Use of ROTEM® in Pediatric Cardiac Surgical Patients
Condition: Congenital Heart Defect
MeSH terms: Heart Defects, Congenital
Study type: Observational

Summary: 
      Cardiac surgery requiring use of a heart-lung machine, also known as cardiopulmonary bypass
      (CPB) can induce abnormalities in blood coagulation (clotting) that lead to excessive blood
      loss during and after operation. While of significant concern in adults, this problem takes
      on even greater importance in children due to the simple fact that they have a smaller blood
      volume. It is well known that if a child has previously undergone a heart operation, they are
      at increased risk of bleeding should more cardiac surgery be required ("reoperation"). The
      processes regulating blood coagulation are extraordinarily complex, and little is known about
      the exact mechanisms that contribute to the increased bleeding associated with cardiac
      reoperation in children. Rotational thromboelastometry (ROTEM®) is a technology that can
      provide, at the bedside, detailed information about coagulation abnormalities. While not
      currently approved for general use in the United States, in Europe ROTEM® has been used to
      guide administration of the blood products in surgery based upon determination of specific
      coagulation abnormalities. Importantly, there is now evidence that guidelines for transfusion
      therapy based on ROTEM® reduce transfusion requirements thus decreasing patient exposure to
      blood products. Whether the use of ROTEM® has potential benefit for pediatric cardiac
      surgical patients has not been studied. Accordingly, the present study was designed to
      provide preliminary data comparing coagulation profiles between children undergoing cardiac
      reoperation to those having primary procedure.

      The investigators hypothesize that ROTEM® analysis will detect a pattern of impaired
      coagulation in children undergoing reoperation. The overall objective of the four assays of
      ROTEM® analysis therefore, is to provide information that can be used to devise a rational
      transfusion protocol for pediatric cardiac surgical subjects.
    

Detailed description: 
      Specific aims of the proposed pilot studies are to:

        1. Use bedside blood analysis with ROTEM® in pediatric cardiac surgical patients to provide
           preliminary information on the nature of coagulation abnormalities.

        2. Compare ROTEM® coagulation profiles between subjects having primary surgery and those
           undergoing reoperation.

      In order to test the study hypothesis, pediatric subjects scheduled to undergo cardiac
      surgery involving CPB will be recruited for two study groups: a) primary surgery; b)
      reoperation. For each group, a small amount of blood will be obtained for ROTEM® analysis
      after induction of anesthesia but before skin incision and again following Cardiopulmonary
      Bypass, 5 minutes after protamine administration.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Minors from the ages 1-6 years old receiving cardiac surgery using a cardiopulmonary bypass
        machine
      
Biospecimen description: 
      For each group, a small amount of blood will be obtained for ROTEM® analysis after induction
      of anesthesia but before skin incision and again following cardiopulmonary bypass, 5 minutes
      following protamine administration.