Fibrinogen Concentrate vs Cryoprecipitate
Condition: Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Interventional
Phase: Phase 4

Summary: 
      One of the most common hemostatic derangements in pediatric open- heart surgery is an acute
      acquired hypofibrinogenemia. This compromises fibrin clot generation and platelet
      aggregation, resulting in increased bleeding and allogenic blood transfusions.

      Currently, fresh frozen plasma and cryoprecipitate are used to supplement fibrinogen in
      pediatric cardiac patients. We propose that replacing cryoprecipitate with fibrinogen
      concentrate will be as effective in treating post-CPB bleeding and will decrease total blood
      product exposure when used as part of a blood transfusion algorithm.

      We plan to include all patients undergoing cardiac surgery on CPB less than 12 months and a
      fibrinogen level <250mg/dL while on bypass.

      We hope to demonstrate that fibrinogen concentrate is at least as effective as the standard
      of care in the management of peri- operative bleeding in neonatal patients undergoing
      cardiopulmonary bypass. If we are able to demonstrate that fibrinogen is at least as
      effective as the standard of care, then we would plan a multi-center trial to demonstrate the
      safety and efficacy of this medication. If we are able to demonstrate that fibrinogen
      concentrate is effective, fibrinogen concentrate could replace allogenic products and
      potentially decrease transfusion related morbidity in mortality in this population.
    

Detailed description: 
      Patients under 12 months of age requiring cardiopulmonary bypass surgery will be approached
      for the study. Patients with a pre- existing coagulopathy, including unexplained bleeding or
      history of clotting, will be excluded. Prior to the study beginning, patients will be
      randomized to our standard transfusion algorithm with cryoprecipitate or fibrinogen
      concentrate. As is standard of care, laboratory tests will be sent at standard times points

        1. after the induction of anesthesia,

        2. after initiation of bypass,

        3. after separation from bypass and administration of protamine, and transfusion of either
           fibrinogen concentrate or cryoprecipitate

        4. on arrival to the ICU. These laboratory tests include hematocrit, arterial blood gas,
           chemistry, thromboelastogram (TEG) and fibrinogen. Additional laboratory tests will be
           sent as indicated by the clinical scenario to determine transfusion requirements. For
           patients enrolled in the study, we will standardize the anesthetic management,
           cardiopulmonary bypass protocol, and transfusion thresholds in the operating room and
           ICU. We will collect demographic data, intraop and post-op laboratory values, bypass
           times, intraop and post op transfusion data, chest tube output, adverse events, and
           length of ventilation, ICU stay and hospital stay.

      For patients randomized to the study arm (fibrinogen concentrate), the fibrinogen level
      measured on bypass will be used to calculate the appropriate dose of fibrinogen concentrate
      to achieve a level of 300mg/dL after separation from bypass. Fibrinogen concentrate will
      replace cryoprecipitate in our post-operative transfusion algorithm. If the patient has
      continued bleeding based on laboratory values and clinical situation, the patient will be
      given cryoprecipitate as a rescue measure. Patients not on the study protocol will receive
      our normal transfusion algorithm.
    

Intervention name(s): Fibrinogen Concentrate; Cryoprecipitate
Intervention type(s): Biological; Biological
Intervention description(s): Subject will be administered Fibrinogen Concentrate to control bleeding after open heart surgery when randomized to Fibrinogen Concentrate group; Subject will be administered Cryoprecipitate to control bleeding after open heart surgery when randomized to Cryoprecipitate group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment