AllergyNCT02200692
Allergic Transfusion Reactions in Plasma Transfusion
An observational study of Allergy and Transfusion Reaction, run by Haukeland University Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Allergy, Transfusion Reaction
- How many people
- 38 participants
- Where
- 1 siteNorway
- Study dates
- Jun 2014to Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients receiving plasma transfusion, mainly in relation to cardiac surgery
Who may be able to join
- Patients receiving plasma transfusion
Who cannot join
- Patients not able to complete sampling procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Allergy, Transfusion Reaction
- Keywords
- plasma transfusion, allergic transfusion reaction, transfusion reaction, blood transfusion, Solvent detergent plasma
- Medical subject headings
- Hypersensitivity, Transfusion Reaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| plasma transfusion | Patients receiving plasma transfusion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and up to 8 weeks
Secondary outcomes (1)
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.
Measured: Baseline and up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Torunn O Apelseth, MD, PhD, Principal investigator, Helse Bergen HF, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02200692
- Sponsor's protocol ID
- 2014/607
- Other IDs
- REK 2014/607
- Status last verified
- Jun 2021
- First submitted
- 27 Jun 2014
- Last updated
- 16 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Allergic Transfusion Reactions in Patients Receiving Plasma Transfusion
- ClinicalTrials.gov ID
- NCT02200692
- Acronym / sponsor ID
- 2014/607
- Conditions
- Allergy, Transfusion Reaction
- Keywords
- plasma transfusion, allergic transfusion reaction, transfusion reaction, blood transfusion, Solvent detergent plasma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 25 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| plasma transfusion | – | –Patients receiving plasma transfusion. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients receiving plasma transfusion, mainly in relation to cardiac surgery
Key inclusion criteria (1 listed)
- Patients receiving plasma transfusion
Key exclusion criteria (1 listed)
- Patients not able to complete sampling procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Change from baseline in basophil reactivity measured by flow cytometry
Time frame: Baseline and up to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Torunn O Apelseth, MD, PhD principal investigator
Helse Bergen HF, Haukeland University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergy and Transfusion Reaction, run by Haukeland University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in concentration of allergen specific Immunoglobin E antibodies (time frame: Baseline and up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2021.