Rotational Thromboelastometry (ROTEM) TRUE-NATEM Reference Value Validation in Liver Transplantation
Condition: Coagulation in Liver Transplantation
Study type: Observational

Summary: 
      Background: Rotational thromboelastometry (ROTEM) has been used widely in liver
      transplantation for coagulation management. However, a TRUE-NATEM (TRUE-Non-Activated
      Rotational Thromboelastometry) reference value has never been established. A TRUE-NATEM value
      is of clinical significance since no coagulation activators or reagents will be added to the
      blood sample for analysis. Therefore, the result will reflect the true coagulation profile of
      the patient.

      Methods: Non-citrated whole blood will be used for analysis. Blood will be drawn from the
      patient and transferred into a plastic reagent cup that has no reagent. Test will be
      performed within 4 minutes of blood draw to avoid activation of coagulation. Primary outcome
      measure will be clotting time (CT), clot formation time (CFT) and maximum clot firmness
      (MCF). The specific aims of the study are to establish a TRUE-NATEM reference value using
      Rotational Thromboelastometry (ROTEM®) in patients undergoing liver transplantation. Our
      hypothesis is that clotting time (CT), clot formation time (CFT) is prolonged and maximum
      clot firmness (MCF) decreased compared to healthy volunteers in patient undergoing liver
      transplantation due to synthetic coagulation factor deficiency.
    

Detailed description: 
      This study is a prospective cohort study establishing a TRUE-NATEM reference value using
      Rotational Thromboelastometry (ROTEM®) in patients undergoing liver transplantation.

      The study population will include 20 adults (age range of 18 - 75 years) who are undergoing
      liver transplantation. Inclusion criteria are patients undergoing liver transplantation with
      English as their native language.

      Exclusion criteria include patient's refusal, or on medical anticoagulation therapy. Informed
      consents will be obtained from the patients who agree to participate in this clinical study.

      Currently, all patients undergoing liver transplantation will have hourly ROTEM analysis as
      standard of care. An additional TRUE-NATEM test will be performed after induction if
      anesthesia. 5 mL of whole blood will be obtained via a preexisting peripheral IV catheter or
      arterial line using a sterile technique. The blood will be transferred into a plastic reagent
      cup that has no additives. Test will be performed within 4 minutes of blood draw.3 All
      patients will undergo the standard anesthesia care and intraoperative coagulation monitoring
      and blood transfusion will be carried out using the standard practice guideline of the TJUH.

      The control population will include 20 adult volunteers (age 18-65 years) who meet the in the
      American Society of Anesthesiologists (ASA) Physical Status (PS) Classes 1 criteria.
      Exclusion criteria will be refusal, volunteers on any medication or significant history of
      bleeding.

      In the control group 5 mL of whole blood will be obtained after placing a peripheral IV
      catheter using a sterile technique. Blood draw from steel needle will be avoided because
      steel will activate coagulation. The blood will be transferred into a plastic reagent cup
      that has no additives. Test will be performed within 4 minutes of blood draw.

      For each patient and control group four channels of ROTEM (TRUE-NATEM, NATEM, INTEM, EXTEM,)
      will be performed following the standard guideline at the Anesthesiology Coagulation
      Laboratory by a certified ROTEM specialists. Primary outcome measure will be clotting time
      (CT), clot formation time (CFT) and maximum clot firmness (MCF). The following demographic
      information will be collected; ASA physical status, age, height, weight, gender, home
      medication use, past medical history, and past surgical history.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study population will include 20 adults (age range of 18 - 75 years) who are undergoing
        liver transplantation.
      
Biospecimen description: 
      Patients whole blood
    
Keywords: ROTEM; Rotational Thromboelastometry; NATEM; TRUE-NATEM; Coagulation; liver transplantation