Surveillance of Emerging Pathogens to Ensure Blood Supply Safety

NCT06462677 | Withdrawn

• 1 other identifier: Version 02
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Babesioses, Human

Outcome Measures

Primary Outcomes (1)

• Prevalence of Babesia in Canadian Blood Donors

  All whole blood donors in Manitoba will be tested for Babesia

  Anticipated July 2 2024 to Oct 25 2024

Study Arms (1)

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

Diagnostic Test: Babesia NAT

Interventions

Babesia NAT DIAGNOSTIC_TEST

Blood donors will be tested with Babesia NAT

Manitoba whole blood donors

Eligibility Criteria

• Age: 17 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• all whole blood donors giving blood in Manitoba during the study period

You may not qualify if:

• individuals not eligible to donate blood

Sponsors & Collaborators

• Canadian Blood Services: lead

Biospecimen

Retention: SAMPLES WITH DNA

Samples will be collected from the diversion pouch during blood donation and added to a lysis tube which will be used to test for the present of Babesia nucleic acid.

MeSH Terms

Conditions

Babesiosis

Condition Hierarchy (Ancestors)

Protozoan Infections, Animal; Parasitic Diseases, Animal; Parasitic Diseases; Infections; Protozoan Infections; Tick-Borne Diseases; Vector Borne Diseases; Animal Diseases

Study Officials

• Carmen L Charlton, PhD

  Canadian Blood Services

  STUDY CHAIR

• Steven Drews, PhD

  Microbiology, Donation Policy And Studies, Canadian Blood Services

  STUDY DIRECTOR

• Mindy Goldman, MD

  Canadian Blood Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director - Donation Policy and Studies

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 17, 2024
• Study Start: October 2, 2024
• Primary Completion: October 26, 2024
• Study Completion: October 27, 2024
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share