CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
Irradiated Blood Transfusions +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02483702
NCT02483702N/ACompleted

The Affect of Radiated Versus Non-Irradiated Blood on Extracellular Potassium Levels in Infants Undergoing Craniosynostosis Repair

Valley Anesthesiology Consultants·interventional·Posted Jun 29, 2015·Updated Oct 19, 2018

In Brief

A clinical study evaluating Irradiated Blood Transfusions and Non-Irradiated Blood Transfusions for Graft Versus Host Disease and 5 related conditions. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 29, 2015
Enrollment StartAug 1, 2015
Primary CompletionMay 11, 2017
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 11.0 years ago

Interventions

Irradiated Blood Transfusionsother

Same as arm description - need to collect extracellular potassium values.

Non-Irradiated Blood Transfusionsother

Same as arm description - need to collect extracellular potassium values.