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

Completed

• Conditions: Adverse Effects in the Therapeutic Use of Plasma Substitutes

• Registration Number: NCT02007473
• Lead Sponsor: Maco Productions S.A.S.

Brief 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.

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 Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-11-29
• Study First Submitted QC: 2013-12-05
• Study First Posted: 2013-12-10
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-08
• Last Update Posted: 2015-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The incidence of transfusion reactions following administration of Methylene Blue Plasma based on the total number of transfusions administered	One year

Secondary Outcome Measures

Name	Time	Method
The incidence of specific transfusion reactions following administration of Methylene Blue plasma	One year	The rate of the different type of adverse events registered along the time frame.

Trial Locations

Locations (4)

Universitair Ziekenhuis; 🇧🇪 Gent, Belgium

Complexo Hospitalario Universitario; 🇪🇸 Santiago de Compostela, La Coruña, Spain

G. H. A. Evaggelismos; 🇬🇷 Athens, Greece

University Hospitals of Leicester NHS Trust; 🇬🇧 Leicester, United Kingdom