A Prospective Non-interventional Study to Evaluate the Safety of Methylene Blue Plasma

Study Overview
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Brief Summary
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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
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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

Official Title
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A Prospective Non-interventional Study to Evaluate the Safety of Methylene Blue Plasma

Conditions
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Adverse Effects in the Therapeutic Use of Plasma Substitutes

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients, who have received a transfusion with Methylene Blue plasma produced using the THERAFLEX MB-Plasma procedure from MacoPharma and experience an adverse reaction. Exclusion Criteria: Patients receiving transfusion with other plasma types during the same transfusion episode
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients requiring transfusion with plasma<br>Recipients, who have received a transfusion with Methylene Blue plasma produced using the THERAFLEX MB-Plasma procedure from MacoPharma. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of transfusion reactions following administration of Methylene Blue Plasma based on the total number of transfusions administered |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Haemovigilance, Plasma, Pathogen reduction, Methylene Blue