Clinical trial NCT02483702: Irradiated Blood Versus Non Irradiated Blood Transfusions in Craniosynostosis Repair
Official title: The Affect of Radiated Versus Non-Irradiated Blood on Extracellular Potassium Levels in Infants Undergoing Craniosynostosis Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Graft Versus Host Disease
Hyperkalemia
Craniectomy
Synostectomy
FOA
Congenital Malformations
Keywords: Irradiated Blood
Non-Irradiated Blood
graft versus host disease
TA-GVHD
potassium
Blood transfusion
Lead sponsor: Valley Anesthesiology Consultants
Sponsor class: OTHER
First posted: 2015-06-29
Enrollment: 20
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Must be between 2-6 m/o
* Must be undergoing a craniosynostosis repair
* Must require a blood transfusion

Exclusion Criteria:

* n/a

Primary outcomes:
measure: Change in extracellular potassium values.
timeFrame: immediately after transfusion and 30 minutes after the end of transfusion
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
Study officials:
References:
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citation: Faberowski LW, Black S, Mickle JP. Blood loss and transfusion practice in the perioperative management of craniosynostosis repair. J Neurosurg Anesthesiol. 1999 Jul;11(3):167-72. doi: 10.1097/00008506-199907000-00002.