Clinical trial NCT02007473: A Prospective Non-interventional Study to Evaluate the Safety of Methylene Blue Plasma
Official title: A Prospective Non-interventional Study to Evaluate the Safety of Methylene Blue Plasma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adverse Effects in the Therapeutic Use of Plasma Substitutes
Keywords: Haemovigilance
Plasma
Pathogen reduction
Methylene Blue
Lead sponsor: Maco Productions S.A.S.
Sponsor class: INDUSTRY
Collaborators: name: SynteractHCR
First posted: 2013-12-10
Enrollment: 8
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inpatients requiring plasma transfusion

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

Eligibility criteria: 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

Primary outcomes:
measure: The incidence of transfusion reactions following administration of Methylene Blue Plasma based on the total number of transfusions administered
timeFrame: One year
Secondary outcomes:
measure: The incidence of specific transfusion reactions following administration of Methylene Blue plasma
timeFrame: One year
Other outcomes:
measure: Relationship between transfusion reaction types and indication, gender, age and severity
timeFrame: One year
Locations:
city: Gent
country: Belgium
facility: Universitair Ziekenhuis
city: Athens
country: Greece
facility: G. H. A. Evaggelismos
city: Santiago de Compostela
country: Spain
facility: Complexo Hospitalario Universitario
state: La Coruña
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester NHS Trust
Study officials:
affiliation: University Hospitals, Leicester
name: Hafiz Qureshi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Complejo Hospitalario Universitario de Santiago
name: Mercedes Villamayor, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitair Ziekenhuis Gent
name: Lucien Noens, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: G. H. A. Evaggelismos, Athens
name: Aggeliki Megalou, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: