Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2025-12-24 @ 9:23 PM
NCT ID:
NCT02305732
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).
Study:
NCT02305732
Study Brief:
Protocol Section:
NCT02305732