Status:
COMPLETED
Safety and Performance of MIRASOL® PRT Treated Platelet Transfusion Products
Lead Sponsor:
Terumo BCTbio
Conditions:
Thrombocytopenia
Eligibility:
All Genders
16+ years
Phase:
EARLY_PHASE1
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 m...
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 sett...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT00263809
Start Date
December 1 2005
End Date
October 1 2007
Last Update
October 7 2009
Active Locations (10)
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1
Centre Hospitalier Universitaire Jean Minjoz
Besançon, France, 25020
2
EFS Bourgogne - Franche-Comté
Besançon, France, 25020
3
EFS Aquitaine
Bordeaux, France, 33035
4
Centre Hospitalier Univesrsitaire A Michallon
La Tronche, France, 38043