Irradiated Blood Versus Non Irradiated Blood Transfusions in Craniosynostosis Repair
Condition: Graft Versus Host Disease; Hyperkalemia; Craniectomy; Synostectomy; FOA; Congenital Malformations
MeSH terms: Craniosynostoses; Congenital Abnormalities; Hyperkalemia; Graft vs Host Disease
Study type: Interventional

Summary: 
      Blood transfusions are required for patients undergoing a craniosynostosis repair due to the
      significant amount of blood loss. Irradiated or non-irradiated transfusions have many risks
      involved including elevated potassium levels and graft versus host disease (TA-GVHD).
      Irradiated blood is able to destroy the leukocytes responsible for TA-GVHD, but it adversely
      causes elevated extracellular potassium due to hemolysis of the RBC's. When this blood is
      transfused, it may introduce too much extracellular potassium (> 6.5 meq/L) into the patient
      causing interference with the heart's conduction system significantly increasing the risk for
      hemodynamic changes, cardiac arrhythmias, and cardiac arrest. Hyperkalemia from rapid
      transfusions occurs much more frequently than TA-GVHD; however, both complications are
      under-reported.

      The study aims to evaluate the risk of irradiated versus non-irradiated blood in patients
      under the age of 6 months undergoing a craniosynostosis repair. This will be done by
      comparing the levels of extracellular potassium pre-transfusion, during transfusion,
      immediately after transfusion, and 30 minutes after the completion of transfusion. The
      investigators hypothesize that the patients who receive irradiated blood will have an
      increased extracellular potassium level compared to those who receive non-irradiated blood.
    

Detailed description: 
      Patients between the ages of 2 to 6 months of age and undergo a sagittal synostosis repair
      will split into two groups to participate in a prospective pilot study. The purpose of this
      study is to examine the extracellular potassium levels in patients who receive irradiated
      blood versus non-irradiated blood. Enrollment will occur over a 24 month period or until 20
      patients are enrolled. The patient names, medical record numbers and any other identifiers
      will be kept strictly confidential.

      Patients will receive irradiated or non-irradiated blood based on their age. Patients under 4
      months of age will receive irradiated blood products, as per hospital protocol, while
      patients over 4 months of age will receive non-irradiated blood products.

      Patients will receive standard surgical practice for their craniosynostosis repair and will
      receive the blood transfusion at the discretion of the anesthesiologist and surgeon. All the
      blood that is transfused will be analyzed prior to transfusion. The patient's extracellular
      potassium levels will be recorded pre-transfusion, at 30 minute intervals during the
      transfusion, and post-transfusion. The collected data will be compared to test for
      correlation between extracellular potassium levels, the type of blood transfused, and the
      amount of calcium that is administered.

      There is minimal risk of harm associated with the study. All surgical procedures run their
      typical risk of infection, bleeding or any other complication that could occur during or
      after the operation. The blood transfusions may also increase patient's risk of graft versus
      host disease, hyperkalemia, or cardiac anomalies. These cases will be documented and
      responded to according to anesthesiologist and surgeon's preference.

      Materials and information necessary to carry out this experiment include: patient age, sex,
      weight, type of blood transfused (ABO and non-irradiated/irradiated), vital signs, operating
      time, amount of blood lost, adverse events, and length of stay.

      Patients who decline participation in the study will have no change in their anesthetic or
      post-operative care.
    

Intervention name(s): Irradiated Blood Transfusions; Non-Irradiated Blood Transfusions
Intervention type(s): Other; Other
Intervention description(s): Same as arm description - need to collect extracellular potassium values.; Same as arm description - need to collect extracellular potassium values.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Irradiated Blood; Non-Irradiated Blood; graft versus host disease; TA-GVHD; potassium; Blood transfusion