Isoagglutinins in the Development of IVIG-associated Hemolysis

NCT02259478 | Completed

• 1 other identifier: 14-8191-CE
• Study Type: observational
• Target: 144
• Locations: 1 country
• Sites: 6

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 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

Keywords

Intravenous Immunoglobulin (IVIG); Hemolysis; Transfusion Medicine; Pharmacovigilance

Outcome Measures

Primary Outcomes (1)

• Hemolysis

  Definition and grading of hemolysis adopted from the Canadian IVIG Hemolysis Pharmacovigilance Group

  From initiation of IVIG therapy to 5-10 days after the completion of last IVIG infusion

Secondary Outcomes (2)

• Adverse transfusion reaction

  From initiation of IVIG therapy to 5-10 days after the completion of last IVIG infusion

• Descriptive analysis of risk factors

  From initiation of IVIG therapy to 5-10 days after the completion of last IVIG infusion

Eligibility Criteria

• Age: 3 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All orders for IVIG received by the UHN Blood Transfusion Service will be reviewed by the study coordinator to identify potential study participants

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Toronto Transfusion Medicine Collaborative: lead
• University Health Network, Toronto: collaborator
• Sunnybrook Health Sciences Centre: collaborator
• Mount Sinai Hospital, New York: collaborator
• The Hospital for Sick Children: collaborator
• Unity Health Toronto: collaborator
• Women's College Hospital: collaborator

Study Sites (6)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Women's College Hospital

Toronto, Ontario, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood samples will be collected immediately prior and following a course of IVIG therapy, and then again 5-10 days later

MeSH Terms

Conditions

Hemolysis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Don Branch, PhD

  Canadian Blood Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant in Transfusion Medicine

Study Record Dates

• First Submitted: August 29, 2014
• First Posted: October 8, 2014
• Study Start: October 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 14, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share

Locations

CA (6)