Clinical trial NCT00263809: 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
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Thrombocytopenia
Lead sponsor: Terumo BCTbio
Sponsor class: INDUSTRY
First posted: 2005-12-09
Enrollment: 118
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The platelet corrected count increment measured 1 hour post transfusion.
Secondary outcomes:
measure: The platelet corrected count increment measured 24 hours post-transfusion.
measure: The number of days between platelet transfusions during the period of the study.
measure: The number of platelet transfusions per subject.
measure: The number of platelets infused per subject.
measure: The number of platelets used.
measure: The frequency of refractoriness to platelet transfusion.
measure: In case of refractoriness, the evidence for neoantigen immunization against test product.
measure: The number of red blood cell transfusions during the study period.
measure: The incidence of serious adverse events in relation to platelet transfusions.
measure: The incidence of any adverse events in relation to platelet transfusions.
measure: The occurrence of bleeding episodes.
Other outcomes:
Locations:
city: Besançon
country: France
facility: Centre Hospitalier Universitaire Jean Minjoz
city: Besançon
country: France
facility: EFS Bourgogne - Franche-Comté
city: Bordeaux
country: France
facility: EFS Aquitaine
city: La Tronche
country: France
facility: Centre Hospitalier Univesrsitaire A Michallon
city: La Tronche
country: France
facility: EFS Rhône-Alpes (Site de Grenoble)
city: Nantes
country: France
facility: EFS Pays de la Loire
city: Nantes
country: France
facility: Centre Hospitalier Universitaire Hôtel Dieu
city: Pessac
country: France
facility: Centre Hospitalier Universitaire de Bordeaux
city: Strasbourg
country: France
facility: Centre Hospitalier Régional Universitaire Hautepierre
city: Strasbourg
country: France
facility: EFS Alsace
Study officials:
affiliation: Director - EFS Alsace - France
name: Jean-Pierre Cazenave, MD
role: PRINCIPAL_INVESTIGATOR
References: