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Completed

NCT Number: NCT02200692

Allergic Transfusion Reactions in Plasma Transfusion

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.

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Key information

Conditions

Allergy Hematologic Diseases Hemic and Lymphatic Diseases Hypersensitivity Immune System Diseases Transfusion Reaction

Sex eligibility

All sexes

Study type

Observational

Primary location

Haukeland University Hospital

Bergen, N-5021, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients receiving plasma transfusion

Exclusion criteria

  • Patients not able to complete sampling procedure

Treatment and study plan

Primary outcomes

  1. Change from baseline in concentration of allergen specific Immunoglobin E antibodies

    Time frame: 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 outcomes

  1. Change from baseline in basophil reactivity measured by flow cytometry

    Time frame: 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.

Other outcomes

  1. Number of patients with Serious and Non-Serious Adverse Events

    Time frame: Up to 8 weeks after transfusion

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Registry information

Official study title

Risk Factors for Allergic Transfusion Reactions in Patients Receiving Plasma Transfusion

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jul 25, 2014
Registry last updated
Jun 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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