A Non-Interventional Post-Market Clinical Follow-up Study of Patients Transfused with Blood Components Treated with the INTERCEPT Blood System in Routine Therapeutic Use (HV6)

Study identification

• EU PAS number:
  EUPAS49030
• Study ID:
  49031
• Official title and acronym:
  A Non-Interventional Post-Market Clinical Follow-up Study of Patients Transfused with Blood Components Treated with the INTERCEPT Blood System in Routine Therapeutic Use (HV6)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Poland
• Study description:
  This post-market clinical follow-up study is a noninterventional, prospective, open-label, multi-center, non-controlled, non-randomized, observational study of patients transfused with pathogen reduced platelet and/or plasma components treated with the amotosalen/UVA technology (hereafter referred to as INTERCEPT Platelets and/or INTERCEPT Plasmas). Data on use of and patient outcomes associated with the use of all INTERCEPT Platelet and/or INTERCEPT Plasma components under surveillance at each site will be collected prospectively. Participating facilities will provide transfusion services and monitor transfusions based on routine standards of care and procedures. Investigators will provide data on all transfusion reactions (TRs) occurring within the first 24 hours of each INTERCEPT transfusion, and all Serious Transfusion Reactions (STRs) occurring up to 7 days after each INTERCEPT transfusion (safety monitoring period). Transfusion Reaction is defined as an adverse event that is “possibly, probably (likely), or certainly (definitely)” related to an INTERCEPT transfusion. The number of non-INTERCEPT components transfused to enrolled patients within 24 hours of a TR will also be recorded. Any TRs that are related to non-INTERCEPT components will be documented as “excluded” or “unlikely (doubtful)” in association with the INTERCEPT component. No additional data will be collected on non-INTERCEPT components.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Cerus Corporation

ecizinisce Universität Graz Graz, Austria, Instytutem Hematologii i Transfuzjologii Warsaw, Poland

Study timelines

Date when funding contract was signed

Planned: 14/11/2019

Actual: 14/11/2019

Study start date

Planned: 01/12/2019

Actual: 01/12/2019

Date of final study report

Planned: 01/12/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Cerus Corporation

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

CLI-HV 00138