NCT02200692

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

June 27, 2014

Completed
28 days until next milestone

First Posted

Study publicly available on registry

July 25, 2014

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

June 16, 2021

Status Verified

June 1, 2021

Enrollment Period

3.8 years

First QC Date

June 27, 2014

Last Update Submit

June 15, 2021

Conditions

AllergyTransfusion Reaction

Keywords

plasma transfusionallergic transfusion reactiontransfusion reactionblood transfusionSolvent detergent plasma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change from baseline in basophil reactivity measured by flow cytometry

    Baseline and up to 8 weeks

Other Outcomes (1)

  • Number of patients with Serious and Non-Serious Adverse Events

    Up to 8 weeks after transfusion

Study Arms (1)

plasma transfusion

Patients receiving plasma transfusion.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients receiving plasma transfusion, mainly in relation to cardiac surgery

You may qualify if:

  • Patients receiving plasma transfusion

You may not qualify if:

  • \- Patients not able to complete sampling procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haukeland University Hospital

Bergen, N-5021, Norway

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Samples from patients receiving plasma transfusion and samples from plasma units transfused.

MeSH Terms

Conditions

HypersensitivityTransfusion Reaction

Condition Hierarchy (Ancestors)

Immune System DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Torunn O Apelseth, MD, PhD

    Helse Bergen HF, Haukeland University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2014

First Posted

July 25, 2014

Study Start

June 1, 2014

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

June 16, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)