Graft Versus Host DiseaseNCT02483702
Irradiated Blood Versus Non Irradiated Blood Transfusions in Craniosynostosis Repair
A study testing Irradiated Blood Transfusions and Non-Irradiated Blood Transfusions in people with Graft Versus Host Disease and Hyperkalemia, run by Valley Anesthesiology Consultants at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 2 to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Graft Versus Host Disease, Hyperkalemia, Craniectomy
- What is being tested?
- Irradiated Blood Transfusions and Non-Irradiated Blood Transfusions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to 11 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Must be between 2-6 m/o
- Must be undergoing a craniosynostosis repair
- Must require a blood transfusion
Who cannot join
- n/a
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Affect of Radiated Versus Non-Irradiated Blood on Extracellular Potassium Levels in Infants Undergoing Craniosynostosis Repair
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.
Read the 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.
- Conditions
- Graft Versus Host Disease, Hyperkalemia, Craniectomy, Synostectomy, FOA, Congenital Malformations
- Being tested
- Irradiated Blood Transfusions, Non-Irradiated Blood Transfusions
- Keywords
- Irradiated Blood, Non-Irradiated Blood, graft versus host disease, TA-GVHD, potassium, Blood transfusion
- Medical subject headings
- Graft vs Host Disease, Hyperkalemia, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Non-Irradiated Blood Transfusions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: immediately after transfusion and 30 minutes after the end of transfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2015 (estimated)
- Study startAug 2015
- Primary completion11 May 2017
- Study completion11 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Graft Versus Host DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valley Anesthesiology Consultants
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neil Raj Singhal, Valley Anesthesiology Consultants
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02483702
- Sponsor's protocol ID
- 15-063
- Status last verified
- Oct 2018
- First submitted
- 22 Jun 2015
- Last updated
- 19 Oct 2018
- Results posted
- No
- Individual data sharing
- No
Publications
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.
PubMed 21404983Rosen 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.
PubMed 8430450Schroeder 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.
PubMed 11972509Lee 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.
PubMed 23581425Bontadini 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.
PubMed 12100387Weiskopf 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.
PubMed 16078915Olson 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.
PubMed 23690124Vraets 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.
PubMed 21498041Faberowski 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.
PubMed 10414670
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Affect of Radiated Versus Non-Irradiated Blood on Extracellular Potassium Levels in Infants Undergoing Craniosynostosis Repair
- ClinicalTrials.gov ID
- NCT02483702
- Acronym / sponsor ID
- 15-063
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Valley Anesthesiology ConsultantsUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- 11 May 2017 (actual)
- Study completion
- 11 May 2017 (actual)
- First posted
- 29 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients under 4 months Receive Irradiated Blood | Experimental | Other: Irradiated Blood TransfusionsPatients 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 Recieve Non-Irradiated Blood | Experimental | Other: Non-Irradiated Blood TransfusionsPatients 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. |
Who may qualify
- Ages
- 2 to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Must be between 2-6 m/o
- Must be undergoing a craniosynostosis repair
- Must require a blood transfusion
Key exclusion criteria (1 listed)
- n/a
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Irradiated Blood TransfusionsSame as arm description - need to collect extracellular potassium values. | Other | Patients under 4 months Receive Irradiated Blood |
| Non-Irradiated Blood TransfusionsSame as arm description - need to collect extracellular potassium values. | Other | Patients Over 4 Months Recieve Non-Irradiated Blood |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2018.
- Background: PubMed 21404983Sharma S, Sharma P, Tyler LN. Transfusion of blood and blood products: indications and complications. Am Fam Physician. 2011 Mar 15;83(6):719-24.
- Background: PubMed 8430450Rosen 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.
- Background: PubMed 11972509Schroeder 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.
- Background: PubMed 23581425Lee 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.
- Background: PubMed 12100387Bontadini 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.
- Background: PubMed 16078915Weiskopf 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.
- Background: PubMed 23690124Olson 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.
- Background: PubMed 21498041Vraets 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.
- Background: PubMed 10414670Faberowski 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Irradiated Blood Transfusions and Non-Irradiated Blood Transfusions in people with Graft Versus Host Disease and Hyperkalemia, run by Valley Anesthesiology Consultants at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in extracellular potassium values. (time frame: immediately after transfusion and 30 minutes after the end of transfusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02483702, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2018.