Clincosm LogoSign in Get a demo

Safety and Performance of MIRASOL® PRT Treated Platelet Transfusion Products

Sponsor
Terumo BCTbio (Industry)
Overall Status
Completed
CT.gov ID
NCT00263809
Collaborator
(none)
118
Enrollment
10
Locations
2
Arms
22
Duration (Months)
11.8
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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 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 or Disease Intervention/Treatment Phase
  • Device: Pathogen Reduction Technology
 Early Phase 1

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 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
118 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 :
Dec 1, 2005
Actual Primary Completion Date :
Oct 1, 2007
Actual Study Completion Date :
Oct 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Treatment, Mirasol-treated platelets

Device: Pathogen Reduction Technology
No Intervention: 2

Reference, Untreated platelets

Outcome Measures

Primary Outcome Measures

  1. The platelet corrected count increment measured 1 hour post transfusion. []

Secondary Outcome Measures

  1. The platelet corrected count increment measured 24 hours post-transfusion. []

  2. The number of days between platelet transfusions during the period of the study. []

  3. The number of platelet transfusions per subject. []

  4. The number of platelets infused per subject. []

  5. The number of platelets used. []

  6. The frequency of refractoriness to platelet transfusion. []

  7. In case of refractoriness, the evidence for neoantigen immunization against test product. []

  8. The number of red blood cell transfusions during the study period. []

  9. The incidence of serious adverse events in relation to platelet transfusions. []

  10. The incidence of any adverse events in relation to platelet transfusions. []

  11. The occurrence of bleeding episodes. []

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
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
5 EFS Rhône-Alpes (Site de Grenoble) La Tronche France 38701
6 EFS Pays de la Loire Nantes France 44011
7 Centre Hospitalier Universitaire Hôtel Dieu Nantes France 44035
8 Centre Hospitalier Universitaire de Bordeaux Pessac France 33604
9 Centre Hospitalier Régional Universitaire Hautepierre Strasbourg France 67000
10 EFS Alsace Strasbourg France 67065

Sponsors and Collaborators

  • Terumo BCTbio

Investigators

  • Principal Investigator: Jean-Pierre Cazenave, MD, Director - EFS Alsace - France

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00263809
Other Study ID Numbers:
  • CTS-0028
First Posted:
Dec 9, 2005
Last Update Posted:
Oct 7, 2009
Last Verified:
Oct 1, 2009
Additional relevant MeSH terms:
Thrombocytopenia

Study Results

No Results Posted as of Oct 7, 2009