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Irradiated Blood Versus Non Irradiated Blood Transfusions in Craniosynostosis Repair

NCT02483702 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2018-10-19

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Irradiated Blood Transfusions

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

OTHER

Non-Irradiated Blood Transfusions

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

Sponsors & Collaborators

  • Valley Anesthesiology Consultants

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
6 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2017-05-11
Completion
2017-05-11

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02483702 on ClinicalTrials.gov