Comparison Of The Two Types Of Hemostasis Management Effectiveness : Thromboelastometry (Rotem) Guided Management And Conventional Method In Newborn Congenital Cardiac Surgery Patients
Condition: Newborn Cardiac Surgery; Newborn Hemostasis
Study type: Observational

Summary: 
      Sixty consecutive newborn patients who underwent pediatric cardiac surgery from April 2022 to
      October 2023 at Basaksehir Cam and Sakura City Hospital) were included in this study. Data of
      eighty-six patients who received ROTEM guided transfusions after August 15, 2022 was
      collected. First sixteen patients were given cryoprecipitate in the middle of the Modified
      ultra-filtration (MUF) procedure according to previous conventional approach, and so these
      patients excluded. And ten patients were excluded due to the lack of information. Thirty
      patients, who received ROTEM guided transfusions compared to the prior thirty patients who
      received transfusions conventionally. There was no randomization and standardized anesthesia
      and surgical techniques were used.

      Anesthesia induction conducted with midazolam, ketamine, fentanyl, and rocuronium bromide;
      and antifibrinolytic (tranexamic acid) infusion was used during operation till the closure of
      skin. Anesthesia and cardiopulmonary bypass(CPB) anesthesia was maintained with remifentanil,
      midazolam, ketamine and rocuronium, and sevoflurane -not during bypass. Size-adapted bypass
      circuits and membrane oxygenators (FX05 oxygenators) were used. Total priming volume for the
      bypass circuit was 250 - 400 ml, consisting of red blood cell (RBC), fresh frozen plasma
      (FFP), Isolyte-S solution, mannitol, sodium bicarbonate, tranexamic acid, prednisol, and
      antibiotic. Anticoagulation during CPB was managed with 350 U/kg unfractioned heparin
      (Novo-Heparin) and additional boluses of 50 U/kg, as needed, to maintain an activated
      clotting time (ACT) of at least 450s. Heparin anticoagulation was antagonized with 3,5 mg/kg
      protamine.

      Red blood cell concentrates were transfused to maintain the haematocrit at 28 - 32% during
      cardiopulmonary bypass (CPB). Bypass was conducted under mild (core temperature 32°C ) and
      moderate (core temperature 28 °C) hypothermia. Myocardial protection was achieved with cold
      intermittent blood cardioplegia (20 ml/kg), which was prepared during CPB by adding buffered
      del nido solution (Plasma-Lyte A) in the ratio 1:4 to whole blood obtained from the arterial
      line. The cardioplegia solution was kept at 6°C before infusion. Blood sample for running
      ROTEM analysis were taken just before weaning CPB, when the core temperature of patients were
      36-37 °C. MUF was performed after weaning from CPB and 5-10 minutes before protamine
      administration, with a target haematocrit of 35-40%. After heparin antagonization, RBC
      transfusions applied with a target haematocrit of 35-40 % for non-cyanotic patients, and
      40-45% for cyanotic patients.

      We collected data on the following subject characteristics: height (cm); weight (kg); age
      (days); gender; presence of cyanosis; presence of ay genetic disorder; Aristotle score
      (1,5-25); duration of the surgical procedure (min); CPB time (min); aortic cross clamp time
      (min); the lowest core temperature during CPB; total amount of blood products transfused
      after CPB intraoperatively (ml/kg), including red blood cell concentrates, FFP, platelet
      concentrates, cryoprecipitate, and fibrinogen concentrates; total amount of blood products
      transfused after operation up to 24 h after admission to the Pediatric Cardiac Intensive Care
      Unit (PCICU) (ml/kg); total amount of chest tube drainage after operation up to 24 h after
      PCICU admission (ml/kg); 28 day survival; extracorporeal membrane oxygenator (ECMO)
      application; and need for peritoneal dialysis.

      In all patients, routine blood samples for hemoglobin (Hb), haematocrit (Hct), prothrombin
      time (PT), international normalized ratio (INR), activated partial thromboplastin time
      (aPTT), platelet count; renal function tests urea and creatinine were collected
      preoperatively. Hb, Hct, PT, INR, aPTT, platelet count, urea and creatinine were also
      analyzed on the first postoperative morning.

      We conducted thromboelastometry in the operating theatre (OR) using the ROTEM device. Four
      assays-EXTEM, INTEM, FIBTEM, and HEPTEM were tested in citrated whole blood. Because the
      patients were still under heparin effect when the samples were taken, we made transfusion
      adjustments according to EXTEM and FIBTEM test results. Since we got the EXTEM, FIBTEM A5
      results as soon as heparin antagonization was complete, we transfused the blood products
      according to the results. We also collected those data.

      The primary outcome was the proportion of perioperative transfusion (intraoperatively and in
      the PCICU) in the ROTEM group and in the conventional group. The secondary outcomes are
      postoperative chest tube drainage up to 24 hours; need for peritoneal dialysis. The other
      analyses have mainly a descriptive purpose.
    

Detailed description: 
      Four main scenarios based on clinical observation and ROTEM results were possible:

        1. Insignificant bleeding-normal ROTEM; no transfusions

        2. Insignificant bleeding-abnormal ROTEM; no transfusions

        3. Significant bleeding-normal ROTEM; surgical reevaluation

        4. Significant bleeding-abnormal ROTEM; transfusion of blood products as indicated by:

             1. FIBTEM A5 <9 mm -fibrinogen concentrate or cryoprecipitate

             2. 9mm ≤ FIBTEM A5 <13mm and or EXTEM CT > 80 seconds fibrinogen concentrate or
                cryoprecipitate and significant bleeding still continued with EXTEM A5 < 35 mm -
                platelet concentrate

             3. FIBTEM A5 >13mm and EXTEM A5 < 35 mm -platelet concentrate

             4. After transfusions if the bleeding was still continuing, while surgical
                reevaluation was in progress, we gave fibrinogen concentrate to replace the lost
                fibrinogen with the ongoing bleeding. At the same time to verify the treatment
                effect and control heparin reversal, a second set of INTEM, HEPTEM, EXTEM and
                FIBTEM analyses were also performed during wound closure. ACT was tested in all
                patients to control for heparin reversal. If patients had both a pathological ACT
                and ROTEM (CTIN/ CTHEP ratio ≥ 1,25) protamine was administered first. After
                fibrinogen and platelet transfusions, if INTEM CT > 280 seconds and HEPTEM CT > 280
                seconds with continuing bleeding FFP were given.

      Blood transfusion after paediatric intensive care unit (PCICU) admission was managed without
      ROTEM guidance by paediatric cardiac surgeons and intensivists.
    

Intervention name(s): ROTEM Guided Management
Intervention type(s): Other
Intervention description(s): ROTEM guided management of hemostasis after CPB
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Newborn patients who underwent pediatric congenital heart surgery on cardiopulmonary bypass