415 Clinical Trials for Various Conditions
The goal of this study is to determine if there is a positive effect of prophylactic red blood cell (RBC) transfusion of leukoreduced, ABO, Rh (D/Cc/Ee) and Kell matched blood compared to standard of care on the number of episodes of acute sickle cell disease (SCD) manifestations or pregnancy-related complications requiring acute health care encounters (acute care/ER/Hospital visits) or resulting in death over the entirety of pregnancy until 2 months post-partum in women with SCD. RBC transfusion is the only disease-modifying therapy for pregnant women with SCD, and it is considered a standard treatment option however, there exists no consensus on the role of transfusion therapy in preventing SCD-related pregnancy complications. Participants will be randomly assigned to repeated red blood cell transfusions or the standard of care. Participants will be on study for about 8-10 months (Pregnancy through 2 months post-partum).
Sickle Cell Disease, Pregnancy Related
The purpose of this research study is to look at genes and determine how they interact with each other to find changes that could explain why some people's immune systems may respond to blood transfusions. This response is called an alloimmune response. We strongly believe that when someone has an alloimmune response, it is caused by changes in their genes. We plan to compare changes in the genes of individuals that develop red blood cell alloimmunization after blood transfusions with those that do not develop alloimmunization. This may help us to create more targeted therapeutic interventions, which may improve the health of alloimmune responders.
Sickle Cell Disease
The goal of this clinical trial is to compare two methods of labeling red blood cells with biotin. The main question to answer is whether red blood cells labeled 48 hours before transfusion survive as long as red blood cells labeled 6 hours before transfusion. Secondary questions are to measure the quality of the red blood cells and whether or not the biotin-labeled red blood cells induce antibodies in transfusion recipients. This study participant will have six study visits: 1. Screening visit, collect 35 ml blood, about 3 tablespoons 2. Donate 500 ml blood 3. Receive 20 ml of biotin labeled blood transfusion, collect 40 ml blood, about 3 tablespoons 4. Return 1 day after transfusion for blood draw (25 ml, about 2 tablespoons) 5. Return 30 days after transfusion for blood draw (25 ml, about 2 tablespoons) 6. Return 90 days after transfusion for blood draw (25 ml, about 2 tablespoons)
Measuring Red Blood Cell Survival After Transfusion
This clinical trial evaluates the effects of hemoglobin threshold-specific packed red blood cell (PRBC) transfusions on quality of life and functional outcomes in patients who have undergone chemotherapy or an allogeneic hematopoietic stem cell transplant for a high-grade myeloid neoplasm, acute myeloid leukemia, or B acute lymphoblastic lymphoma/leukemia. Some types of chemotherapy and stem cell transplants can induce low platelet counts and/or anemia that requires PRBC transfusions. Given critical shortages in blood supply, and risks associated with transfusion of PRBC, there has been much investigation into the "minimum" hemoglobin level that effectively balances safety and toxicity in patients. This clinical trial evaluates the effects of giving PRBC transfusions based on a more restrictive hemoglobin threshold (\> 7 gm/dL) compared to a more liberal hemoglobin threshold (\> 9 gm/dL) on quality of life and functional outcomes. A more restrictive threshold may be just as effective at maintaining patient quality of life and function while decreasing side effects from blood transfusions and helping to conserve blood supply resources.
Acute Myeloid Leukemia, B Acute Lymphoblastic Leukemia, B Lymphoblastic Lymphoma, Myeloid Neoplasm
Combat and civilian trauma frequently result in open wounds that are at risk for infection. Data from the Department of Defense Trauma Registry demonstrate that 74% of combat trauma casualties have an open wound. The Committee on Tactical Combat Casualty Care, the Prolonged Field Care Working Group, and the Joint Trauma System clinical practice guidelines recommend antibiotic prophylaxis for open wounds after trauma. The civilian setting has similar risks of open wound infection after trauma. In parallel, current practice guidelines recommend the aggressive use of balanced blood products during resuscitation. It remains unclear how the replacement of blood after hemorrhage through transfusion may affect antibiotic concentrations. Data is necessary to better understand this relationship to enhance wound prophylaxis antibiotic dosing, particularly in severely wounded casualties who receive blood products during massive transfusions. It remains unclear how these resuscitation methods may alter pharmacokinetics. The investigators hypothesize that drug concentrations decrease in direct relation to the amount of blood transfused during low-volume, massive, and supermassive transfusion after trauma compared to patients who receive no blood products. The investigators seek to understand the relationship between drug concentrations and blood product administration using a non-compartmentalized model in the setting of hemorrhage. Specifically, they will (1) obtain drug concentrations at regular intervals during the first 12-18 hours after administration of antibiotics, (2) determine how much blood products and fluids are transfused during the 12 hours prior to antibiotic and 24 hours post-administration, and (3) perform data modeling to understand the relationship between blood transfusions and drug concentrations to inform data-driven dosing models. Liquid chromatography methods will be developed to measure drug concentrations. The investigators will conduct a prospective, multicenter study at two large trauma centers - Brooke Army Medical Center and the University of Colorado Hospital. They will seek to enroll any participant who is hospitalized or anticipated hospital admission for acute trauma and receives an antibiotic on the study list during their index hospitalization. They will then model the drug levels against the amount of blood and fluid infused to create an understanding of the pharmacokinetics of antibiotic wound prophylaxis.
Adverse Effects in the Therapeutic Use of Other and Unspecified Agents Affecting Blood Constituents
The purpose of this pilot interventional study is to collect preliminary data on administering packed red blood cell (PRBC) during cardiac arrest (CA). The primary objective is to assess the feasibility of PRBC transfusion during cardiac CA to help optimize the methods required to augment cerebral and other vital organ oxygen delivery during cardiopulmonary resuscitation (CPR). The secondary objectives are to assess the effect of PRBC transfusion during prolonged cardiac arrests on cerebral oxygenation, end tidal carbon dioxide (ETCO2), return of spontaneous circulation (ROSC), survival to discharge, biomarkers of neural injury and inflammation, and neurological outcomes at hospital discharge, 30 days post-CA, and 90 days post-CA.
Cardiac Arrest
The strategy of the CoBAnK study is to establish and enable the function of Community-Facility Transfusion Committees (CFTCs) incorporating diverse representation involving hospital, community, and county leadership, to improve blood availability and transfusion at the point-of-care.
Blood Transfusion
The purpose of the study is to compare the efficacy and safety of Luspatercept vs epoetin alfa in the treatment of anemia in adults due to IPSS-R very low, low, intermediate-risk MDS in ESA-naïve participants who are non-transfusion dependent (NTD).
Myelodysplastic Syndromes
This clinical trial tests the the feasibility of testing a red blood cell transfusion threshold for improved quality of life for patients undergoing a pancreatectomy for pancreatic cancer. Pancreatectomy can be associated with significant blood loss. Blood loss can result in clinically important anemia causing fatigue. Pancreatic cancer itself can be associated with malnutrition and fatigue. Having a red blood cell transfusion threshold that results in a more liberal use of transfusions may improve quality of life for patients undergoing a pancreatectomy for pancreatic cancer.
Resectable Pancreatic Carcinoma
The purpose of this study is to evaluate the effectiveness of small phlebotomy tubes to reduce RBC transfusions in medical intensive care unit (ICU) and Intermediate care unit (IMU) patients with low hemoglobin compared with standard size tubes, to compare the intervention and the control groups in regards to: ICU length of stay (LOS), ICU mortality, hospital LOS, and hospital mortality and to assess the acceptability of small phlebotomy tubes in adult ICU and IMU patients.
Anemia
Open-label randomized controlled trial to test the effectiveness of whole blood transfusion for improving survival in children with severe malaria complicated by thrombocytopenia.
Severe Malaria, Thrombocytopenia
Determine whether clinical decision support (best practice advisory) improves provider adherence to transfusion guidelines for all four major blood components (red blood cells, plasma, platelets, and cryoprecipitate) using a randomized study design to reduce risk of bias. Alerts will be visible to the experimental ordering provider group, while they will not be visible to the control. Both groups still have access to information about best practices: local clinical transfusion guidelines are available and education on blood transfusion best practices will continue regardless of randomization assignment.
Anemia, Thrombocytopenia, Coagulopathy, Mild, Hypofibrinogenemia
TITRE - Trial of Indication-based Transfusion of Red Blood Cells in ECMO, is a multicenter, prospective, randomized clinical trial. The overarching goal of TITRE is to determine whether restricting red blood cell (RBC) transfusion according to an indication-based strategy for those with bleeding and/or deficit of tissue oxygen delivery, compared with transfusion based on center-specific hemoglobin or hematocrit thresholds, can reduce organ dysfunction and improve later neurodevelopment in critically ill children receiving Extracorporeal Membrane Oxygenation (ECMO) support.
Extracorporeal Membrane Oxygenation, Red Blood Cell Transfusion, Organ Failure, Multiple
Red Blood Cell - IMProving trAnsfusions for Chronically Transfused recipients (RBC-IMPACT) is an observational cohort study to assess donor, component, and recipient factors that contribute to RBC efficacy in chronically and episodically transfused patients. The objective of the study is to determine how specific genetic and non-genetic factors in donors and recipients may impact RBC survival after transfusion - in short, what factors on both the donor and recipient side may improve the efficacy of the transfusion.
Sickle Cell Disease, Thalassemia, Pediatric Cancer
Adult male patients brought to the emergency department as Level A trauma activations who are receiving emergency blood transfusion. Objectives 1. Evaluate PRBC equivalents transfused in each group in the first 24 hours (Primary outcome) 2. Evaluate total transfusion in each group in the first 24 hours (Secondary Outcome) including breakdown by FFP equivalents, platelet units, and cryoprecipitate 3. Evaluate 6 hour, 24 hour, and hospital mortality (Secondary Outcome) 4. Evaluate ICU outcomes in each group
Hemorrhagic Shock, Acute Blood Loss Anemia, Traumatic Brain Injury
The purpose of this study is to determine if burn injured patients who receive blood transfusions in the operating room have better outcomes when given transfusions at a set ratio (1:1)of PRBC to FFP. Traditionally, patients that need blood transfusions during surgery are given mostly packed red blood cells (PRBC) and some fresh frozen plasma (FFP). This is usually about 1:4 ratio of FFP to PRBC. In this study, we will compare this traditional approach (1:4) to a 1:1 ratio of FFP to PRBC during the operative period. The hypothesis of the study is that the use of FFP/PRBC ratio of 1:1, compared to a ratio of 1:4 will result in a(n) 1. decrease in the amount of blood transfused in the operating room 2. decrease in the amount of blood transfused during hospitalization 3. improvement in coagulation parameters (PT/PTT, INR, antithrombin III, Protein C and Fibrinogen in the operative period (from operation start to 12 hours post operatively) and at 24 hours postoperatively 4. decrease the hospital length of stay, lung dysfunction, infections, and mortality
Burn Injury
The Reduction of Allogenic Blood Transfusion in Locally Advanced Kidney Cancer Trial (RESTRICT). The primary objective is to reduce the number of units of allogenic blood transfusion in locally advanced kidney cancer (≥ cT2). Secondary objectives include reduction in perioperative complications, assessment of recurrence free-survival and improving overall survival.
Kidney Cancer
This study is a randomized controlled trial in which hospitalized patients with anemia are randomized to receive transfusion at: a) Hb\<9g/dL (liberal transfusion strategy), or b) Hb\<7g/dL (restrictive transfusion strategy). We are measuring self-reported fatigability, fatigue, and activity levels at randomization and 7 days post hospital discharge in both trial arms. In a subset of 75 patients in each trial arm (150 total), we will are administering the 6 Minute Walk Test at randomization and 7 days post discharge.
Anemia, Red Blood Cell Transfusion, Fatigability, Fatigue, Physical Function
Blood Banks of large medical centers have large annual budgets, typically millions of dollars. Blood product wastage results in not only in a loss of the product's cost, but also of the fees involved in transporting, handling, and administering these products. Optimal utilization of blood products requires a balance between maximizing patient clinical outcomes while avoiding unnecessary costs and risks associated with transfusions. This project will specifically focus on packed red blood cell transfusions (pRBCs). There are clear guidelines for transfusing pRBCs however these guidelines are not always followed. pRBC transfusions outside of recommended guidelines is associated with increased risk of harm to patients. Our aim is to improve adherence to guideline indicated pRBC transfusions for patient in the UCHealth system thereby decreasing inappropriate (non-guideline indicated) pRBC transfusions. We will conduct a QI project seeking to improve pRBC transfusion guideline adherence. This project will involve data review to establish baseline rates, multimodal interventions to improve adherence to pRBC transfusion guidelines including provider education, modifications to the electronic ordering interface, and changing blood back policies at participating institutions.
Blood Transfusion
The purpose of this Phase 3 study is to evaluate the efficacy and safety of Luspatercept compared with placebo in subjects with myeloproliferative neoplasm (MPN)-associated Myelofibrosis (MF) and anemia on concomitant Janus kinase 2 (JAK2) inhibitor therapy and who require red blood cell count (RBC) transfusions. The study is divided into Screening Period, a Treatment Phase (consisting of a Blinded Core Treatment Period, a Day 169 Response Assessment, a Blinded Extension Treatment Period, and an Open-label Extension Treatment Period), and a Posttreatment Follow-up Period. Following the Day 169 Response Assessment, subjects who did not show clinical benefit will have the option to unblind. Subjects who were on placebo during the Blinded Core Treatment Period will have the opportunity to crossover into the Open-Label Extension Treatment Period and receive Luspatercept.
Myeloproliferative Disorders, Myelofibrosis, Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, Anemia
The primary aim of this observational registry is to study the outcomes of patients with hemorrhagic shock transported by Boston MedFlight receiving blood products during transport.
Hemorrhagic Shock
This study seeks to utilize an innovative approach of a single session problem-solving intervention to address psychosocial factors affecting patient outcomes within the pediatric sickle cell population. The study will be a randomized control trial of a single session problem-solving intervention. This original research will investigate the feasibility and efficacy of utilizing a single-session problem-solving intervention to address problems affecting children and families receiving chronic blood transfusions for sickle cell disease in order to: 1) contribute to literature related to single session problem solving interventions with the chronic transfusion sickle cell population and 2) identify a model of sustainable care that reduces the burden of a multiple session intervention and increases access to services. Additionally, this research aims to provide relatively low burden and potentially highly effective intervention into regular care for this population in order to evaluate the feasibility of integrating a single-session problem solving intervention into routine clinical flow, thereby addressing needs more systematically that have been identified by families. Further, this research aims to identify potential utility of medical providers being trained on providing the intervention, which could be part of a future study.
Sickle Cell Disease
The purpose of this pilot research study is to evaluate the effectiveness of blood and platelet transfusions in improving symptoms and quality of life of patients enrolled in hospice.
Hematologic Malignancy
This is a randomized double-blind control trial evaluating the use Tranexamic acid (TXA) to decrease blood loss and transfusion requirements in pediatric and young adult cancer patients undergoing a limb salvage procedure that frequently requires perioperative or post-operative transfusions of blood products. Primary Objective * To evaluate the difference in intra-or post-operatively transfused blood volume (mL/kg) for patients undergoing limb salvage procedures of the distal femur or proximal tibia who are randomized to receive perioperative tranexamic acid (TXA) versus placebo. Secondary Objectives * To evaluate changes in platelets and in hemoglobin from pre-op to post-op level for patients randomized to receive perioperative TXA versus placebo. * To evaluate differences in post-operative daily surgical drain output for patients randomized to receive perioperative TXA versus placebo. * To evaluate changes in estimated blood loss (EBL) for patients randomized to receive perioperative TXA versus placebo. * To evaluate the association between the intra-or post-operatively transfused blood volume and estimated blood loss (EBL) for patients randomized to receive perioperative TXA and placebo, respectively. Exploratory Objectives * To evaluate differences in functional outcomes post-operatively for patients randomized to receive perioperative TXA versus placebo. * To explore if significant correlations are observed between parameters reported with rotational thromboelastometry (ROTEM®) and EBL and transfusion requirements in pediatric and young adult patients undergoing limb salvage procedure who are randomized to perioperative TXA versus placebo. * To evaluate differences in the prevalence and management of wound complications such as superficial or periprosthetic infections, wound dehiscence, contact dermatitis, post- operative hematomas, or any other clinically significant wound complication between patients randomized to receive perioperative TXA versus placebo.
Cancer of the Bone, Limb Salvage
We will study 40 matched patients. 20 patients will receive leukoreduced whole blood from the solid organ donor. These 20 patients will be compared to 20 historical matched controls with regards to allogenic blood product usage and other physiologic markers
Transfusion Related Complication, Liver Transplant
The primary purpose of this observational study was to determine if pRBC transfusions decrease the frequency of intermittent hypoxia events in very low birth weight infants (VLBW) during the first six weeks of life. The impact on non-pRBC transfusions on the frequency of intermittent hypoxia was also assessed.
Hypoxia Neonatal, Premature, Blood Transfusion
This proposal is an investigator-initiated, single-site proof of concept trial. Five patients will undergo isovolemic hemodilution-red cell exchange (IHD- RBCx) with up to 10 units of red cell antigens (Rh group, Kell, Duffy, Kidd blood group antigens) matched normal donor red cells to replace a target of 70% of the patient's red cells with donor red cells. The procedure will be performed as an outpatient according to protocols established for sickle cell anemia patients. One of the investigators is an expert on RBCx and will oversee the transfusion. Subjects will be assessed before and after transfusion, and at two months post transfusion. Outcome measures include neurological exam, electroencephalography (EEG), neuropsychological testing, and biochemical assays.
Glucose Transporter Type 1 Deficiency Syndrome, GLUT1DS1
The Purpose of the study is to test the hypothesis that administration of an S-nitrosylating (SNO) agent can improve tissue oxygenation during transfusion of packed red blood cells (RBCs).
Transfusion Related Complication
As tranexamic acid (TXA) becomes more prevalent, all patients are receiving the same dose and method of delivery regardless of their pre-operative risk of transfusion. Therefore, the aim of the study is to determine whether or not repeated dosing of oral or different method of delivery like intravenous (IV) TXA reduces the postoperative reduction in hemoglobin, hematocrit, number of transfusions, and postoperative blood loss following open spine surgery. The regimen that utilizes multiple doses of oral TXA will significantly minimize post-operative blood loss and transfusion requirements compared to the use of a single dose regimen. Furthermore, oral TXA will be as efficacious as intravenous delivery of TXA.
Open Posterior Thoracolumbar Spinal Fusion Procedure
The Investigators hypothesize that older red cell units trigger phagocytosis and activation of circulating macrophages with a downstream immunomodulatory cascade and release of excess Non Transferrin Bound Iron(NTBI) that leads to increased rates of infection in adults with Sickle Cell Disease(SCD). To test this hypothesis, the study staff will perform a randomized prospective clinical trial. In aim 1, the study staff will determine the biochemical differences between ≥30 day-old versus ≤10 day-old units. In aim 2, the study staff will determine the physiologic effects of the transfused blood in a patient with SCD. Lastly, in aim 3, the study staff will explore the clinical implications of receiving older red cells over a 3 month period.
Sickle Cell Disease