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

Adverse Effects in the Therapeutic Use of Plasma Substitutes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02007473
• Other study ID #: 1974/MCP
• Status: Completed
• Phase: N/A
• First received: November 29, 2013
• Last updated: September 8, 2015
• Start date: July 2013
• Est. completion date: May 2015

Study information

• Verified date: September 2015
• Source: Maco Productions S.A.S.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health ServiceSpain: Agencia Española de Medicamentos y Productos SanitariosBelgium: Federal Agency for Medicinal Products and Health ProductsGreece: Ethics Committee
• Study type: Observational

Clinical 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Adverse Effects in the Therapeutic Use of Plasma Substitutes

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis	Gent
Greece	G. H. A. Evaggelismos	Athens
Spain	Complexo Hospitalario Universitario	Santiago de Compostela	La Coruña
United Kingdom	University Hospitals of Leicester NHS Trust	Leicester

Sponsors (2)

Lead Sponsor	Collaborator
Maco Productions S.A.S.	SynteractHCR

Countries where clinical trial is conducted

Belgium,  Greece,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Relationship between transfusion reaction types and indication, gender, age and severity	Analysis of factors that could be related to transfusion reactions	One year	Yes
Primary	The incidence of transfusion reactions following administration of Methylene Blue Plasma based on the total number of transfusions administered		One year	Yes
Secondary	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	Yes