Skip to main content
OpenTrials
Completed

NCT Number: NCT02305732

A Prospective, Open Label, Treatment Use Study of Patient Safety Following Transfusion of INTERCEPT Platelet Components

The rationale for a Treatment Use Investigational Device Exemption (IDE) of INTERCEPT PCs is to address current gaps in platelet transfusion safety in selected geographic regions. The objective is to provide access to INTERCEPT PCs for patients who might be at risk of transfusion-transmitted infection (TTI) due to Chikungunya virus (CHIKV) and Dengue virus (DENV) in regions in which a substantial proportion of the population has been infected or is at risk of infection by these pathogens (Petersen 2014); and the risk of asymptomatic infection among qualified blood donors is recognized (Stramer 2012, Adda 2014).

The study is designed as a prospective, open label, multi-center, observational study to evaluate the safety and efficacy of INTERCEPT platelet components.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chikungunya Virus Dengue Virus

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital General Menonita de Aibonito, Aibonito, Puerto Rico

Loading trial locations.

About this study

Upon written informed consent, patients will be transfused with study PCs according to local practices. Each patient will be supported with platelets as clinically indicated in a manner that is consistent with the local standard of care. The study will be conducted in two phases. During the pilot phase, patients will sign informed consent to have study data collected following transfusion with conventional PCs. The objective of the pilot phase is to evaluate study logistics and data collection methods. During the INTERCEPT Treatment Use phase, patients will sign informed consent to receive INTERCEPT PCs, provide blood samples, and collect study data (demographics, transfusion data, and safety data).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with a serious disease expected to require or requiring a transfusion of platelet component(s)
  • Patient population as defined by each Investigator and their institutional review board (IRB).
  • Patient provides written informed consent

Exclusion criteria

  • Documented allergy to psoralens
  • Neonatal patients treated with phototherapy devices that emit wavelengths less than 425 nm due to the potential for erythema resulting from interaction between ultraviolet light and amotosalen.
  • Pregnant women in their third trimester of pregnancy (due to possibility the neonate may need bilirubin light treatment after birth).

Treatment and study plan

INTERCEPT Platelets

Biological

INTERCEPT platelet components (PC). Leukocyte reduced apheresis platelet components collected in Platelet Additive Solution (PAS) or 100% plasma without gamma irradiation, bacterial detection, and Cytomegalovirus (CMV) serology testing.

Primary outcomes

  1. The Proportion of Transfused INTERCEPT Platelet Components With a Post-treatment Platelet Dose ≥ 3.0×10^11 Platelets.

    Time frame: 1 year

    INTERCEPT platelet components (PCs) manufactured for this study are leukocyte reduced apheresis PCs processed using the INTERCEPT Blood System (IBS) for platelets. The IBS for platelets is a Class III medical device approved by the FDA for the ex-vivo preparation and storage of pathogen reduced apheresis PCs. The system is used to inactivate a broad range of pathogens, including viruses, bacteria, and protozoan parasites as well as contaminating donor leukocytes. Post-manufacturing, INTERCEPT PCs are either transfused or stored according to blood center standard operating procedures, US FDA, and AABB Guidelines.

    Subjects enrolled in this study are transfused with INTERCEPT PCs as dictated by the treating physician. One platelet component was treated as one platelet transfusion for the purpose of data analysis in this study.

  2. The Proportion of Patients With a Confirmed Case of Transfusion-transmitted Chikungunya Virus or Dengue Infection

    Time frame: 1 year

  3. The Proportion of Patients With Any Transfusion Reactions

    Time frame: 1 year

    Transfusion reactions are defined as adverse events assessed as possibly, likely/probably or certainly related to the INTERCEPT platelet component transfused.

  4. The Proportion of Patients With Any Unrelated Adverse Event

    Time frame: 1 year

    Unrelated adverse events are defined as adverse events unrelated to the INTERCEPT platelet component transfused.

  5. The Proportion of Transfused INTERCEPT Platelet Components Associated With Any Transfusion Reactions and/or Unrelated Adverse Event

    Time frame: 1 year

    Transfusion reactions are defined as adverse events assessed as possibly, likely/probably or certainly related to the INTERCEPT platelet component transfused.

    Unrelated adverse events are defined as adverse events unrelated to the INTERCEPT platelet component transfused.

    ""1 Transfusion = 1 Intercept Platelet Component".

Sponsors and collaborators

Lead sponsor

Cerus Corporation

Industry

Collaborators

  • American National Red Cross

Registry information

Acronym: TRUE

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 3, 2014
Registry last updated
Oct 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.