Irradiated Blood Versus Non Irradiated Blood Transfusions in Craniosynostosis Repair

NCT02483702 | Completed

• 1 other identifier: 15-063
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Change in extracellular potassium values.

  We hope to determine if irradiated blood will pose a greater risk for hyperkalemia than non-irradiated blood products. This will be done by looking at potassium values immediately after transfusion and again 30 minutes after the end of transfusion.

  immediately after transfusion and 30 minutes after the end of transfusion

Study Arms (2)

Patients under 4 months Receive Irradiated Blood

EXPERIMENTAL

Patients under 4 months of age will receive irradiated blood products, as per hospital protocol. 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.

Other: Irradiated Blood Transfusions

Patients Over 4 Months Recieve Non-Irradiated Blood

EXPERIMENTAL

Patients over 4 months of age will receive non-irradiated blood products. 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.

Other: Non-Irradiated Blood Transfusions

Interventions

Irradiated Blood Transfusions OTHER

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

Patients under 4 months Receive Irradiated Blood

Non-Irradiated Blood Transfusions OTHER

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

Patients Over 4 Months Recieve Non-Irradiated Blood

Eligibility Criteria

• Age: 2 Months - 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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:

• n/a

Sponsors & Collaborators

• Valley Anesthesiology Consultants: lead

Study Sites (1)

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

Location

Related Publications (9)

• Sharma S, Sharma P, Tyler LN. Transfusion of blood and blood products: indications and complications. Am Fam Physician. 2011 Mar 15;83(6):719-24.

  PMID: 21404983 BACKGROUND

• Rosen NR, Weidner JG, Boldt HD, Rosen DS. Prevention of transfusion-associated graft-versus-host disease: selection of an adequate dose of gamma radiation. Transfusion. 1993 Feb;33(2):125-7. doi: 10.1046/j.1537-2995.1993.33293158043.x.

  PMID: 8430450 BACKGROUND

• Schroeder ML. Transfusion-associated graft-versus-host disease. Br J Haematol. 2002 May;117(2):275-87. doi: 10.1046/j.1365-2141.2002.03450.x. No abstract available.

  PMID: 11972509 BACKGROUND

• Lee AC, Reduque LL, Luban NL, Ness PM, Anton B, Heitmiller ES. Transfusion-associated hyperkalemic cardiac arrest in pediatric patients receiving massive transfusion. Transfusion. 2014 Jan;54(1):244-54. doi: 10.1111/trf.12192. Epub 2013 Apr 15.

  PMID: 23581425 BACKGROUND

• Bontadini A, Tazzari PL, Manfroi S, Tassi C, Conte R. Apoptosis in leucodepleted packed red blood cells. Vox Sang. 2002 Jul;83(1):35-41. doi: 10.1046/j.1423-0410.2002.00191.x.

  PMID: 12100387 BACKGROUND

• Weiskopf RB, Schnapp S, Rouine-Rapp K, Bostrom A, Toy P. Extracellular potassium concentrations in red blood cell suspensions after irradiation and washing. Transfusion. 2005 Aug;45(8):1295-301. doi: 10.1111/j.1537-2995.2005.00220.x.

  PMID: 16078915 BACKGROUND

• Olson J, Talekar M, Sachdev M, Castellani W, De la Cruz N, Davis J, Liao J, George M. Potassium changes associated with blood transfusion in pediatric patients. Am J Clin Pathol. 2013 Jun;139(6):800-5. doi: 10.1309/AJCP2MP8OIIXNKXF.

  PMID: 23690124 BACKGROUND

• Vraets A, Lin Y, Callum JL. Transfusion-associated hyperkalemia. Transfus Med Rev. 2011 Jul;25(3):184-96. doi: 10.1016/j.tmrv.2011.01.006. Epub 2011 Apr 17.

  PMID: 21498041 BACKGROUND

• 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.

  PMID: 10414670 BACKGROUND

MeSH Terms

Conditions

Graft vs Host Disease; Hyperkalemia; Congenital Abnormalities

Condition Hierarchy (Ancestors)

Immune System Diseases; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research

Study Record Dates

• First Submitted: June 22, 2015
• First Posted: June 29, 2015
• Study Start: August 1, 2015
• Primary Completion: May 11, 2017
• Study Completion: May 11, 2017
• Last Updated: October 19, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)