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Transfusion-related EBV Infection Among Allogeneic Stem Cell Transplant Pediatric Recipients (TREASuRE)

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ClinicalTrials.gov Identifier: NCT02505789
Recruitment Status : Unknown
Verified July 2015 by Helen Trottier, St. Justine's Hospital.
Recruitment status was:  Recruiting
First Posted : July 22, 2015
Last Update Posted : July 22, 2015
Sponsor:
Collaborator:
Canadian Blood Services
Information provided by (Responsible Party):
Helen Trottier, St. Justine's Hospital

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.

Condition or disease Intervention/treatment
Lymphoproliferative Disorders Other: Determining the source of EBV in severe EBV infections

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 324 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Transfusion-related Epstein-Barr Virus (EBV) Infection Among Allogeneic Stem Cell Transplant Pediatric Recipients: a Multicenter Prospective Cohort Study (TREASuRE Study)
Study Start Date : May 2013
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : November 2018



Intervention Details:
  • Other: Determining the source of EBV in severe EBV infections
    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.


Primary Outcome Measures :
  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 [ Time Frame: 1 month before transplantation to 1 year post-transplantation ]
    EBV PCR and serology testing every 1-2 weeks until hospital discharge and at follow-up visit thereafter.


Secondary Outcome Measures :
  1. 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 [ Time Frame: 1 month before transplantation to 1 year post-transplantation ]
    Surveillance for PTLD and other EBV complications

  2. 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 [ Time Frame: 1 month before transplantation to 1 year post-transplantation ]
    Surveillance for PTLD and other EBV complications

  3. Description of other complications related to EBV infection in this transplant population [ Time Frame: 1 month before transplantation to 1 year post-transplantation ]
    Surveillance for PTLD and other EBV complications



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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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
Criteria

Inclusion Criteria:

  • patients receiving allogeneic HSCT (marrow, cord-blood, and peripheral blood stem cells)
  • age below 21 years
  • first HSCT

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): NCT02505789


Contacts
Contact: Helen Trottier, PhD 1 514-345-4931 ext 7152 helen.trottier@umontreal.ca
Contact: Lucy Clayton, MSc 1 514-345-4931 ext 6816 lucy.clayton@recherche-ste-justine.qc.ca

Locations
Canada, British Columbia
BC Children's Hospital Recruiting
Vancouver, British Columbia, Canada, V6H 3N1
Contact: Suzanne Vercauteren, MD, PhD, FRCPC    1(604) 875-2000 ext 2939    svercauteren2@cw.bc.ca   
Contact: Michelle Dittrick    1604-875-2345 ext 4679    michelle.dittrick@cw.bc.ca   
Principal Investigator: Suzanne Vercauteren, MD, PhD, FRCPC         
Canada, Manitoba
Cancer Care Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Contact: Geoff Cuvelier, MD, FRCPC    1204-787-8689    geoff.cuvelier@cancercare.mb.ca   
Contact: Kim Shore    1(204) 787-4856    kshore@cancercare.mb.ca   
Principal Investigator: Geoff Cuvelier, MD, FRCPC         
Canada, Quebec
St. Justine's Hospital Recruiting
Montreal, Quebec, Canada, H3T 1C5
Contact: Helen Trottier, PhD    1514 345-4931 ext 7152    helen.trottier@umontreal.ca   
Contact: Lucy Clayton, MSc.    1514 345-4931 ext 6816    lucy.clayton@recherche-ste-justine.qc.ca   
Sub-Investigator: Jacques Lacroix, MD         
Sub-Investigator: Michel Duval, MD         
Sub-Investigator: Marisa Tucci, MD         
Sub-Investigator: Carolina Alfieri, PhD         
Sub-Investigator: Nancy Robitaille, MD         
Sub-Investigator: Chantal Buteau, MD         
Sponsors and Collaborators
St. Justine's Hospital
Canadian Blood Services
Investigators
Principal Investigator: Helen Trottier, PhD St. Justine's Hospital

Publications:
Responsible Party: Helen Trottier, Associate Professor, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT02505789     History of Changes
Other Study ID Numbers: CBS/CIHR_201209-293922
First Posted: July 22, 2015    Key Record Dates
Last Update Posted: July 22, 2015
Last Verified: July 2015

Keywords provided by Helen Trottier, St. Justine's Hospital:
Epstein-Barr Virus
Post-transplant lymphoproliferative disease (PTLD)
Infection
Cell Transplants
Herpesvirus 4, Human

Additional relevant MeSH terms:
Infection
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases