Safety and Performance of MIRASOL® PRT Treated Platelet Transfusion Products

Terumo

Status and phase

Completed

Early Phase 1

Conditions

Thrombocytopenia

Treatments

Device: Pathogen Reduction Technology

Study type

Interventional

Funder types

Industry

Identifiers

NCT00263809

CTS-0028

Details and patient eligibility

About

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).

Full 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.

Enrollment

118 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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