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

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.

Study Overview

• Status: Completed
• Conditions: Dengue Virus; Chikungunya Virus
• Intervention / Treatment: Biological: INTERCEPT Platelets

Detailed Description

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).

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• Puerto Rico
  • Aibonito, Puerto Rico, 00705
    • Hospital General Menonita de Aibonito
  • Caguas, Puerto Rico, 00725
    • Hospital General Menonita de Caguas
  • Cayey, Puerto Rico
    • Hospital General Menonita de Cayey
  • Manati, Puerto Rico, 00674
    • Center Hospital Manati
  • Ponce, Puerto Rico, 00733
    • Hospital San Lucas Ponce
  • San German, Puerto Rico, 00683
    • Hospital La Concepcion San German
  • San Juan, Puerto Rico, 00683
    • Centro Cardiovascular de Puerto Rico and the Caribbean
  • San Juan, Puerto Rico, 00921
    • Veteran Administration

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients requiring a platelet transfusion.

Description

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).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Proportion of Transfused INTERCEPT Platelet Components With a Post-treatment Platelet Dose ≥ 3.0×10^11 Platelets.	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.	1 year
The Proportion of Patients With a Confirmed Case of Transfusion-transmitted Chikungunya Virus or Dengue Infection		1 year
The Proportion of Patients With Any Transfusion Reactions	Transfusion reactions are defined as adverse events assessed as possibly, likely/probably or certainly related to the INTERCEPT platelet component transfused.	1 year
The Proportion of Patients With Any Unrelated Adverse Event	Unrelated adverse events are defined as adverse events unrelated to the INTERCEPT platelet component transfused.	1 year
The Proportion of Transfused INTERCEPT Platelet Components Associated With Any Transfusion Reactions and/or Unrelated Adverse Event	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".	1 year

Collaborators and Investigators

• Sponsor: Cerus Corporation
• Collaborators: American National Red Cross
• Investigators: Principal Investigator: Susan L Stramer, PhD, American National Red Cross

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: November 25, 2014
• First Submitted That Met QC Criteria: November 28, 2014
• First Posted (Estimate): December 3, 2014

Study Record Updates

• Last Update Posted (Actual): October 30, 2018
• Last Update Submitted That Met QC Criteria: January 24, 2018
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: platelets; Puerto Rico; Dengue virus; CHIKV; DENV; Chikungunya virus; pathogen inactivation
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Arbovirus Infections; Vector Borne Diseases; Flavivirus Infections; Flaviviridae Infections; Hemorrhagic Fevers, Viral; Alphavirus Infections; Togaviridae Infections; Dengue; Chikungunya Fever
• Other Study ID Numbers: CLI 00108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO