Clinical trial NCT02305732: A Prospective, Open Label, Treatment Use Study of Patient Safety Following Transfusion of INTERCEPT Platelet Components
Official title: A Prospective, Open Label, Treatment Use Study of Patient Safety Following Transfusion of INTERCEPT Platelet Components
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chikungunya Virus
Dengue Virus
Keywords: Chikungunya virus
CHIKV
Dengue virus
DENV
pathogen inactivation
platelets
Puerto Rico
Lead sponsor: Cerus Corporation
Sponsor class: INDUSTRY
Collaborators: name: American National Red Cross
First posted: 2014-12-03
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients requiring a platelet transfusion.

Brief summary: 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.

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).

Eligibility criteria: 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).

Primary outcomes:
measure: The Proportion of Transfused INTERCEPT Platelet Components With a Post-treatment Platelet Dose ≥ 3.0×10^11 Platelets.
timeFrame: 1 year
measure: The Proportion of Patients With a Confirmed Case of Transfusion-transmitted Chikungunya Virus or Dengue Infection
timeFrame: 1 year
measure: The Proportion of Patients With Any Transfusion Reactions
timeFrame: 1 year
measure: The Proportion of Patients With Any Unrelated Adverse Event
timeFrame: 1 year
measure: The Proportion of Transfused INTERCEPT Platelet Components Associated With Any Transfusion Reactions and/or Unrelated Adverse Event
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Aibonito
country: Puerto Rico
facility: Hospital General Menonita de Aibonito
city: Caguas
country: Puerto Rico
facility: Hospital General Menonita de Caguas
city: Cayey
country: Puerto Rico
facility: Hospital General Menonita de Cayey
city: Manati
country: Puerto Rico
facility: Center Hospital Manati
city: Ponce
country: Puerto Rico
facility: Hospital San Lucas Ponce
city: San German
country: Puerto Rico
facility: Hospital La Concepcion San German
city: San Juan
country: Puerto Rico
facility: Centro Cardiovascular de Puerto Rico and the Caribbean
city: San Juan
country: Puerto Rico
facility: Veteran Administration
Study officials:
affiliation: American National Red Cross
name: Susan L Stramer, PhD
role: PRINCIPAL_INVESTIGATOR
References: