Phase 1 N=29 Inactivation of Whole Blood With Mirasol
Focus of Study: Radiolabel Recovery and Survival of RBCs
Primary: Red Blood Cell (RBC) 24-Hour Recovery — 82.51; 91.70 % 24-hour RBC Recovery
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Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 2 N=15 In Vivo Study to Assess the Recovery and Survival of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for up to 7 Days
Healthy
Primary: Post Infusion Recovery of Test Platelets at End of Storage (Day 7) — 39.5; 57.8; 39.1; 60.4 percentage of infused platelets
Phase 2 N=104 Red Blood Cell (RBC) Survival Following Transfusion in Infants
Neonatal Anemia
Primary: Number of Discrete Biotinylated RBC Densities (up to 5 Discrete Densities) That Can be Accurately Measured by Flow Cytometry, i.e., Without Overlap. — 5; 5 flow…
N/A N=30 Trima Non-DEHP Leukoreduced Red Blood Cell In Vivo Recovery Study
Device Validation of In-vivo Performance
Primary: Number of Participants With Success of RBCs in Vivo Recovery After 42-day Storage (Single-label Method) — 24 Participants
N/A N=22 Survival and Recovery of Radio-labeled Platelets Derived From Mirasol-treated Whole Blood
Blood Safety
Primary: Platelet 24-hour Relative Recovery — 43.31; 52.01 Percentage of platelet count
N/A N=33 An In Vivo 24-Hour Recovery Study of Whole Blood by the Reveos System
Device Validation of In-vivo Performance
Primary: Number of Participants With Success of RBC's in Vivo Recovery After 42-day Storage — 23 Participants
Phase 1 N=5 Transfusion of Biotinylated Red Blood Cells
Anemia
Primary: Number of Participants That Had bRBC Detectable at 70 Days Post-intervention — 5 participants
N/A N=79 Donor Iron Deficiency Study - Red Blood Cells From Iron-deficient Donors: Recovery and Storage Quality
Iron Deficiency
Primary: 51-Chromium 24-hour Post-transfusion RBC Recovery of Units — 1.6; -0.4 percentage change
N/A N=254 Frozen Red Blood Cell Transfusions in Trauma Patients
Blood Loss · Anemia · Trauma
Primary: Tissue Oxygenation — 100.3; 98.2; 98.3 percentage of baseline
N/A N=32 In Vivo Recovery and Survival Study of Platelets Collected on Trima Accel System and Stored in InterSol Solution
Healthy Volunteers
Primary: Recovered Percentage of the Extrapolated Platelet Count at Time 0 — 45.15; 56.02 percent of extrapolated platelet count
Phase 1 N=22 Biotin-RBC Transfusion in SCD
Sickle Cell Disease
Primary: Percentage of Biotin Labeled RBCs — 97.3; 80; 21 percentage of biotin-labeled RBCs
N/A N=60 Duration of Red Blood Cell Storage Prior to Transfusion
Iron, Blood Level Abnormal
Primary: Non-transferrin-bound Iron Level (AUC) — 0.5588; 2.839; 3.684; 5.272 microMole*hr/L
N/A N=3,835 Red Cell Storage Duration and Outcomes in Cardiac Surgery
Blood Transfusion · Cardiac Surgery
Primary: Primary Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to Postoperative Morbid Outcomes in Patients Undergoing Cardiac Surgery. — 360; 362…
Phase 4 N=42 VO2 Max: In Vivo Model for Functional Red Cell Testing. Can RECESS be Explained?
Healthy
Primary: Percent Change From Baseline in Maximal Oxygen Uptake (VO2 Max) After Blood Cell Transfusion — 10.5; 8.5; 10.9 percent change
N/A N=100 Use of Saline-Washed Platelet and Red Cell Transfusions in Adult Acute Leukemia
Leukemia, Myeloid, Acute · Leukemia, Lymphoblastic, Acute
Primary: Survial Rate at 30 Days — 100; 97 percentage of participants
Phase 4 N=4 Rejuvesol® Washed RBC in Sickle Cell Patients Requiring Frequent Transfusions
Sickle Cell Disease
Primary: Average Percent Hemoglobin (HbA) Decrement Per Day — 0.629; 0.659 %HbA per day — p=0.95
Phase 2 N=12 Quantitative Mass Transfer of SFP-iron From Dialysate to Blood in CKD-HD Patients
Kidney Failure
Primary: Net Iron Delivery From SFP Via the Dialysate — 692 microgram
Early Phase 1 N=22 Red Cell Half Life Determination in Patients With and Without Sickle Cell Disease
Sickle Cell Disease · Sickle Cell Anemia
Primary: Mean Red Blood Cells Lifespan in Participants — 64.1; 113.4; 126.0; 123.7 day — p=<0.001
Phase 2 N=100 Clinical Investigation to Evaluate the Hemanext® Oxygen Reduction System - Pivotal Trial
Whole Blood Donation and Leukoreduction
Primary: % of Red Blood Cells With Hemolysis — 0.29; 0.29 % of Red Blood Cells with Hemolysis
Phase 2 N=171 Point-of-Care RBC Washing to Prevent Transfusion-Related Pulmonary Complications
Blood Transfusion Complications
Primary: Biomarkers Associated With Transfusion-Related Acute Lung Injury and Transfusion Associated Circulatory Overload. — 101; 105; 12; 15 units on a scale (pg/ml)
Phase 3 N=108 A Study for Leukemia Patients With Life-Threatening Infections
Leukemia
Primary: Number of Participants Alive at Day 30 — 31; 39 Participants
Phase 3 N=1,481 Red Cell Storage Duration Study
Cardiac Surgery · Erythrocyte Transfusion
Primary: The Change in the Composite Multiple Organ Dysfunction Score (MODS) From the Pre-operative Baseline. The Worst Post-operative Values of Each Component of MODS Will be…
Phase 1 N=59 Study of Radiolabeled Monoclonal Antibody Anti-B1 for the Treatment of B-Cell Lymphomas and Extended Study to Determine the Safety and Efficacy of Coulter Clone® 131Iodine-B1 Radioimmunotherapy of Advanced Non-Hodgkin's Lymphoma
Lymphoma, Non-Hodgkin
Primary: Number of Participants (Par.) During Initial Treatment Exposed to the Indicated Dose Levels of the Therapeutic Dose (TD), Re-dose, and Total Dose (TD + Re-dose) — 6; 1…
N/A N=177 Microparticles in Stored RBC as Potential Mediators of Transfusion Complications
Coronary Artery Bypass
Primary: In Hospital Mortality — 0; 4 participants — p=0.142
Phase 1 N=170 Evaluation of Whole Blood With CPD Anticoagulant and AS-7/SOLX Additive Solution
Blood Donors
Primary: Red Blood Cell Post-filtration Recovery — 92.57; 92.70; 90.96; 90.23 % recovery at day 0
N/A N=722 Balancing Risk: Red Blood Cell Transfusion Strategies In Cardiac Surgery
Anemia
Primary: A Composite of In-hospital Postoperative Morbidity and Mortality — 59; 68 Participants
Phase 3 N=26 Age of Blood in Sickle Cell Transfusion
Sickle Cell Disease
Primary: Proportion of Biochemically Old Red Cell Units — 0.71; 0.86 proportion biologically old units — p=0.051
N/A N=10 Volume Kinetics for Starch Solution and Acetated Ringers
Blood Volume · Blood Coagulation
Primary: Volume Effects for Hydroxyethyl Starch, Ringer's Solution or a Combination of Both. — 5.53; 2.94; 3.12; 4 Litre
Phase 3 N=581 Study to Evaluate the Efficacy & Safety of the INTERCEPT Blood System for RBCs in Complex Cardiac Surgery Patients
Anemia
Primary: Percentage of Patients Who Have Received at Least One Study Transfusion With a Diagnosis of Renal Impairment Defined as: — 46; 45 Participants
N/A N=32 Evaluation of the Spectra Optia® Mononuclear Cell Collection Procedure
Multiple Myeloma
Primary: Days Until Neutrophil Recovery Following Peripheral Blood Stem Cell Transplant Minus the Historical Median Day Until Recovery. — 0 Days — p=<0.025