Adverse Effects in the Therapeutic Use of Plasma SubstitutesNCT02007473
A Prospective Non-interventional Study to Evaluate the Safety of Methylene Blue Plasma
An observational study of Adverse Effects in the Therapeutic Use of Plasma Substitutes, run by Maco Productions S.A.S. at 4 sites in 4 countries.
Trial summary
The objective of this non-interventional study is to gather data on adverse reactions occurring with Methylene Blue plasma administered in a routine clinical practice environment; to know more about their characteristics and behaviour and the possible factors that may influence their presentation and evolution. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Adverse Effects in the Therapeutic Use of Plasma Substitutes
- How many people
- 8 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Jul 2013to May 2015
- 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: Inpatients requiring plasma transfusion
Who may be able to join
- Patients, who have received a transfusion with Methylene Blue plasma produced using the THERAFLEX MB-Plasma procedure from MacoPharma and experience an adverse reaction.
Who cannot join
- Patients receiving transfusion with other plasma types during the same transfusion episode
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Spain1 site
Complexo Hospitalario Universitario
Santiago de Compostela, La Coruña, 15706
United Kingdom1 site
University Hospitals of Leicester NHS Trust
Leicester, LE1 5WW
About this study
The objective of this non-interventional study is to gather data on adverse reactions occurring with Methylene Blue plasma administered in a routine clinical practice environment; to know more about their characteristics and behaviour and the possible factors that may influence their presentation and evolution.
Read the detailed description
This is an open label, multi-centre, non-controlled, non-randomized, non-interventional study to evaluate the safety of Methylene Blue (MB) plasma. One centre per country will participate from United Kingdom, Belgium, Greece and Spain.
The haemovigilance Case Report Form (CRF) will be completed for all patients who receive a Methylene Blue plasma transfusion and experience an adverse reaction. The patients will be monitored for the occurrence of possible adverse reactions within 24 hours after start of the transfusion. If the patient experiences an adverse reaction, information about the adverse reaction will be documented. Serious adverse reactions will be collected within a 7-day period after the transfusion.
Each adverse reaction or serious adverse reaction will be followed up for 28 days after the occurrence of the reaction.
Each centre will provide the number of transfused Methylene Blue plasma units and the number of transfused Methylene Blue plasma patients every three months.
Information collected on the haemovigilance CRF will include:
- Details about the transfusion (transfused units, volume, other non-plasma blood components transfused)
- Details about the plasma (collected from whole blood, aphaeresis or both, filter using, type of reference used, illumination device model)
- Demographic data
- Transfusion history (including hospital department)
- History of previous transfusion reactions
- Details about the adverse reaction (date and time of reaction)
- Signs and symptoms and allocation to a diagnosis
- Classification of the adverse reaction (severity, imputability, non-serious or serious)
- Actions taken
- Outcome
- Time to recovery
- Keywords
- Haemovigilance, Plasma, Pathogen reduction, Methylene Blue
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 |
|---|---|---|
| Patients requiring transfusion with plasma | Recipients, who have received a transfusion with Methylene Blue plasma produced using the THERAFLEX MB-Plasma procedure from MacoPharma. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of transfusion reactions following administration of Methylene Blue Plasma based on the total number of transfusions administered
Measured: One year
Secondary outcomes (1)
The incidence of specific transfusion reactions following administration of Methylene Blue plasma
The rate of the different type of adverse events registered along the time frame.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2013 (estimated)
- Study startJul 2013
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse Effects in the Therapeutic Use of Plasma SubstitutesStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maco Productions S.A.S.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SynteractHCR
- Responsible party
- Sponsor
- Investigators
- Hafiz Qureshi, MD, PhD, Principal investigator, University Hospitals, LeicesterMercedes Villamayor, MD, PhD, Principal investigator, Complejo Hospitalario Universitario de SantiagoLucien Noens, MD PhD, Principal investigator, University GhentAggeliki Megalou, MD PhD, Principal investigator, G. H. A. Evaggelismos, Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02007473
- Sponsor's protocol ID
- 1974/MCP
- Status last verified
- Sep 2015
- First submitted
- 29 Nov 2013
- Last updated
- 9 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Non-interventional Study to Evaluate the Safety of Methylene Blue Plasma
- ClinicalTrials.gov ID
- NCT02007473
- Acronym / sponsor ID
- 1974/MCP
- Keywords
- Haemovigilance, Plasma, Pathogen reduction, Methylene Blue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Maco Productions S.A.S.Industry (pharma, biotech, devices)
- Collaborators
- SynteractHCR
- Study start
- Jul 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 10 Dec 2013 (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.
The objective of this non-interventional study is to gather data on adverse reactions occurring with Methylene Blue plasma administered in a routine clinical practice environment; to know more about their characteristics and behaviour and the possible factors that may influence their presentation and evolution.
Detailed description
This is an open label, multi-centre, non-controlled, non-randomized, non-interventional study to evaluate the safety of Methylene Blue (MB) plasma. One centre per country will participate from United Kingdom, Belgium, Greece and Spain.
The haemovigilance Case Report Form (CRF) will be completed for all patients who receive a Methylene Blue plasma transfusion and experience an adverse reaction. The patients will be monitored for the occurrence of possible adverse reactions within 24 hours after start of the transfusion. If the patient experiences an adverse reaction, information about the adverse reaction will be documented. Serious adverse reactions will be collected within a 7-day period after the transfusion.
Each adverse reaction or serious adverse reaction will be followed up for 28 days after the occurrence of the reaction.
Each centre will provide the number of transfused Methylene Blue plasma units and the number of transfused Methylene Blue plasma patients every three months.
Information collected on the haemovigilance CRF will include:
- Details about the transfusion (transfused units, volume, other non-plasma blood components transfused)
- Details about the plasma (collected from whole blood, aphaeresis or both, filter using, type of reference used, illumination device model)
- Demographic data
- Transfusion history (including hospital department)
- History of previous transfusion reactions
- Details about the adverse reaction (date and time of reaction)
- Signs and symptoms and allocation to a diagnosis
- Classification of the adverse reaction (severity, imputability, non-serious or serious)
- Actions taken
- Outcome
- Time to recovery
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients requiring transfusion with plasma | – | –Recipients, who have received a transfusion with Methylene Blue plasma produced using the THERAFLEX MB-Plasma procedure from MacoPharma. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Inpatients requiring plasma transfusion
Key inclusion criteria (1 listed)
- Patients, who have received a transfusion with Methylene Blue plasma produced using the THERAFLEX MB-Plasma procedure from MacoPharma and experience an adverse reaction.
Key exclusion criteria (1 listed)
- Patients receiving transfusion with other plasma types during the same transfusion episode
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
The incidence of transfusion reactions following administration of Methylene Blue Plasma based on the total number of transfusions administered
Time frame: One year
1 secondary outcome
The incidence of specific transfusion reactions following administration of Methylene Blue plasma
Time frame: One year
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 9 Sep 2015.
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.
Hafiz Qureshi, MD, PhD principal investigator
University Hospitals, Leicester
Mercedes Villamayor, MD, PhD principal investigator
Complejo Hospitalario Universitario de Santiago
Lucien Noens, MD PhD principal investigator
University Ghent
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adverse Effects in the Therapeutic Use of Plasma Substitutes, run by Maco Productions S.A.S. at 4 sites in 4 countries.
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 9 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium, Greece, Spain, United Kingdom. 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?
The incidence of transfusion reactions following administration of Methylene Blue Plasma based on the total number of transfusions administered (time frame: One year). 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 9 Sep 2015; AzTrials last refreshed its copy on 30 Oct 2026.