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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 8

Contacts and Locations

Study Locations

• Belgium
  • Gent, Belgium, 9000
    • Universitair Ziekenhuis
• Greece
  • Athens, Greece, 10676
    • G. H. A. Evaggelismos
• Spain
  • La Coruña
    • Santiago de Compostela, La Coruña, Spain, 15706
      • Complexo Hospitalario Universitario
• United Kingdom
  • Leicester, United Kingdom, LE1 5WW
    • University Hospitals of Leicester NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Inpatients requiring plasma transfusion

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients requiring transfusion with plasma; Recipients, who have received a transfusion with Methylene Blue plasma produced using the THERAFLEX MB-Plasma procedure from MacoPharma.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relationship between transfusion reaction types and indication, gender, age and severity	Analysis of factors that could be related to transfusion reactions	One year

Collaborators and Investigators

• Sponsor: Maco Productions S.A.S.
• Collaborators: SynteractHCR
• Investigators: Principal Investigator: Hafiz Qureshi, MD, PhD, University Hospitals, Leicester; Principal Investigator: Mercedes Villamayor, MD, PhD, Complejo Hospitalario Universitario de Santiago; Principal Investigator: Lucien Noens, MD PhD, Universitair Ziekenhuis Gent; Principal Investigator: Aggeliki Megalou, MD PhD, G. H. A. Evaggelismos, Athens

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: November 29, 2013
• First Submitted That Met QC Criteria: December 5, 2013
• First Posted (Estimate): December 10, 2013

Study Record Updates

• Last Update Posted (Estimate): September 9, 2015
• Last Update Submitted That Met QC Criteria: September 8, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Plasma; Methylene Blue; Pathogen reduction; Haemovigilance
• Other Study ID Numbers: 1974/MCP