Transfusion-related EBV Infection Among Allogeneic Stem Cell Transplant Pediatric Recipients
TREASuRE
Transfusion-related Epstein-Barr Virus (EBV) Infection Among Allogeneic Stem Cell Transplant Pediatric Recipients: a Multicenter Prospective Cohort Study (TREASuRE Study)
1 other identifier
observational
324
1 country
3
Brief Summary
In many countries, numerous steps are taken to minimize the risk of infection from transfused blood products. Typically, blood banking organisations will screen for an array of infectious pathogens as part of their quality control protocol. While transmission of these tested agents via transfusion has become exceedingly rare, the risk of transfusion-transmitted infections for which testing is not currently performed continues to be a concern. Among these untested infectious agents is Epstein-Barr virus (EBV, also known as human herpesvirus-4). Most notably, infection with this virus in transplant recipients can give rise to a malignant disorder called post-transplant lymphoproliferative disease (PTLD), a life-threatening complication which is due to the uncontrolled expansion of EBV-infected cells. It is also associated with other complications such as hepatitis, hemophagocytic syndrome, etc. in transplant population. It is recognised that EBV infection can occurred in transfused immune suppressed graft recipients but the origin of the viral infection is still a matter of debate. It is a known fact that the EBV already present in the recipient's blood can undergo reactivation due to immune suppression. However, because it is known to occur more frequently in patients who are EBV-seronegative at the time of transplant, it is also accepted that primary infection contracted via an infected graft can be a source of virus. The question we are seeking to answer is whether immune suppressed graft recipients can acquire primary EBV infection via transfusion of blood products. EBV is present in the blood of most adults and cases of EBV transfusion-related infection have been reported. Transplant populations are generally transfused with very large volumes of blood products and our recent pilot study supports the possibility that transfusion-related EBV infection can be transmitted to pediatric hematopoietic stem cell (HSCT) recipients (Trottier et al, 2012). The aim of this study is to analyse the risk of EBV transmission through blood product transfusion in pediatric allogeneic HSCT patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2013
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 15, 2015
CompletedFirst Posted
Study publicly available on registry
July 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2018
CompletedJuly 22, 2015
July 1, 2015
4.5 years
July 15, 2015
July 20, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Measure of the risk of EBV infection in HSCT pediatric recipients from blood products transfusions (red blood cells, platelets, plasma) by EBV PCR and serology testing
EBV PCR and serology testing every 1-2 weeks until hospital discharge and at follow-up visit thereafter.
1 month before transplantation to 1 year post-transplantation
Secondary Outcomes (3)
Incidence of post-transplant EBV infection in allogeneic HSCT pediatric recipients stratified according to the EBV serostatus of the patient and the EBV status of the graft
1 month before transplantation to 1 year post-transplantation
Incidence of "high or increasing viral load EBV infection and PTLD" in allogeneic HSCT pediatric recipients stratified according to the EBV serostatus of the patient and the EBV status of the graft
1 month before transplantation to 1 year post-transplantation
Description of other complications related to EBV infection in this transplant population
1 month before transplantation to 1 year post-transplantation
Interventions
Blood units administered to patients with severe EBV infection will be traced back to the donors who in turn (with consent) will be serologically assessed for EBV, and all seropositive donors will have their EBV strain genotyped for comparison to the patient's strain.
Eligibility Criteria
Only allogeneic HSCTs will be considered (no autologous grafts) because allogeneic grafts require a higher degree of immune suppression, which is known to increase risk with regard to EBV infection, development of PTLD and other EBV complications
You may qualify if:
- patients receiving allogeneic HSCT (marrow, cord-blood, and peripheral blood stem cells)
- age below 21 years
- first HSCT
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- St. Justine's Hospitallead
- Canadian Blood Servicescollaborator
Study Sites (3)
BC Children's Hospital
Vancouver, British Columbia, V6H 3N1, Canada
Cancer Care Manitoba
Winnipeg, Manitoba, R3E 0V9, Canada
St. Justine's Hospital
Montreal, Quebec, H3T 1C5, Canada
Related Publications (2)
Trottier H, Buteau C, Robitaille N, Duval M, Tucci M, Lacroix J, Alfieri C. Transfusion-related Epstein-Barr virus infection among stem cell transplant recipients: a retrospective cohort study in children. Transfusion. 2012 Dec;52(12):2653-63. doi: 10.1111/j.1537-2995.2012.03611.x. Epub 2012 Mar 15.
PMID: 22420319BACKGROUNDAlfieri C, Tanner J, Carpentier L, Perpete C, Savoie A, Paradis K, Delage G, Joncas J. Epstein-Barr virus transmission from a blood donor to an organ transplant recipient with recovery of the same virus strain from the recipient's blood and oropharynx. Blood. 1996 Jan 15;87(2):812-7.
PMID: 8555507BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Helen Trottier, PhD
St. Justine's Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
July 15, 2015
First Posted
July 22, 2015
Study Start
May 1, 2013
Primary Completion
November 1, 2017
Study Completion
November 1, 2018
Last Updated
July 22, 2015
Record last verified: 2015-07