Nils Dennhardt1, Robert Sümpelmann2, Alexander Horke3, Oliver Keil2, Katja Nickel2, Sebastian Heiderich2, Dietmar Boethig3, Christiane E Beck2. 1. Clinic for Anaesthesiology and Intensive Care Medicine, Hannover Medical School, OE 8050, Carl-Neuberg-Str. 1, D-30625, Hannover, Germany. Dennhardt.Nils@mh-hannover.de. 2. Clinic for Anaesthesiology and Intensive Care Medicine, Hannover Medical School, OE 8050, Carl-Neuberg-Str. 1, D-30625, Hannover, Germany. 3. Clinic for Cardiac, Thoracic, Transplant and Vascular Surgery, Hannover Medical School, Carl-Neuberg-Str. 1, D-30625, Hannover, Germany.
Abstract
BACKGROUND: Postoperative bleeding is a major problem in children undergoing complex pediatric cardiac surgery. The primary aim of this prospective observational study was to evaluate the effect of an institutional approach consisting of early preventive fibrinogen, prothrombin complex and platelets administration on coagulation parameters and postoperative bleeding in children. The secondary aim was to study the rate of re-intervention and postoperative transfusion, the occurrence of thrombosis, length of mechanical ventilation, ICU stay and mortality. METHODS: In fifty children (age 0-6 years) with one or more predefined risk factors for bleeding after cardiopulmonary bypass (CPB), thrombelastography (TEG) and standard coagulation parameters were measured at baseline (T1), after CPB and reversal of heparin (T2), at sternal closure (T3) and after 12 h in the ICU (T4). Clinical bleeding was evaluated by the surgeon at T2 and T3 using a numeric rating scale (NRS, 0-10). RESULTS: After CPB and early administration of fibrinogen, prothrombin complex and platelets, the clinical bleeding evaluation score decreased from a mean value of 6.2 ± 1.9 (NRS) at T2 to a mean value of 2.1 ± 0.8 at T3 (NRS; P < 0.001). Reaction time (R), kinetic time (K), maximum amplitude (MA) and maximum amplitude of fibrinogen (MA-fib) improved significantly (P < 0.001 for all), and MA-fib correlated significantly with the clinical bleeding evaluation (r = 0.70, P < 0.001). The administered total amount of fibrinogen (mg kg- 1) correlated significantly with weight (r = - 0.42, P = 0.002), priming volume as percentage of estimated blood volume (r = 0.30, P = 0.034), minimum CPB temperature (r = - 0.30, P = 0.033) and the change in clinical bleeding evaluation from T2 to T3 (r = 0.71, P < 0.001). The incidence of postoperative bleeding (> 10% of estimated blood volume) was 8%. No child required a surgical re-intervention, and no cases of thrombosis were observed. Hospital mortality was 0%. CONCLUSION: In this observational study of children with an increased risk of bleeding after CPB, an early preventive therapy with fibrinogen, prothrombin complex and platelets guided by clinical bleeding evaluation and TEG reduced bleeding and improved TEG and standard coagulation parameters significantly, with no occurrence of thrombosis or need for re-operation. TRIAL REGISTRATION: German Clinical Trials Register DRKS00018109 (retrospectively registered 27th August 2019).
BACKGROUND:Postoperative bleeding is a major problem in children undergoing complex pediatric cardiac surgery. The primary aim of this prospective observational study was to evaluate the effect of an institutional approach consisting of early preventive fibrinogen, prothrombincomplex and platelets administration on coagulation parameters and postoperative bleeding in children. The secondary aim was to study the rate of re-intervention and postoperative transfusion, the occurrence of thrombosis, length of mechanical ventilation, ICU stay and mortality. METHODS: In fifty children (age 0-6 years) with one or more predefined risk factors for bleeding after cardiopulmonary bypass (CPB), thrombelastography (TEG) and standard coagulation parameters were measured at baseline (T1), after CPB and reversal of heparin (T2), at sternal closure (T3) and after 12 h in the ICU (T4). Clinical bleeding was evaluated by the surgeon at T2 and T3 using a numeric rating scale (NRS, 0-10). RESULTS: After CPB and early administration of fibrinogen, prothrombincomplex and platelets, the clinical bleeding evaluation score decreased from a mean value of 6.2 ± 1.9 (NRS) at T2 to a mean value of 2.1 ± 0.8 at T3 (NRS; P < 0.001). Reaction time (R), kinetic time (K), maximum amplitude (MA) and maximum amplitude of fibrinogen (MA-fib) improved significantly (P < 0.001 for all), and MA-fib correlated significantly with the clinical bleeding evaluation (r = 0.70, P < 0.001). The administered total amount of fibrinogen (mg kg- 1) correlated significantly with weight (r = - 0.42, P = 0.002), priming volume as percentage of estimated blood volume (r = 0.30, P = 0.034), minimum CPB temperature (r = - 0.30, P = 0.033) and the change in clinical bleeding evaluation from T2 to T3 (r = 0.71, P < 0.001). The incidence of postoperative bleeding (> 10% of estimated blood volume) was 8%. No child required a surgical re-intervention, and no cases of thrombosis were observed. Hospital mortality was 0%. CONCLUSION: In this observational study of children with an increased risk of bleeding after CPB, an early preventive therapy with fibrinogen, prothrombincomplex and platelets guided by clinical bleeding evaluation and TEG reduced bleeding and improved TEG and standard coagulation parameters significantly, with no occurrence of thrombosis or need for re-operation. TRIAL REGISTRATION: German Clinical Trials Register DRKS00018109 (retrospectively registered 27th August 2019).
Authors: Wolfgang Boettcher; Frank Dehmel; Mathias Redlin; Oliver Miera; Michele Musci; Mi-Young Cho; Joachim Photiadis Journal: J Extra Corpor Technol Date: 2017-06