Back to resultsSafety and Performance of MIRASOL® PRT Treated Platelet Transfusion Products
Primary Purpose
Thrombocytopenia
Status
Completed
Phase
Early Phase 1
Locations
France
Study Type
Interventional
Intervention
Pathogen Reduction Technology
Sponsored by
About this trial
This is an interventional treatment trial for Thrombocytopenia
Eligibility Criteria
Inclusion Criteria: Male or female of age of 16 years or older Women of Child Bearing Potential not pregnant Subject must have signed and dated the Informed Consent form Hospitalized, thrombocytopenic subjects and expected to receive at least two platelets transfusion Exclusion Criteria: History of any hypersensitivity reaction to riboflavin or metabolites History of refractoriness to platelet transfusions Positive lymphocytotoxic antibody test Active bleeding Splenomegaly Acute or chronic Disseminated Intravascular Coagulation History or diagnosis of Immune/Idiopathic Thrombocytopenic Purpura, Thrombotic Thrombocytopenia Purpura, or Haemolytic Uremic Syndrome History or diagnosis of an autoimmune disease affecting haemostasis History of solid organ transplants Evidence of occlusive venous disease Clinical signs of infection at the time of inclusion Pregnant or lactating females Chronic alcohol misuse Use of prohibited medications
Sites / Locations
- Centre Hospitalier Universitaire Jean Minjoz
- EFS Bourgogne - Franche-Comté
- EFS Aquitaine
- Centre Hospitalier Univesrsitaire A Michallon
- EFS Rhône-Alpes (Site de Grenoble)
- EFS Pays de la Loire
- Centre Hospitalier Universitaire Hôtel Dieu
- Centre Hospitalier Universitaire de Bordeaux
- Centre Hospitalier Régional Universitaire Hautepierre
- EFS Alsace
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1
2
Arm Description
Treatment, Mirasol-treated platelets
Reference, Untreated platelets
Outcomes
Primary Outcome Measures
The platelet corrected count increment measured 1 hour post transfusion.
Secondary Outcome Measures
The platelet corrected count increment measured 24 hours post-transfusion.
The number of days between platelet transfusions during the period of the study.
The number of platelet transfusions per subject.
The number of platelets infused per subject.
The number of platelets used.
The frequency of refractoriness to platelet transfusion.
In case of refractoriness, the evidence for neoantigen immunization against test product.
The number of red blood cell transfusions during the study period.
The incidence of serious adverse events in relation to platelet transfusions.
The incidence of any adverse events in relation to platelet transfusions.
The occurrence of bleeding episodes.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00263809
Brief Title
Safety and Performance of MIRASOL® PRT Treated Platelet Transfusion Products
Official Title
Evaluation of the Safety and Performance of Platelet Transfusion Products Treated With MIRASOL® Pathogen Reduction Technology. A Study in Human Thrombocytopenic Subjects.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Terumo BCTbio
4. Oversight
5. Study Description
Brief Summary
The primary objective of the study is to measure platelet corrected count increments and the incidence of serious adverse events (SAE). The primary endpoint is the platelet corrected count increment measured 1-hour post transfusion in response to the infusion of platelet concentrates treated with the Mirasol PRT System device (test product) versus untreated (reference product).
Detailed Description
The objective of the study is to determine if the MIRASOL Pathogen Reduction Technology (PRT) System for Platelets device performs safely and maintains adequate platelet performance in a clinical setting. This will be achieved by comparing the platelet corrected count increment measured 1 hour post transfusion and the incidence of serious adverse events in response to the infusion of platelet concentrates treated with the device (test product) versus untreated (reference product) in thrombocytopenic subjects requiring platelet transfusions. The performance, safety, and tolerability profile of the device will be further assessed by monitoring and comparing the incidence of discontinuations due to adverse events in relation to platelet transfusion up to 4 weeks after transfusion, including the incidence of transfusion associated infections, and the number and time between transfusions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombocytopenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
118 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Treatment, Mirasol-treated platelets
Arm Title
2
Arm Type
No Intervention
Arm Description
Reference, Untreated platelets
Intervention Type
Device
Intervention Name(s)
Pathogen Reduction Technology
Primary Outcome Measure Information:
Title
The platelet corrected count increment measured 1 hour post transfusion.
Secondary Outcome Measure Information:
Title
The platelet corrected count increment measured 24 hours post-transfusion.
Title
The number of days between platelet transfusions during the period of the study.
Title
The number of platelet transfusions per subject.
Title
The number of platelets infused per subject.
Title
The number of platelets used.
Title
The frequency of refractoriness to platelet transfusion.
Title
In case of refractoriness, the evidence for neoantigen immunization against test product.
Title
The number of red blood cell transfusions during the study period.
Title
The incidence of serious adverse events in relation to platelet transfusions.
Title
The incidence of any adverse events in relation to platelet transfusions.
Title
The occurrence of bleeding episodes.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female of age of 16 years or older
Women of Child Bearing Potential not pregnant
Subject must have signed and dated the Informed Consent form
Hospitalized, thrombocytopenic subjects and expected to receive at least two platelets transfusion
Exclusion Criteria:
History of any hypersensitivity reaction to riboflavin or metabolites
History of refractoriness to platelet transfusions
Positive lymphocytotoxic antibody test
Active bleeding
Splenomegaly
Acute or chronic Disseminated Intravascular Coagulation
History or diagnosis of Immune/Idiopathic Thrombocytopenic Purpura, Thrombotic Thrombocytopenia Purpura, or Haemolytic Uremic Syndrome
History or diagnosis of an autoimmune disease affecting haemostasis
History of solid organ transplants
Evidence of occlusive venous disease
Clinical signs of infection at the time of inclusion
Pregnant or lactating females
Chronic alcohol misuse
Use of prohibited medications
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Pierre Cazenave, MD
Organizational Affiliation
Director - EFS Alsace - France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire Jean Minjoz
City
Besançon
ZIP/Postal Code
25020
Country
France
Facility Name
EFS Bourgogne - Franche-Comté
City
Besançon
ZIP/Postal Code
25020
Country
France
Facility Name
EFS Aquitaine
City
Bordeaux
ZIP/Postal Code
33035
Country
France
Facility Name
Centre Hospitalier Univesrsitaire A Michallon
City
La Tronche
ZIP/Postal Code
38043
Country
France
Facility Name
EFS Rhône-Alpes (Site de Grenoble)
City
La Tronche
ZIP/Postal Code
38701
Country
France
Facility Name
EFS Pays de la Loire
City
Nantes
ZIP/Postal Code
44011
Country
France
Facility Name
Centre Hospitalier Universitaire Hôtel Dieu
City
Nantes
ZIP/Postal Code
44035
Country
France
Facility Name
Centre Hospitalier Universitaire de Bordeaux
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Centre Hospitalier Régional Universitaire Hautepierre
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
EFS Alsace
City
Strasbourg
ZIP/Postal Code
67065
Country
France
12. IPD Sharing Statement
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Safety and Performance of MIRASOL® PRT Treated Platelet Transfusion Products
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