Efficacy and Safety Study of Platelets Treated for Pathogen Inactivation and Stored for Up to Seven Days

Thrombocytopenia Clinical Trial

— TESSI  

Official title:

Clinical Trial to Evaluate the Therapeutic Efficacy and Safety of INTERCEPT Platelets Stored for up to Seven Days After Collection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00261924
• Other study ID #: 451-P-A-NIV
• Status: Completed
• Phase: Phase 3
• First received: December 5, 2005
• Last updated: April 13, 2010
• Start date: October 2005
• Est. completion date: July 2009

Study information

• Verified date: December 2005
• Source: Cerus Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Objective: To determine if platelets treated for pathogen inactivation and stored for 6 to 7 days are safe and effective compared to platelets collected by the same method, stored for the same amount of time and not treated for pathogen inactivation.

Description:

Although the European Commission directive 2004/33/EC states that platelet preparations may be stored for 7 days in conjunction with detection or reduction of bacterial contamination, most blood centers store platelets for only 4 or 5 days. Extending the storage time could greatly improve platelet availability for patients while decreasing wastage of this limited resource.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 211
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• At least 16 years old

• Written informed consent

• Thrombocytopenia, or expected to develop thrombocytopenia requiring platelet transfusion within 15 days of randomization

• Undergoing one haematopoietic stem cell transplantation and/or admitted for treatment of acute or chronic leukaemia, lymphoma, multiple myeloma or myelodysplasia

Exclusion Criteria:

• Refractoriness to platelet transfusion

• Immune-mediated thrombocytopenia, thrombotic thrombocytopenic purpura, or hemolytic uremic syndrome

• Use of IL-11 (Neumega®) or other investigational platelet growth factor

• Disseminated intravascular coagulation (DIC)

• Clinically or radiologically detectable splenomegaly

• Previous participation in the study

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Thrombocytopenia
• Thrombocytosis

Intervention

Device:
• Transfusion of Pathogen Inactivated Platelets stored for 6-7 days
pathogen inactivation of platelets for transfusion

Locations

Country	Name	City	State
United Kingdom	SNBTS National Science Laboratory, Edinburgh and Western General Hospital	Edinburgh

Sponsors (1)

Lead Sponsor	Collaborator
Cerus Corporation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1 hour corrected count increment for platelets	1-h CCI	One hour after platelet transfusion	No
Secondary	Transfusion related adverse events		24 hours after transfusion	Yes