Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Navigant Biotechnologies |
---|---|
Information provided by: | Navigant Biotechnologies |
ClinicalTrials.gov Identifier: | NCT00263809 |
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 |
---|---|
Thrombocytopenia |
Device: Pathogen Reduction Technology |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Evaluation of the Safety and Performance of Platelet Transfusion Products Treated With MIRASOL® Pathogen Reduction Technology. A Study in Human Thrombocytopenic Subjects. |
Estimated Enrollment: | 118 |
Study Start Date: | December 2005 |
Estimated Study Completion Date: | June 2007 |
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.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France | |
EFS Alsace | Recruiting |
Strasbourg, France, 67065 | |
Contact: Jean-Pierre CAZENAVE, MD +33 (3) 88 21 25 25 | |
Principal Investigator: Jean-Pierre CAZENAVE, MD | |
EFS Aquitaine | Recruiting |
Bordeaux, France, 33035 | |
Contact: Jean-Michel BOIRON, MD +33 (5) 56 90 83 83 | |
Principal Investigator: Jean-Michel BOIRON, MD | |
EFS Pays de la Loire | Recruiting |
Nantes, France, 44011 | |
Contact: Gilles FOLLEA, MD +33 (5) 56 90 83 83 | |
Principal Investigator: Gilles FOLLEA, MD | |
EFS Bourgogne – Franche-Comté | Recruiting |
Besançon, France, 25020 | |
Contact: Laurent BARDIAUX, MD +33 (3) 81 61 56 15 | |
Principal Investigator: Laurent BARDIAUX, MD | |
Centre Hospitalier Régional Universitaire Hautepierre | Recruiting |
Strasbourg, France, 67000 | |
Contact: Bruno LIOURE, MD +33 (3) 88 12 80 00 | |
Principal Investigator: Bruno LIOURE, MD | |
Centre Hospitalier Univesrsitaire A Michallon | Recruiting |
La Tronche, France, 38043 | |
Contact: Jean-Yves Cahn, MD +33 (4) 76 76 59 53 | |
Principal Investigator: Jean-Yves CAHN, MD | |
Centre Hospitalier Universitaire Hôtel Dieu | Recruiting |
Nantes, France, 44035 | |
Contact: Jean-Luc HAROUSSEAU, MD +33 (2) 40 08 32 72 | |
Principal Investigator: Jean-Luc HAROUSSEAU, MD | |
Centre Hospitalier Universitaire Jean Minjoz | Recruiting |
Besançon, France, 25020 | |
Contact: Eric DECONNINCK, MD +33 (3) 81 66 82 32 | |
Principal Investigator: Eric DECONNINCK, MD | |
EFS Rhône-Alpes (Site de Grenoble) | Recruiting |
La Tronche, France, 38701 | |
Contact: Bruno LAFEUILLADE, MD +33 (4) 76 42 43 44 | |
Principal Investigator: Bruno LAFEUILLADE, MD | |
Centre Hospitalier Universitaire de Bordeaux | Recruiting |
Pessac, France, 33604 | |
Contact: Reza TABRIZI, MD +33 (5) 57 65 65 11 | |
Principal Investigator: Reza TABRIZI, MD |
Principal Investigator: | Jean-Pierre Cazenave, MD | Director - EFS Alsace - France |
Study ID Numbers: | CTS-0028 |
Study First Received: | December 7, 2005 |
Last Updated: | December 5, 2006 |
ClinicalTrials.gov Identifier: | NCT00263809 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Thrombocytopathy Thrombocytopenia Hematologic Diseases Blood Platelet Disorders |