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Isoagglutinins in the Development of IVIG-associated Hemolysis

NCT02259478 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 144

Last updated 2017-03-14

No results posted yet for this study

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 using a standardized protocol for signs of hemolysis, and will be undergo additional testing for variables that have been hypothesized to increase the risk of hemolysis. The goal of the study is to define the incidence and dynamics of IVIG-mediated hemolysis and identify patient and product-related factors that may predict which patients are especially at risk.

Conditions

  • Immunoglobulins, Intravenous
  • Hemolysis

Sponsors & Collaborators

  • University Health Network, Toronto

    collaborator OTHER

  • Sunnybrook Health Sciences Centre

    collaborator OTHER

  • Mount Sinai Hospital, New York

    collaborator OTHER

  • The Hospital for Sick Children

    collaborator OTHER

  • Unity Health Toronto

    collaborator OTHER

  • Women's College Hospital

    collaborator OTHER

  • Toronto Transfusion Medicine Collaborative

    lead OTHER

Principal Investigators

  • Don Branch, PhD · Canadian Blood Services

Eligibility

Min Age
3 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2016-10-31
Completion
2016-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02259478 on ClinicalTrials.gov