Allergic Transfusion Reactions in Plasma Transfusion

Completed

• Conditions: Allergy; Transfusion Reaction

• Registration Number: NCT02200692
• Lead Sponsor: Haukeland University Hospital

Brief Summary

Allergic transfusion reactions are a common complication of transfusion by blood components containing plasma. This study aims to investigate passive transfer of Immunoglobin E antibodies as a risk factor of allergic reactions to plasma transfusion by use of Solvent Detergent plasma.

Detailed Description

Prospective observation study, aiming to measure transfer of Immunoglobin E antibodies and other factors associated with allergic complications in patients receiving plasma transfusion. Samples from patients and plasma units will be investigated. Samples frozen until investigation. To assess biological relevance of findings, additional analysis of basophil reactivity will be performed and information on clinical allergy collected by use of a questionaire .

In-patients will be recruited if receiving plasma transfusion during surgery or if an allergic transfusion complication occurs.

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-27
• Study First Submitted QC: 2014-07-24
• Study First Posted: 2014-07-25
• Primary Completion: 2018-03
• Study Completion: 2018-03
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-15
• Last Update Posted: 2021-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• Patients receiving plasma transfusion

Exclusion Criteria

• Patients not able to complete sampling procedure

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in concentration of allergen specific Immunoglobin E antibodies	Baseline and up to 8 weeks	Multiple measurements over time needed to describe clearance of antibodies. Baseline samples defined as sample drawn less than 7 days before transfusion. After transfusion samples will be investigated daily during hospital stay (anticipated up to 14 days), and 4, 6 and/or 8 weeks after transfusion.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in basophil reactivity measured by flow cytometry	Baseline and up to 8 weeks	Multiple measurements over time needed to describe clearance of antibodies. Baseline samples defined as sample drawn less than 7 days before transfusion. After transfusion samples will be investigated during hospital stay, and 4, 6 and/or 8 weeks after transfusion.

Trial Locations

Locations (1)

Haukeland University Hospital; 🇳🇴 Bergen, Norway