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Safety and Performance of MIRASOL® PRT Treated Platelet Transfusion Products
This study is currently recruiting participants.
Verified by Navigant Biotechnologies, December 2006
Sponsored by: Navigant Biotechnologies
Information provided by: Navigant Biotechnologies
ClinicalTrials.gov Identifier: NCT00263809
  Purpose

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).


Condition Intervention
Thrombocytopenia
Device: Pathogen Reduction Technology

MedlinePlus related topics: Blood Transfusion and Donation
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Evaluation of the Safety and Performance of Platelet Transfusion Products Treated With MIRASOL® Pathogen Reduction Technology. A Study in Human Thrombocytopenic Subjects.

Further study details as provided by Navigant Biotechnologies:

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.

Estimated Enrollment: 118
Study Start Date: December 2005
Estimated Study Completion Date: June 2007
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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00263809

Locations
France
EFS Alsace Recruiting
Strasbourg, France, 67065
Contact: Jean-Pierre CAZENAVE, MD     +33 (3) 88 21 25 25        
Principal Investigator: Jean-Pierre CAZENAVE, MD            
EFS Aquitaine Recruiting
Bordeaux, France, 33035
Contact: Jean-Michel BOIRON, MD     +33 (5) 56 90 83 83        
Principal Investigator: Jean-Michel BOIRON, MD            
EFS Pays de la Loire Recruiting
Nantes, France, 44011
Contact: Gilles FOLLEA, MD     +33 (5) 56 90 83 83        
Principal Investigator: Gilles FOLLEA, MD            
EFS Bourgogne – Franche-Comté Recruiting
Besançon, France, 25020
Contact: Laurent BARDIAUX, MD     +33 (3) 81 61 56 15        
Principal Investigator: Laurent BARDIAUX, MD            
Centre Hospitalier Régional Universitaire Hautepierre Recruiting
Strasbourg, France, 67000
Contact: Bruno LIOURE, MD     +33 (3) 88 12 80 00        
Principal Investigator: Bruno LIOURE, MD            
Centre Hospitalier Univesrsitaire A Michallon Recruiting
La Tronche, France, 38043
Contact: Jean-Yves Cahn, MD     +33 (4) 76 76 59 53        
Principal Investigator: Jean-Yves CAHN, MD            
Centre Hospitalier Universitaire Hôtel Dieu Recruiting
Nantes, France, 44035
Contact: Jean-Luc HAROUSSEAU, MD     +33 (2) 40 08 32 72        
Principal Investigator: Jean-Luc HAROUSSEAU, MD            
Centre Hospitalier Universitaire Jean Minjoz Recruiting
Besançon, France, 25020
Contact: Eric DECONNINCK, MD     +33 (3) 81 66 82 32        
Principal Investigator: Eric DECONNINCK, MD            
EFS Rhône-Alpes (Site de Grenoble) Recruiting
La Tronche, France, 38701
Contact: Bruno LAFEUILLADE, MD     +33 (4) 76 42 43 44        
Principal Investigator: Bruno LAFEUILLADE, MD            
Centre Hospitalier Universitaire de Bordeaux Recruiting
Pessac, France, 33604
Contact: Reza TABRIZI, MD     +33 (5) 57 65 65 11        
Principal Investigator: Reza TABRIZI, MD            
Sponsors and Collaborators
Navigant Biotechnologies
Investigators
Principal Investigator: Jean-Pierre Cazenave, MD Director - EFS Alsace - France
  More Information

Study ID Numbers: CTS-0028
Study First Received: December 7, 2005
Last Updated: December 5, 2006
ClinicalTrials.gov Identifier: NCT00263809  
Health Authority: France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:
Thrombocytopathy
Thrombocytopenia
Hematologic Diseases
Blood Platelet Disorders

ClinicalTrials.gov processed this record on January 16, 2009