At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 581 enrolled
Drug / intervention
INTERCEPT +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients Undergoing Complex Cardiac Surgery Procedures
In Brief
A Phase 3 clinical trial evaluating INTERCEPT and Control for Anemia. Completed, enrolled 581 participants across 18 sites.
Detailed Summary
The objective of this study is to evaluate the efficacy and safety of RBC transfusion for support of acute anemia in cardiovascular surgery patients based on the clinical outcome of renal impairment following transfusion of red blood cells (RBCs) treated with the INTERCEPT Blood System (IBS) for Red Blood Cells compared to patients transfused with conventional RBCs.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnemia
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedMar 2018
Enrollment StartDec 2018
Primary CompletionDec 2023
Study CompletionMar 2024
TodayJul 2026
First PostedMar 8, 2018
Enrollment StartDec 5, 2018
Primary CompletionDec 4, 2023
Study CompletionMar 5, 2024
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 8.3 years ago
Interventions
INTERCEPTdevice
Pathogen reduced RBCs
Controldevice
Conventional RBCs