Recruiting

Observational Study

Sponsor:

St. Justine's Hospital

Code:

NCT02505789

Conditions

Lymphoproliferative Disorders

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

Interventions

Determining the source of EBV in severe EBV infections

Study Details

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.

Conditions

Lymphoproliferative Disorders

Study ID

NCT02505789

Start date

May, 2013

Status verified date

Jul, 2015

Completion date

Nov, 2018

Anticipated

Primary completion date

Nov, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Design

Enrollment

324 participants

Anticipated

Interventions and Outcome Measures

Interventions

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 measure

  • 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 ]

Central Contacts and Locations

Locations

BC Children's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6H 3N1

Contacts

Suzanne Vercauteren, MD, PhD, FRCPC

1(604) 875-2000svercauteren2@cw.bc.ca

Principal Investigator:

Suzanne Vercauteren, MD, PhD, FRCPC

Cancer Care Manitoba

Recruiting

Winnipeg, Manitoba, Canada, R3E 0V9

Contacts

Principal Investigator:

Geoff Cuvelier, MD, FRCPC

St. Justine's Hospital

Recruiting

Montreal, Quebec, Canada, H3T 1C5

Contacts

More Information

Sponsor

St. Justine's Hospital

Last update posted

Jul 22, 2015

Last verified

Jul, 2015

Keywords

  • Epstein-Barr Virus
  • Post-transplant lymphoproliferative disease (PTLD)
  • Infection
  • Cell Transplants
  • Herpesvirus 4, Human

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Justine's Hospital on 2015-07-22.