Safety and Performance of MIRASOL® PRT Treated Platelet Transfusion Products

This study has been completed.
Sponsor:
Information provided by:
Terumo BCTbio
ClinicalTrials.gov Identifier:
NCT00263809
First received: December 7, 2005
Last updated: October 6, 2009
Last verified: October 2009
  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 Phase
Thrombocytopenia
Device: Pathogen Reduction Technology
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Safety and Performance of Platelet Transfusion Products Treated With MIRASOL® Pathogen Reduction Technology. A Study in Human Thrombocytopenic Subjects.

Resource links provided by NLM:


Further study details as provided by Terumo BCTbio:

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.

Enrollment: 118
Study Start Date: December 2005
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Treatment, Mirasol-treated platelets
Device: Pathogen Reduction Technology
No Intervention: 2
Reference, Untreated platelets

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
Centre Hospitalier Universitaire Jean Minjoz
Besançon, France, 25020
EFS Bourgogne - Franche-Comté
Besançon, France, 25020
EFS Aquitaine
Bordeaux, France, 33035
EFS Rhône-Alpes (Site de Grenoble)
La Tronche, France, 38701
Centre Hospitalier Univesrsitaire A Michallon
La Tronche, France, 38043
EFS Pays de la Loire
Nantes, France, 44011
Centre Hospitalier Universitaire Hôtel Dieu
Nantes, France, 44035
Centre Hospitalier Universitaire de Bordeaux
Pessac, France, 33604
EFS Alsace
Strasbourg, France, 67065
Centre Hospitalier Régional Universitaire Hautepierre
Strasbourg, France, 67000
Sponsors and Collaborators
Terumo BCTbio
Investigators
Principal Investigator: Jean-Pierre Cazenave, MD Director - EFS Alsace - France
  More Information

No publications provided

Responsible Party: Tracy Roberts, Director of Clinical Affairs, Navigant Biotechnologies
ClinicalTrials.gov Identifier: NCT00263809     History of Changes
Other Study ID Numbers: CTS-0028
Study First Received: December 7, 2005
Last Updated: October 6, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases

ClinicalTrials.gov processed this record on April 16, 2014