Status:
COMPLETED
Isoagglutinins in the Development of IVIG-associated Hemolysis
Lead Sponsor:
Toronto Transfusion Medicine Collaborative
Collaborating Sponsors:
University Health Network, Toronto
Sunnybrook Health Sciences Centre
Conditions:
Immunoglobulins, Intravenous
Hemolysis
Eligibility:
All Genders
3+ years
Brief Summary
Patients at high risk of IVIG-associated hemolysis (defined as receipt of a 28-day cumulative dose of ≥ 2 g/kg, adjusted for ideal body weight, and non-O blood group) will be prospectively monitored u...
Detailed Description
All IVIG orders received by the blood transfusion service at participating sites will be screened for patient eligibility. All non-O blood group patients receiving a cumulative 28-day dose of IVIG ≥ 2...
Eligibility Criteria
Inclusion
- cumulative dose within a 28-day period equal or greater to 2 g/kg body weight, adjusted for lean body mass
- non-O blood group
- willing to provide blood samples immediately prior to, immediately after the completion of, and 5-10 days after the course of IVIG therapy
- Able to provide informed consent, either themselves or through a surrogate decision-maker
Exclusion
- evidence of active bleeding or hemolytic anemia at time of enrolment (patients with chronic, stable anemia will be eligible following review by the principle investigator)
- concurrently prescribed transfusion therapy
Key Trial Info
Start Date :
October 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT02259478
Start Date
October 1 2014
End Date
December 1 2016
Last Update
March 14 2017
Active Locations (6)
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1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
2
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
3
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
4
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 2C4