Babesioses, HumanNCT06462677
Surveillance of Emerging Pathogens to Ensure Blood Supply Safety
An observational study of Babesioses, Human, run by Canadian Blood Services.
Trial summary
Babesia is a parasite that can be transmitted from the bite of a tick to an individual. While many some people may not have any symptoms from infection, others may experience anything from flu-like symptoms to joint pain, hemolytic anemia, or jaundice. Read more about this study
- Who is it for?
- Ages 17 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Babesioses, Human
- What is being tested?
- Babesia NAT
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 2 Oct 2024to 27 Oct 2024
- Phase
- Observational
- 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 17 to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Only blood donors will be included in this study. Minimum age for whole blood donation is 17 years and there is no maximum age limit. Eligibility for donation requires donors to be healthy at time of collection.
Who may be able to join
- all whole blood donors giving blood in Manitoba during the study period
Who cannot join
- individuals not eligible to donate blood
About this study
Babesia is a parasite that can be transmitted from the bite of a tick to an individual. While many some people may not have any symptoms from infection, others may experience anything from flu-like symptoms to joint pain, hemolytic anemia, or jaundice. Should an infected individual donate blood, they could pass the infection to a recipient through their blood donation. In 2018, Canadian Blood Services (CBS) screened blood donations between June and October, and Babesia was found in 0.002% - 0.0007% of donors. This prevalence is slightly less than other areas where Babesia testing is not mandated for blood donors (such as Arizona and Oklahoma), and several logs less than areas where Babesia testing is mandated for blood donations. Based on these data, a later Canadian Babesia case, and risk modelling by CBS, a risk-based decision-making (RBDM) process was initiated. The RBDM strongly emphasizes consistent monitoring and frequent testing for Babesia among Canadian blood donors. This proactive strategy is aimed at minimizing the risk of Babesia transmission through donated blood. This study will span five years and examine the prevalence of Babesia, other tick-borne diseases (such as Anaplasma and Powassan virus), and other emerging pathogens which may impact the blood supply.
Read the detailed description
Overview: This multi-year study will span five years and will examine the prevalence of tick-borne and emerging pathogens that may impact the safety of the blood supply. An overview of the timeline of the study is attached as Figure 1. This study will have a direct impact on the screening of blood donations for infectious disease and will be used to implement evidence-based policy decisions for screening recommendations.
Blood donation: Whole blood donors donating blood in the identified geographic regions will arrive at the Donation Center as routine. When they arrive, they will be asked to read: (1) "What happens to your donation" pamphlet , which describes that "parts of your donation may be used… for quality assurance purposes, evaluating the blood supply process and product improvement testing;" (2) "What you must know to donate blood" pamphlet , which indicates that "other tests may be done on some donations as required", and that "you will be informed of unusual results from any of the tests that we perform;" and (3) the "Privacy Notice to Blood Donors, Stem Cell Registry Participants and for Canadian Blood Services' Cord Blood Bank" (routine). Only donors who are donating blood as part of their routine self-driven blood donation will be included in the study, participants will not be contacted to come in for blood donation for the purposes of this study. Samples will be collected as part of a normal blood donation. A diversion pouch is routinely collected during each donation. Retention samples (routine) and lysis tubes (study) will be filled on-site at collections from the diversion pouch. Priority will be given to all routine collections from the diversion pouch prior to lysis tube collection. No additional volume will be collected from donors for this study.
Routine Testing: All pre-release testing will be completed as normal, and products will be released into inventory prior to any study testing. Testing performed as part of this surveillance project (Babesia, Anaplasma, etc.) are not considered release tests, and therefore will not affect the available blood supply, nor delay release of any blood products.
Study Testing: Following collection of retention sample and lysis tube, samples will be sent to Ottawa lab for labelling and storage. Samples will be batch tested either in-house with CBS, or by the American Red Cross (ARC). Confirmatory testing or other specialized testing for positive samples may be performed at the National Microbiology Laboratory. Lysis samples will be stored up to one year from time of collection, and residual samples will be stored up to 5 years from time of collection for all samples collected as part of this study to allow for additional markers to be tested as needed..
Result Reporting: All positive results will be communicated to the donor via the CBS Medical Office (letter) and by the CBS Medical Officer (phone call) to explain risk factor data and notify of indefinite deferral. Provincial MOHs will be notified of positive results in accordance with provincial communicable disease reporting. If a positive is found, transfusable components associated with that donation will be recalled.
Data Access and Data Analysis: Data will be uploaded to CBS Data Storage and linked with the donation number. Donation number is not identifiable outside of access to CBS eProgesa. Epidemiology and Surveillance Team will link data on secure CBS server (data stored only on servers and database systems, not on laptops). All data will be retrieved from CBS records and merged with the surveillance testing data. Aggregate non-identifiable data will be presented and published for knowledge translation. Study data will be shared in the Surveillance Report and ongoing study information will be added to the website. Data will be stored for 10 years and will be used to affect evidence-based policy decisions on emerging pathogens in the Canadian blood supply.
- Conditions
- Babesioses, Human
- Being tested
- Babesia NAT
- Medical subject headings
- Babesiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Babesia NATDiagnostic test
Blood donors will be tested with Babesia NAT
| Study group | Role | What they receive |
|---|---|---|
| Manitoba whole blood donors | All whole blood donors giving blood in Manitoba will be collected for Babesia NAT testing to understand the prevalence of babesiosis in the Canadian province of Manitoba Receives: Diagnostic Test: Babesia NAT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Babesia in Canadian Blood Donors
All whole blood donors in Manitoba will be tested for Babesia
Measured: Anticipated July 2 2024 to Oct 25 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start2 Oct 2024
- Primary completion26 Oct 2024
- Study completion27 Oct 2024
Why it stopped: The kits were FDA and Health Canada approved and therefore the clinical trial is no longer needed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Babesioses, HumanStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canadian Blood Services
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mindy Goldman, Canadian Blood Services
- Investigators
- Carmen L Charlton, PhD, Study chair, Canadian Blood ServicesSteven Drews, PhD, Study director, Microbiology, Donation Policy And Studies, Canadian Blood ServicesMindy Goldman, MD, Principal investigator, Canadian Blood Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06462677
- Sponsor's protocol ID
- Version 02
- Status last verified
- Aug 2025
- First submitted
- 12 Jun 2024
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only aggregate data will be shared, individual data will not be shared with outside researchers
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surveillance of Emerging Pathogens to Ensure Blood Supply Safety
- ClinicalTrials.gov ID
- NCT06462677
- Acronym / sponsor ID
- Version 02
- Conditions
- Babesioses, Human
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The kits were FDA and Health Canada approved and therefore the clinical trial is no longer needed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Canadian Blood ServicesUniversity, hospital or other
- Study start
- 2 Oct 2024 (actual)
- Primary completion
- 26 Oct 2024 (actual)
- Study completion
- 27 Oct 2024 (actual)
- First posted
- 17 Jun 2024 (actual)
- 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.
Babesia is a parasite that can be transmitted from the bite of a tick to an individual. While many some people may not have any symptoms from infection, others may experience anything from flu-like symptoms to joint pain, hemolytic anemia, or jaundice. Should an infected individual donate blood, they could pass the infection to a recipient through their blood donation. In 2018, Canadian Blood Services (CBS) screened blood donations between June and October, and Babesia was found in 0.002% - 0.0007% of donors. This prevalence is slightly less than other areas where Babesia testing is not mandated for blood donors (such as Arizona and Oklahoma), and several logs less than areas where Babesia testing is mandated for blood donations. Based on these data, a later Canadian Babesia case, and risk modelling by CBS, a risk-based decision-making (RBDM) process was initiated. The RBDM strongly emphasizes consistent monitoring and frequent testing for Babesia among Canadian blood donors. This proactive strategy is aimed at minimizing the risk of Babesia transmission through donated blood. This study will span five years and examine the prevalence of Babesia, other tick-borne diseases (such as Anaplasma and Powassan virus), and other emerging pathogens which may impact the blood supply.
Detailed description
Overview: This multi-year study will span five years and will examine the prevalence of tick-borne and emerging pathogens that may impact the safety of the blood supply. An overview of the timeline of the study is attached as Figure 1. This study will have a direct impact on the screening of blood donations for infectious disease and will be used to implement evidence-based policy decisions for screening recommendations.
Blood donation: Whole blood donors donating blood in the identified geographic regions will arrive at the Donation Center as routine. When they arrive, they will be asked to read: (1) "What happens to your donation" pamphlet , which describes that "parts of your donation may be used… for quality assurance purposes, evaluating the blood supply process and product improvement testing;" (2) "What you must know to donate blood" pamphlet , which indicates that "other tests may be done on some donations as required", and that "you will be informed of unusual results from any of the tests that we perform;" and (3) the "Privacy Notice to Blood Donors, Stem Cell Registry Participants and for Canadian Blood Services' Cord Blood Bank" (routine). Only donors who are donating blood as part of their routine self-driven blood donation will be included in the study, participants will not be contacted to come in for blood donation for the purposes of this study. Samples will be collected as part of a normal blood donation. A diversion pouch is routinely collected during each donation. Retention samples (routine) and lysis tubes (study) will be filled on-site at collections from the diversion pouch. Priority will be given to all routine collections from the diversion pouch prior to lysis tube collection. No additional volume will be collected from donors for this study.
Routine Testing: All pre-release testing will be completed as normal, and products will be released into inventory prior to any study testing. Testing performed as part of this surveillance project (Babesia, Anaplasma, etc.) are not considered release tests, and therefore will not affect the available blood supply, nor delay release of any blood products.
Study Testing: Following collection of retention sample and lysis tube, samples will be sent to Ottawa lab for labelling and storage. Samples will be batch tested either in-house with CBS, or by the American Red Cross (ARC). Confirmatory testing or other specialized testing for positive samples may be performed at the National Microbiology Laboratory. Lysis samples will be stored up to one year from time of collection, and residual samples will be stored up to 5 years from time of collection for all samples collected as part of this study to allow for additional markers to be tested as needed..
Result Reporting: All positive results will be communicated to the donor via the CBS Medical Office (letter) and by the CBS Medical Officer (phone call) to explain risk factor data and notify of indefinite deferral. Provincial MOHs will be notified of positive results in accordance with provincial communicable disease reporting. If a positive is found, transfusable components associated with that donation will be recalled.
Data Access and Data Analysis: Data will be uploaded to CBS Data Storage and linked with the donation number. Donation number is not identifiable outside of access to CBS eProgesa. Epidemiology and Surveillance Team will link data on secure CBS server (data stored only on servers and database systems, not on laptops). All data will be retrieved from CBS records and merged with the surveillance testing data. Aggregate non-identifiable data will be presented and published for knowledge translation. Study data will be shared in the Surveillance Report and ongoing study information will be added to the website. Data will be stored for 10 years and will be used to affect evidence-based policy decisions on emerging pathogens in the Canadian blood supply.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Manitoba whole blood donors | – | Diagnostic Test: Babesia NATAll whole blood donors giving blood in Manitoba will be collected for Babesia NAT testing to understand the prevalence of babesiosis in the Canadian province of Manitoba |
Who may qualify
- Ages
- 17 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Only blood donors will be included in this study. Minimum age for whole blood donation is 17 years and there is no maximum age limit. Eligibility for donation requires donors to be healthy at time of collection.
Key inclusion criteria (1 listed)
- all whole blood donors giving blood in Manitoba during the study period
Key exclusion criteria (1 listed)
- individuals not eligible to donate blood
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 |
|---|---|---|
| Babesia NATBlood donors will be tested with Babesia NAT | Diagnostic test | Manitoba whole blood donors |
Primary outcome
Prevalence of Babesia in Canadian Blood Donors
Time frame: Anticipated July 2 2024 to Oct 25 2024
All whole blood donors in Manitoba will be tested for Babesia
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Individual participant dataSharing planned: No. Only aggregate data will be shared, individual data will not be shared with outside researchers
Related trials for Babesioses, Human
RecruitingObservational study
FINtick - a Prospective Multicenter Study on Tick-borne Infections in Finland
Tick Borne Encephalitis (TBE), Lyme Borreliosis
RecruitingObservational study
Human Babesiosis in Metropolitan France
Human Babesiosis
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.
Carmen L Charlton, PhD study chair
Canadian Blood Services
Steven Drews, PhD study director
Microbiology, Donation Policy And Studies, Canadian Blood Services
Mindy Goldman, MD principal investigator
Canadian Blood Services
Questions about this trial
What is this clinical trial studying?
An observational study of Babesioses, Human, run by Canadian Blood Services.
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 1 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: withdrawn, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Prevalence of Babesia in Canadian Blood Donors (time frame: Anticipated July 2 2024 to Oct 25 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2025.