Allergic Transfusion Reactions in Plasma Transfusion

Allergy Clinical Trial

Official title:

Risk Factors for Allergic Transfusion Reactions in Patients Receiving Plasma Transfusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02200692
• Other study ID #: 2014/607
• Secondary ID: REK 2014/607
• Status: Completed
• Start date: June 2014
• Est. completion date: March 2018

Study information

• Verified date: June 2021
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients receiving plasma transfusion

Exclusion Criteria:

• Patients not able to complete sampling procedure

Related Conditions & MeSH terms

• Allergy
• Transfusion Reaction

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen

Sponsors (1)

Lead Sponsor	Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of patients with Serious and Non-Serious Adverse Events		Up to 8 weeks after transfusion
Primary	Change from baseline in concentration of allergen specific Immunoglobin E antibodies	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.	Baseline and up to 8 weeks
Secondary	Change from baseline in basophil reactivity measured by flow cytometry	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.	Baseline and up to 8 weeks