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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-31

Study Completion Date

2015-05-31

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.

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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

Conditions

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Adverse Effects in the Therapeutic Use of Plasma Substitutes

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients requiring transfusion with plasma

Recipients, who have received a transfusion with Methylene Blue plasma produced using the THERAFLEX MB-Plasma procedure from MacoPharma.

No interventions assigned to this group

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.