NCT02007473

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2013

Geographic Reach
4 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 10, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

September 9, 2015

Status Verified

September 1, 2015

Enrollment Period

1.8 years

First QC Date

November 29, 2013

Last Update Submit

September 8, 2015

Conditions

Adverse Effects in the Therapeutic Use of Plasma Substitutes

Keywords

HaemovigilancePlasmaPathogen reductionMethylene Blue

Outcome Measures

Primary Outcomes (1)

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

    One year

Secondary Outcomes (1)

  • The incidence of specific transfusion reactions following administration of Methylene Blue plasma

    One year

Other Outcomes (1)

  • Relationship between transfusion reaction types and indication, gender, age and severity

    One year

Study Arms (1)

Patients requiring transfusion with plasma

Recipients, who have received a transfusion with Methylene Blue plasma produced using the THERAFLEX MB-Plasma procedure from MacoPharma.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Inpatients requiring plasma transfusion

You may qualify if:

  • Patients, who have received a transfusion with Methylene Blue plasma produced using the THERAFLEX MB-Plasma procedure from MacoPharma and experience an adverse reaction.

You may not qualify if:

  • Patients receiving transfusion with other plasma types during the same transfusion episode

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Universitair Ziekenhuis

Ghent, 9000, Belgium

Location

G. H. A. Evaggelismos

Athens, 10676, Greece

Location

Complexo Hospitalario Universitario

Santiago de Compostela, La Coruña, 15706, Spain

Location

University Hospitals of Leicester NHS Trust

Leicester, LE1 5WW, United Kingdom

Location

Study Officials

  • Hafiz Qureshi, MD, PhD

    University Hospitals, Leicester

    PRINCIPAL INVESTIGATOR

  • Mercedes Villamayor, MD, PhD

    Complejo Hospitalario Universitario de Santiago

    PRINCIPAL INVESTIGATOR

  • Lucien Noens, MD PhD

    University Ghent

    PRINCIPAL INVESTIGATOR

  • Aggeliki Megalou, MD PhD

    G. H. A. Evaggelismos, Athens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2013

First Posted

December 10, 2013

Study Start

July 1, 2013

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

September 9, 2015

Record last verified: 2015-09

Locations

ES(1)GB(1)GR(1)BE(1)