INTERCEPT Blood System for RBCs Study in Regions at Potential Risk for Zika Virus Transfusion-Transmitted Infections

PHASE3RecruitingINTERVENTIONAL
Enrollment

800

Participants

Timeline

Start Date

May 11, 2017

Primary Completion Date

October 31, 2025

Study Completion Date

January 30, 2026

Conditions
Anemia
Interventions
DEVICE

INTERCEPT Blood System for Red Blood Cells

The pathogen reduction process begins with a unit of RBCs derived from whole blood that is separated according to local regulations and standard operating procedures at the Blood Centers. RBCs are suspended in AS-5 or SAG-M for non-US sites. Leukocyte-reduction of whole blood or RBCs will be performed per manufacturer's instructions. The INTERCEPT Blood System process is performed on a single unit of leukocyte-depleted RBC in AS-5.

DEVICE

Conventional (Control)

Conventional RBC components ordered and administered to study patients by their treating physicians according to the local standards of care

Trial Locations (12)

23298

ACTIVE_NOT_RECRUITING

Virginia Commonwealth University, Richmond

30303

RECRUITING

Grady Health System, Atlanta

30316

RECRUITING

CHOA (Children's Healthcare of Atlanta), Atlanta

32224

ACTIVE_NOT_RECRUITING

Mayo Clinic Jacksonville, Jacksonville

75390

RECRUITING

UT Southwestern Medical Center, Dallas

77303

RECRUITING

Baylor St. Luke's Medical Center, Houston

85016

RECRUITING

Phoenix Children's Hospital (PCH), Phoenix

89135

RECRUITING

C4TKs (Cure 4 The Kids), Las Vegas

06520

ACTIVE_NOT_RECRUITING

Yale University, New Haven

00705

ACTIVE_NOT_RECRUITING

Menonita General Hospital, Aibonito

00725

ACTIVE_NOT_RECRUITING

HIMA San Pablo Hospital, Caguas

ACTIVE_NOT_RECRUITING

San Juan Bautista School of Medicine Clinical Research Unit, Caguas

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Cerus Corporation

INDUSTRY