Safety and Performance of MIRASOL® PRT Treated Platelet Transfusion Products
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00263809|
Recruitment Status : Completed
First Posted : December 9, 2005
Last Update Posted : October 7, 2009
|Condition or disease||Intervention/treatment||Phase|
|Thrombocytopenia||Device: Pathogen Reduction Technology||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||118 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||December 2005|
|Actual Primary Completion Date :||October 2007|
|Actual Study Completion Date :||October 2007|
Treatment, Mirasol-treated platelets
|Device: Pathogen Reduction Technology|
No Intervention: 2
Reference, Untreated platelets
- The platelet corrected count increment measured 1 hour post transfusion.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00263809
|Centre Hospitalier Universitaire Jean Minjoz|
|Besançon, France, 25020|
|EFS Bourgogne - Franche-Comté|
|Besançon, France, 25020|
|Bordeaux, France, 33035|
|Centre Hospitalier Univesrsitaire A Michallon|
|La Tronche, France, 38043|
|EFS Rhône-Alpes (Site de Grenoble)|
|La Tronche, France, 38701|
|EFS Pays de la Loire|
|Nantes, France, 44011|
|Centre Hospitalier Universitaire Hôtel Dieu|
|Nantes, France, 44035|
|Centre Hospitalier Universitaire de Bordeaux|
|Pessac, France, 33604|
|Centre Hospitalier Régional Universitaire Hautepierre|
|Strasbourg, France, 67000|
|Strasbourg, France, 67065|
|Principal Investigator:||Jean-Pierre Cazenave, MD||Director - EFS Alsace - France|