Allergic Transfusion Reactions in Plasma Transfusion

June 15, 2021 updated by: Haukeland University Hospital

Risk Factors for Allergic Transfusion Reactions in Patients Receiving 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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

38

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bergen, Norway, N-5021
        • Haukeland University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients receiving plasma transfusion, mainly in relation to cardiac surgery

Description

Inclusion Criteria:

  • Patients receiving plasma transfusion

Exclusion Criteria:

- Patients not able to complete sampling procedure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
plasma transfusion
Patients receiving plasma transfusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and up to 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and up to 8 weeks

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haukeland University Hospital

Investigators

  • Principal Investigator: Torunn O Apelseth, MD, PhD, Helse Bergen HF, Haukeland University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

June 27, 2014

First Submitted That Met QC Criteria

July 24, 2014

First Posted (Estimate)

July 25, 2014

Study Record Updates

Last Update Posted (Actual)

June 16, 2021

Last Update Submitted That Met QC Criteria

June 15, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014/607
  • REK 2014/607 (Other Identifier: REC West 2014/607)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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