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
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
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
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)
N/A N=310 Evaluation of Trima Version 7.0 Platelets in 100% Plasma
Healthy Volunteers
Primary: Number of Participants With Platelet Units Containing an Acceptable Residual WBC Level — 92; 93; 93; 1 Participants
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
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
N/A N=335 Evaluation of Trima Version 7.0 Platelets in PAS
Healthy Volunteers
Primary: Number of Participants With Platelet Units Containing an Acceptable Residual WBC Level — 93; 93; 93; 0 Participants
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
Phase 2 N=40 Preventing Stem Cell Transplant Complications With a Blood Separator Machine
MDS (Myelodysplastic Syndrome) · Myeloproliferative Disorder · Lymphoma, Non-Hodgkin
Primary: Overall Survival — 36 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=43 Data Collection of Routine Clinical Use With the Spectra Optia® Apheresis System for White Blood Cell Depletion
Leukocytosis
Primary: Percent Decrease in White Blood Cell Count in Patient Following Apheresis Procedure — 54.5 % change in subject's WBC count
N/A N=70 Evaluation of the Spectra Optia® Apheresis System Mononuclear Cell (MNC) Collection Procedure in Healthy Blood Donors
Leukapheresis
Primary: Mononuclear Cell Collection Efficiency — 61; 57 % of processed MNCs that were collected
Phase 4 N=280 Immunomodulation Following Transfusion
Blood Component Transfusion
Primary: Number of Participants With Changes in the Production of Antibody to HLA Antigens — 2; 6; 2; 5 Participants
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 2 N=77 Selective Depletion of CD45RA+ T Cells From Allogeneic Peripheral Blood Stem Cell Grafts From HLA-Matched Related and Unrelated Donors in Preventing GVHD
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive · Acute Biphenotypic Leukemia · Acute Leukemia of Ambiguous Lineage
Primary: Chronic GVHD — 17; 20; 14; 17 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
Phase 2 N=31 Stem Cell Transplantation for Patients With Cancers of the Blood
CML (Chronic Myelogenous Leukemia) · CLL (Chronic Lymphocytic Leukemia) · AML (Acute Myelogenous Leukemia)
Primary: To Determine if Selective T Cell Depletion Using the Photodepletion Procedure Can Substantially Reduce the Rate of Severe Acute GVHD (Grade III/IV) After Matched Sibling…
Phase 2 N=25 Selective T-Cell Depletion to Reduce GVHD (Patients) Receiving Stem Cell Tx to Treat Leukemia, Lymphoma or MDS
Graft vs Host Disease · Myelodysplastic Syndromes · Leukemia
Primary: Treatment-related Mortality — 4.5 percentage of participants
N/A N=162 Washed Versus Standard Blood Cell Transfusions in Pediatric Open Heart Surgery
Congenital Heart Disease
Primary: 12 Hour Plasma Interleukin (IL)-6 to IL-10 Ratio — 8.9; 3.8 ratio
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
Phase 2 N=20 Selective Depletion of CD45RA+ T Cells From Allogeneic Peripheral Blood Stem Cell Grafts in Preventing GVHD in Children
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive · Acute Biphenotypic Leukemia · Acute Leukemia of Ambiguous Lineage
Primary: Graft Failure — 0; 1 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
Phase 2 N=116 Methods to Enhance the Safety and Effectiveness of Stem Cell Transplants
Chronic Myelogenous Leukemia · Acute Myelogenous Leukemia · Chronic Lymphocytic Leukemia
Primary: Survival and Non-relapse Mortality at Day +200 Using the Miltenyi Reagent System — 43; 4 participants
N/A N=23 An Evaluation of the Spectra Optia CMNC Collection Procedure
Healthy Apheresis Donors · Mononuclear (MNC) Cell Donors
Primary: CD34+ Collection Efficiency (CE1 %) — 87.7; 81.4; 66.6; 65.8 percent
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
N/A N=77 Clinical Evaluation of the CM-1500 During Apheresis Blood Donation
Fluid Loss
Primary: Characterize Changes in the Relative Index During an Apheresis Procedure — 94.9; 99.3 Relative Index
N/A N=128 Trima Accel® System Post Count Algorithm Study
Healthy Volunteers
Primary: Donor Postprocedure Platelet Count Following Donation of Single Platelet Product — 60; 60; 0; 0 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=192 Impact of Fluid Restriction Policy in Reducing the Use of Red Cells in Cardiac Surgery
Coronary Artery Disease · Coronary Artery Bypass · Erythrocyte Transfusion
Primary: Mean Number of Packed Red Cells Units Transfused During Hospital Stay — 1.13; 1.91 packed red cells units — p=<0.05
N/A N=351 Evaluation of Physiological Variables and Detection of Blood Loss Using the Zynex Fluid Monitoring System, Model CM-1600
Fluid Loss
Primary: Change in the Relative Index (RI) After Minor Blood Loss (e.g., 500mL) — 2.9 Percent change in RI