Irradiated Blood Versus Non Irradiated Blood Transfusions in Craniosynostosis Repair

Completed · Not applicable

Conditions studied: Graft Versus Host Disease, Hyperkalemia, Craniectomy, Synostectomy, FOA, Congenital Malformations

In brief

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.

Key facts

Study ID: NCT02483702
Run by: Valley Anesthesiology Consultants
People needed: 20
Starts: 2015-08-01
Expected to finish: 2017-05-11
Last updated by the study team: 2018-10-19

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

Where it is running

Phoenix Children's Hospital — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.