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| Sponsored by: |
Etablissement Français du Sang |
| Information provided by: | Etablissement Français du Sang |
| ClinicalTrials.gov Identifier: | NCT00235183 |
Purpose
The aim of the study is to compare the clinical efficacy of three types of plasma secured on the viral level either by quarantine or by chemical treatment in patients undergoing liver transplantation.
| Condition | Intervention | Phase |
|
Bleeding in Liver Transplantation |
Drug: plasma |
Phase IV |
| MedlinePlus related topics: | Blood Transfusion and Donation Liver Transplantation |
| ChemIDplus related topics: | Methylene blue |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Plasma Transfusion in Liver Transplantation : a Randomized, Double Blind, Multicenter Trial of Methylene Blue, Solvent/Detergent and Quarantined Plasma. |
| Estimated Enrollment: | 300 |
| Study Start Date: | June 2005 |
| Estimated Study Completion Date: | December 2007 |
Three types of plasma are transfused in bleeding patients undergoing liver transplantation:
In addition, the correction of coagulation abnormalities are studied.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Françoise Courtois, MD | 33 1 44 49 66 07 | francoise.courtois@efs.sante.fr |
| Contact: Anne Chabanel, ScD | 33 1 44 49 66 14 | anne.chabanel@efs.sante.fr |
| France | |||||
| EFS | Recruiting | ||||
| Paris, France, 75015 | |||||
| Contact: Françoise Courtois, MD 33 1 44 49 66 07 francoise.courtois@efs.sante.fr | |||||
| Contact: Anne Chabanel, ScD 33 1 44 49 66 14 anne.chabanel@efs.sante.fr | |||||
| Principal Investigator: Françoise Courtois, MD | |||||
| Etablissement Français du Sang |
| Principal Investigator: | Yves Ozier, MD, PhD | Hôpital Cochin, Paris, France |
| Principal Investigator: | Emmanuel Samain, MD, PhD | hôpital Jean Minjoz, Besançon, France |
| Principal Investigator: | Marie - Christine Gillon, MD | Hôpital Paul Brousse, Villejuif, France |
| Principal Investigator: | Loïc Villalon, MD | Hôpital Pontchaillou |
More Information
| Study ID Numbers: | EFS plasma trial |
| First Received: | October 6, 2005 |
| Last Updated: | October 5, 2006 |
| ClinicalTrials.gov Identifier: | NCT00235183 |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
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