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Irradiated Blood Versus Non Irradiated Blood Transfusions in Craniosynostosis Repair

Primary Purpose

Graft Versus Host Disease, Hyperkalemia, Craniectomy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Irradiated Blood Transfusions
Non-Irradiated Blood Transfusions
Sponsored by
Valley Anesthesiology Consultants
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Graft Versus Host Disease focused on measuring Irradiated Blood, Non-Irradiated Blood, graft versus host disease, TA-GVHD, potassium, Blood transfusion

Eligibility Criteria

2 Months - 6 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • n/a

Sites / Locations

  • Phoenix Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Patients under 4 months Receive Irradiated Blood

Patients Over 4 Months Recieve Non-Irradiated Blood

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 22, 2015
Last Updated
October 17, 2018
Sponsor
Valley Anesthesiology Consultants
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1. Study Identification

Unique Protocol Identification Number
NCT02483702
Brief Title
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

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
May 11, 2017 (Actual)
Study Completion Date
May 11, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Valley Anesthesiology Consultants

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients under 4 months Receive Irradiated Blood
Arm Type
Experimental
Arm Description
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.
Arm Title
Patients Over 4 Months Recieve Non-Irradiated Blood
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Irradiated Blood Transfusions
Intervention Description
Same as arm description - need to collect extracellular potassium values.
Intervention Type
Other
Intervention Name(s)
Non-Irradiated Blood Transfusions
Intervention Description
Same as arm description - need to collect extracellular potassium values.
Primary Outcome Measure Information:
Title
Change in extracellular potassium values.
Description
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.
Time Frame
immediately after transfusion and 30 minutes after the end of transfusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21404983
Citation
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.
Results Reference
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PubMed Identifier
8430450
Citation
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.
Results Reference
background
PubMed Identifier
11972509
Citation
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.
Results Reference
background
PubMed Identifier
23581425
Citation
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.
Results Reference
background
PubMed Identifier
12100387
Citation
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.
Results Reference
background
PubMed Identifier
16078915
Citation
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. Erratum In: Transfusion. 2006 Aug;46(8):1461.
Results Reference
background
PubMed Identifier
23690124
Citation
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.
Results Reference
background
PubMed Identifier
21498041
Citation
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.
Results Reference
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PubMed Identifier
10414670
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.
Results Reference
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Irradiated Blood Versus Non Irradiated Blood Transfusions in Craniosynostosis Repair

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