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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00261924

Acronym

TESSI

Enrollment

211

Registered

2005-12-06

Start date

2005-10-31

Completion date

2009-07-31

Last updated

2010-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thrombocytopenia

Keywords

Thrombocytopenic patients

Brief 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.

Detailed 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.

Interventions

DEVICETransfusion of Pathogen Inactivated Platelets stored for 6-7 days

pathogen inactivation of platelets for transfusion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
1 hour corrected count increment for platelets	One hour after platelet transfusion	1-h CCI

Secondary

Measure	Time frame
Transfusion related adverse events	24 hours after transfusion

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026