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Trial record 21 of 27 for:    "craniosynostoses" OR "muenke syndrome"

Irradiated Blood Versus Non Irradiated Blood Transfusions in Craniosynostosis Repair

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ClinicalTrials.gov Identifier: NCT02483702
Recruitment Status : Recruiting
First Posted : June 29, 2015
Last Update Posted : November 3, 2016
Sponsor:
Information provided by (Responsible Party):
Neil Raj Singhal, Valley Anesthesiology Consultants

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.


Condition or disease Intervention/treatment Phase
Graft Versus Host Disease Hyperkalemia Craniectomy Synostectomy FOA Congenital Malformations Other: Irradiated Blood Transfusions Other: Non-Irradiated Blood Transfusions Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Affect of Radiated Versus Non-Irradiated Blood on Extracellular Potassium Levels in Infants Undergoing Craniosynostosis Repair
Study Start Date : August 2015
Estimated Primary Completion Date : August 2017


Arm Intervention/treatment
Experimental: Patients under 4 months Receive Irradiated Blood
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
Same as arm description - need to collect extracellular potassium values.

Experimental: Patients Over 4 Months Recieve Non-Irradiated Blood
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
Same as arm description - need to collect extracellular potassium values.




Primary Outcome Measures :
  1. Change in extracellular potassium values. [ Time Frame: immediately after transfusion and 30 minutes after the end of transfusion ]
    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.



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Ages Eligible for Study:   2 Months to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02483702


Contacts
Contact: Raj Singhal, MD rsinghal@valley.md
Contact: Vanessa Pohl, BS 6029334482 vpohl@phoenixchildrens.com

Locations
United States, Arizona
Phoenix Children's Hospital Recruiting
Phoenix, Arizona, United States, 85016
Contact: Raj Singhal, MD       rsinghal@valley.md   
Contact: Vanessa Pohl, BS    6029334482    vpohl@phoenixchildrens.com   
Sub-Investigator: Jon Jerman, MD         
Sub-Investigator: Davinder Singh, MD         
Sponsors and Collaborators
Valley Anesthesiology Consultants

Publications:

Responsible Party: Neil Raj Singhal, Director of Research, Valley Anesthesiology Consultants
ClinicalTrials.gov Identifier: NCT02483702     History of Changes
Other Study ID Numbers: 15-063
First Posted: June 29, 2015    Key Record Dates
Last Update Posted: November 3, 2016
Last Verified: November 2016

Keywords provided by Neil Raj Singhal, Valley Anesthesiology Consultants:
Irradiated Blood
Non-Irradiated Blood
graft versus host disease
TA-GVHD
potassium
Blood transfusion

Additional relevant MeSH terms:
Craniosynostoses
Graft vs Host Disease
Congenital Abnormalities
Hyperkalemia
Immune System Diseases
Water-Electrolyte Imbalance
Metabolic Diseases
Synostosis
Dysostoses
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Craniofacial Abnormalities
Musculoskeletal Abnormalities