Allergic Transfusion Reactions in Plasma Transfusion

Risk Factors for Allergic Transfusion Reactions in Patients Receiving Plasma Transfusion

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02200692

Enrollment

Registered

2014-07-25

Start date

2014-06-30

Completion date

2018-03-31

Last updated

2021-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergy, Transfusion Reaction

Keywords

plasma transfusion, allergic transfusion reaction, transfusion reaction, blood transfusion, Solvent detergent plasma

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Patients receiving plasma transfusion

Exclusion criteria

\- Patients not able to complete sampling procedure

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Other

Measure	Time frame
Number of patients with Serious and Non-Serious Adverse Events	Up to 8 weeks after transfusion

Countries

Norway

Outcome results