Skip to main content
OpenTrials
Completed

NCT Number: NCT02007473

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Adverse Effects in the Therapeutic Use of Plasma Substitutes

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitair Ziekenhuis, Ghent, Belgium

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The incidence of transfusion reactions following administration of Methylene Blue Plasma based on the total number of transfusions administered

    Time frame: One year

Secondary outcomes

  1. The incidence of specific transfusion reactions following administration of Methylene Blue plasma

    Time frame: One year

    The rate of the different type of adverse events registered along the time frame.

Other outcomes

  1. Relationship between transfusion reaction types and indication, gender, age and severity

    Time frame: One year

    Analysis of factors that could be related to transfusion reactions

Sponsors and collaborators

Lead sponsor

Maco Productions S.A.S.

Industry

Collaborators

  • SynteractHCR

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 10, 2013
Registry last updated
Sep 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.