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| ID | Type | Description | Link |
|---|---|---|---|
| REK 2014/607 | Other Identifier | REC West 2014/607 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| plasma transfusion | Patients receiving plasma transfusion. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with Serious and Non-Serious Adverse Events | Up to 8 weeks after transfusion |
Inclusion Criteria:
Exclusion Criteria:
- Patients not able to complete sampling procedure
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Patients receiving plasma transfusion, mainly in relation to cardiac surgery
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| Name | Affiliation | Role |
|---|---|---|
| Torunn O Apelseth, MD, PhD | Helse Bergen HF, Haukeland University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haukeland University Hospital | Bergen | N-5021 | Norway |
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| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| D065227 | Transfusion Reaction |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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Samples from patients receiving plasma transfusion and samples from plasma units transfused.