Overview

This trial is active, not recruiting.

Conditions allergy, transfusion reaction
Sponsor Haukeland University Hospital
Start date June 2014
End date March 2016
Trial size 20 participants
Trial identifier NCT02200692, 2014/607, REK 2014/607

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Patients receiving plasma transfusion.

Primary Outcomes

Measure
Change from baseline in concentration of allergen specific Immunoglobin E antibodies
time frame: Baseline and up to 8 weeks

Secondary Outcomes

Measure
Change from baseline in basophil reactivity measured by flow cytometry
time frame: Baseline and up to 8 weeks

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Patients receiving plasma transfusion Exclusion Criteria: - Patients not able to complete sampling procedure

Additional Information

Official title Risk Factors for Allergic Transfusion Reactions in Patients Receiving Plasma Transfusion
Principal investigator Torunn O Apelseth, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Haukeland University Hospital.