use in comparison to tranexamic acid (TXA) focusing on their effect on exposure to blood transfusions as well as severe postoperative morbidity or mortality. METHODS: This retrospective study was conducted in a tertiary children hospital from 2002 to 2015. Patients receiving aprotinin (Aprotinin group: 2002-2007) were compared with those receiving TXA group (2008-2015) using propensity score analysis. Primary outcome measures were 'exposure to blood products' and 'severe postoperative morbidity or mortality'. High-risk subgroups that included neonates, complex (Risk Adjusted Classification for Congenital Heart Surgery-1 ≥ 3) and redo surgery were also analysed. RESULTS: The study included 2157 patients, 1136 in the Aprotinin group and 1021 in the TXA group. Exposure to blood products was significantly higher in the Aprotinin group (78% vs 60%; P < 0.001) as well as in the complex and redo surgery subgroups. Incidence of mortality and/or severe morbidity was higher in the Aprotinin group (33% vs 28%; P = 0.007), as well as in the neonate group. However, cardiopulmonary bypass priming volume and intraoperative fluid balance were significantly decreased, and the use of modified ultrafiltration significantly increased in the TXA group. CONCLUSIONS: In our population, children receiving aprotinin were more frequently transfused and were at a higher risk of developing severe postoperative morbidity or mortality than those receiving TXA. Subgroups at high risk of bleeding or inflammation did not seem to benefit from aprotinin. These differences might be explained by a safer profile of TXA, but also attributed to major changes in our patient blood management strategies over years.
Subject(s)
Antifibrinolytic Agents/therapeutic use , Aprotinin/therapeutic use , Blood Transfusion/statistics & numerical data , Cardiac Surgical Procedures , Hemostatics/therapeutic use , Postoperative Complications/epidemiology , Tranexamic Acid/therapeutic use , Child, Preschool , Female , Humans , Infant , Male , Retrospective StudiesABSTRACT
OBJECTIVES: Cyanotic heart disease is associated with increased risk of bleeding in children undergoing cardiac surgery. We studied if the presence of a cyanotic heart disease was an independent predictive factor for fresh frozen plasma (FFP) and platelets transfusion in these patients. In children with ROTEM measurements, we also tried to characterize the coagulation profile between both groups. DESIGN: Retrospective observational study. SETTING: Tertiary university hospital; single center. PARTICIPANTS: All consecutive children admitted for cardiac surgery with cardiopulmonary bypass (CPB) from January 2006 to December 2014. Patients who received FFP in the CPB priming were excluded. Multivariate logistic regression was used to determine the predictive factors for FFP and platelet transfusions. INTERVENTION: none. MEASUREMENTS AND MAIN RESULTS: From the 1846 patients included for analysis: 1063 were acyanotic and 783 were cyanotic. The presence of cyanotic heart disease was an independent predicting factor for both FFP (OR: 2.09; 95%CI: 1.44-3.02) and platelets (OR:3.98; 95%CI: 2.28-6.70) transfusion. Cyanotic children exhibited also higher perioperative blood losses [Intraoperative: 31.1 (17.6-50.4) versus 26.7 (14.8-44.7); P < 0.001 and Postoperative: 31.2 (19.1-51.9) versus 16.9 (10.4-26.9); P < 0.001]. Thromboelastometry assays after separation from CPB and heparin reversal revealed more complex coagulation disturbances in cyanotic than acyanotic children. CONCLUSION: Children with a cyanotic heart disease are at higher risk of FFP and platelet transfusion after cardiac surgery. Intraoperative monitoring should be used to guide administration of blood and haemostatic product in this population at high risk of postoperative bleeding.