Irradiated Blood Versus Non Irradiated Blood Transfusions in Craniosynostosis Repair
| Status: | Completed |
|---|---|
| Conditions: | Other Indications, Orthopedic, Women's Studies, Hematology |
| Therapuetic Areas: | Hematology, Orthopedics / Podiatry, Other, Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 10/21/2018 |
| Start Date: | August 2015 |
| End Date: | May 11, 2017 |
The Affect of Radiated Versus Non-Irradiated Blood on Extracellular Potassium Levels in Infants Undergoing Craniosynostosis Repair
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.
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.
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.
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.
Inclusion Criteria:
- Must be between 2-6 m/o
- Must be undergoing a craniosynostosis repair
- Must require a blood transfusion
Exclusion Criteria:
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