39 Clinical Trials for Various Conditions
The objective of the NeoPlaTT trial is to test whether, among extremely preterm infants born at 23 0/7 to 26 6/7 weeks' gestation, a lower platelet transfusion threshold, compared to a higher threshold, improves survival without major or severe bleeding up to 40 0/7 weeks' postmenstrual age (PMA).
This is a prospective randomized clinical trial designed to determine the hemostatic ability of pathogen reduced platelet, when compared to non-pathogen reduced platelets suspended in platelet additive solution.
The aim of this study is to see if administering platelets (cells in our blood that stop or prevent bleeding) results in improved platelet function and slows/stops the progression of a head bleed for patients who have a traumatic head bleed and are on antiplatelet therapy (medications that stop blood cells from forming a blood clot) prior to admission.
Some of the treatments for cancer can cause platelets (the part of the blood that helps with clotting) to decrease. If they are too low, then clinicians may recommend a transfusion (getting platelets from another person added to someone else's body). This usually works to increase the person's platelets to a healthy level, but sometimes it doesn't work. This is called platelet refractoriness. This study is trying to find out whether isatuximab (the study drug) may help people with a certain type of platelet refractoriness by removing some cells in order to make platelet transfusions more effective.
This study is to determine the effectiveness of a computerized clinical decision support tool (Best Practice Alert - BPA) in reducing unnecessary platelet transfusions based on guidelines published by national transfusion societies such as the AABB (formerly American Association of Blood Banks).
This is a prospective observational study that was designed with the following two Specific Aims: 1. To determine whether the Immature Platelet Fraction percentage (IPF%) and the Immature Platelet Count (IPC) are better predictors of bleeding than the platelet count alone in neonates of different gestational and post-conceptional ages and with different etiologies of thrombocytopenia; and 2. To characterize the effects of neonatal thrombocytopenia and platelet transfusions (PLT Tx) on bleeding and on markers of systemic inflammation, thrombosis, and neutrophil extracellular traps (NET) formation in neonates with different underlying conditions.
This pilot clinical trial compares the safety of two different platelet transfusion "thresholds" among patients with blood cancer or treatment-induced thrombocytopenia whose condition requires anticoagulant medication (blood thinners) for blood clots. Giving relatively fewer platelet transfusions may reduce the side effects of frequent platelet transfusions without leading to undue bleeding.
Sepsis is life-threatening and dysregulated response to infection that results in endothelial activation and dysfunction that leads to systemic microvascular leak and multiple-organ failure. This study will identify patients that have sepsis with thrombocytopenia and randomize them to receive a unit of platelets or an equivalent volume of saline.
Hypothesis: Dilutional thrombocytopenia after cardiopulmonary bypass (CPB) is universal and administration of donor apheresis platelets just prior to termination of bypass will assist in early correction of coagulopathy, early hemostasis and lesser donor exposure of blood products after cardiac surgery. Background: What is the Problem? - Bleeding, Transfusion and Outcomes 1. Excessive bleeding after neonatal cardiac surgery has been independently associated with increased adverse events, morbidity and mortality.1,2 Bleeding after neonatal open-heart surgery has multiple etiologies such as immaturity of the building blocks of coagulation, effects of deep hypothermia, longer CPB times, altered flow states and dilutional state induced by being on CPB leading to low platelet count, low platelet function, low fibrinogen levels, altered fibrinogen polymerization, complement activation, etc.2,3 The strongest predictor of transfusion after cardiopulmonary bypass in children was deemed to be the CPB circuit volume and the effect of hemodilution.4 2. The dilutional coagulopathy after neonatal CPB requires intense damage control resuscitation with massive transfusion of platelets, packed red blood cells (PRBC), cryoprecipitate, fresh frozen plasma (FFP) and supplemental factor concentrates. In a previous study at this institution (IRB# HSC-MS-13-0647), we have shown that in neonates undergoing open-heart surgery there was a significant drop in platelet counts after bypass (71% change, baseline= 268 ± 90, Post CPB= 76 ± 27, 109/L). Associated with this drop , the average intraoperative transfusion load in neonates undergoing cardiac surgery with CPB at our institution constitutes of PRBC= 63± 43 ml/kg, FFP=51± 21 ml/kg, cryoprecipitate =12+6 ml/kg, platelets = 28 +16 ml/kg and cell-saver =27± 10 ml/kg. In addition 72% of these patients were exposed to a 3-factor prothrombin complex concentrate (Bebulin®). Although this "throw the kitchen sink" approach is effective in achieving hemostasis, it comes with significant effects on post CPB hemodynamics, constantly changing hematocrit, variable blood volume with inability to achieve steady state inotropic state affecting cardiac output, oxygen delivery and adding to pulmonary hypertension. Overall, having higher platelet counts at the time of weaning from cardiopulmonary bypass has distinct advantages of reducing transfusions and improving outcomes.
Background: Platelets are blood cells that help blood clot. Some people have what is called thrombocytopenia. This means they have a low blood platelet count. They need platelet transfusions very often. Human leukocyte antigen (HLA) alloimmunization occurs for a lot of these people. They become refractory. This means their platelet levels no longer increase after transfusions. Researchers want to study a procedure that detects HLA antibodies. They want to test how well it predicts how a person will respond to a transfusion. They want to see if it does this better than the procedure that is usually used. Objective: To study the effect of C1q-binding of Class I HLA antibodies on platelet refractoriness in people who get platelet transfusions. To test if this method better predicts response to platelet transfusion than the IgG solid phase immunoassay method. Eligibility: People enrolled on protocols 11-C-0136, 08-H-0156, 03-C-0277, 01-C-0157, or 01-C-0129 who: Agreed to have their specimens and data used for future research Had Class I HLA antibodies detected by the IgG method Had one or more platelet transfusions at NIH after the first positive HLA IgG antibody result Design: For each participant, researchers will look at a small portion of their archived plasma sample. The samples were left over from prior HLA antibody tests. Participants samples will be analyzed. They will be tested to see if C1q-binding HLA antibodies are present. This will be done by solid phase immunoassay. Results will be compared with the past results of the IgG method. Participants data will be stored in database that s protected by password. ...
Background: - Platelets are tiny cells in the blood that help stop bleeding. Thrombocytopenia happens when people do not have enough normal platelets. Getting a transfusion of another person s platelets can help stop too much bleeding. But because these cells are from other people, the body may reject them,putting them at risk for serious bleeding complications. This conditions is called alloimmune platelet refractoriness . There are evidence that in many patients, platelet counts fail to increase after a platelet transfusion because the transfused platelets are destroyed by the body s defence soldier, called complement . Researchers want to see if a drug, that inhibits complement, can help increase platelet levels and reduce bleeding Objectives: - To see if eculizumab increases platelet levels more after a transfusion. To see if it reduces the chance of bleeding too much. Eligibility: - Adults 18-75 years old who have thrombocytopenia and alloimmune platelet refractoriness. Design: * Participants will be screened with medical history, physical exam, and blood tests. * Participants will have the procedures listed below. They can have them while they are in the hospital. Or they can go to the outpatient clinic for them. Each visit may take up to 3 hours. * Participants will get a meningitis vaccine if needed. Then they will get the study drug as an infusion. * Participants will have a platelet transfusion. Their blood will be drawn every 24 hours until the platelet count is less than 10,000 per 1 microliter of blood. * They will take antibiotics for 14 days. * Participants will have a checkup and blood drawn twice a week for 2 weeks. They will get more transfusions if needed.
The objective of this study is to determine if the administration of platelets will improve outcome in patients with ICH who are being treated with either aspirin, a thienopyridine (ticlodipine, clopidogrel, prasugrel) or a combination of both. The study has four specific aims: 1. To determine what affect platelet administration will have on bleeding in the brain. 2. To determine what affect platelet administration will have on brain function. Several assessments to test the functioning of the brain will be performed at enrollment and throughout the study. Comparing the results of these assessments between the experimental and control groups should allow us to determine if platelet administration improves outcomes in patients with bleeding in the brain exposed to antiplatelet therapy. 3. An important risk of reversing antiplatelet therapy is exposing the patient to the very complications this therapy was designed to prevent. Therefore, tracking complications will be a very important part of this study. The investigators will compare the rates of death, heart attack, stroke and clots in the veins between groups. 4. Some patients (10-40%) have limited responsiveness to antiplatelet therapy. While platelet responsiveness, as measured by a special platelet blood test, will not affect enrollment, the investigators feel it will be important to measure.
Study to see if platelet transfusion stop or lessen the effect of the drug on platelets
To evaluate changes in platelet counts and hemodynamics between "rapid" and "long" platelet infusion groups.
The purpose of this study is to assess the ability of eltrombopag to elevate platelet counts thereby reducing the need for platelet transfusions in chronic liver disease patients with thrombocytopenia undergoing elective invasive procedures. The clinical benefit of eltrombopag will be measured by the proportion of subjects who avoid platelet transfusions, before, during and up to 7 days after undergoing an invasive procedure. In addition, bleeding events will be monitored during this time. The number of transfusions, safety events and medical resource utilisation will be monitored during this time and for up to 30 days after undergoing an invasive procedure to help further evaluate clinical benefit.
Infants who have low platelets and who require a platelet transfusion are included in this study. Platelet transfusions are routinely given to infants when their platelet count falls below a certain level. The study will look at the amount of platelets transfused. The purpose of the study is to evaluate the effect of platelet transfusions on the level of a protein (thrombopoietin) which is known to help control platelet production.
This study will determine if transfusion of platelets containing HLA antibodies (certain antibodies to white blood cells) are more likely to cause transfusion reactions than transfusion of platelets that do not contain HLA antibodies. People 18 years of age or older who donate platelets at the NIH Clinical Center may be eligible for this study. An extra tube of blood (about one teaspoon) is obtained from participating donors at the time of their donation at the NIH Platelet Center. The blood plasma in the extra tube is tested for HLA antibodies and antibodies to certain white blood cells called granulocytes. The research sample is assigned a code number for identification and sent to the HLA Laboratory in the Department of Transfusion Medicine.
Background: Platelets are cell fragments in the blood that help it clot. Some people get very low platelet counts during a disease or treatment. Low platelet counts can cause severe bleeding. Some people are not helped by platelet transfusions at the standard transfusion rate. This is called platelet transfusion refractoriness (PTR). Researchers want to learn more about transfusing platelets so they can make transfusions more effective. Objectives: To study the effects of transfusing platelets more slowly than the standard rate. To obtain data to improve the effectiveness of platelet transfusions in people with PTR and decrease the risk of bleeding in some people. Eligibility: Adults ages 18-100 who have very low platelet counts requiring platelet transfusion, and have evidence of PTR Design: Participants will be screened with a review their recent NIH medical records. They will have blood drawn. Participants will have up to three 12-hour treatment blocks. They can have only one block per day. During each block, they will have 2 platelet transfusions in those 12 hours. One transfusion will take place over 1 hour (SHORT infusion). The other will take place over 4 hours (LONG infusion). Participants will be randomly put in 1 of 2 treatment groups. This will dictate whether they get the SHORT or LONG infusion first. Participants will have blood drawn: * When they enroll * Right before each transfusion * 2, 4, and 6 hours after each transfusion Each blood draw will consist of a complete blood count. Smaller tubes that require only small amounts of blood will be used to minimize the amount of blood drawn.
This is a platelet transfusion study. The purpose of this study is to measure the life span and quality of platelets stored in a refrigerator. Participants will give platelets by apheresis. Platelets will be stored for 3 -20 days. A small portion of the subject's own stored platelets will be tagged with a radioactive isotope and infused back into the participant. This will enable us to track how many transfused platelets survive after storage in the refrigerator.
The planned minimal risk study is a blinded study on consecutive transfusable platelet products. The aim of the study is to evaluate the quality of platelet components sampled prior to transfusion. The primary patient transfusion outcome in this study is the 1-hour corrected count increment (1 hr CCI), which is a widely accepted clinical outcome measure. Platelet products will be sampled for ThromboLUX testing before being sent from the blood bank to the treatment center. After receipt at the treatment center, the platelet products will be used as per regular clinical practice, and the outcome data from each patient will be collected. At the end of the study, TLX Scores will be compared to the transfusion outcomes to determine if a low TLX Score is associated with a poor transfusion outcome. During the course of the study, the TLX Score will not be known to the clinicians, or utilized in any way to decide if the platelet product should be transfused.
The study is being conducted to validate the clinical performance of the T-TAS 01 HD assay for measurement of thrombogenicity in patients with thrombocytopenia receiving a platelet transfusion.
Critically ill children supported by extracorporeal membrane oxygenation (ECMO) receive large volumes of prophylactic platelet transfusions to prevent bleeding. However, mounting evidence has demonstrated significant morbidity and mortality associated with these transfusions. The ECmo hemoSTAtic Transfusions In Children (ECSTATIC) pilot trial will test two different platelet transfusion strategies, based on two different platelet counts thresholds, one high (higher platelet transfusion strategy) and one low (lower platelet transfusion strategy). The pilot will gather the necessary information to perform a full trial which will provide a better understanding of how to transfuse platelets to children supported by ECMO and reduce the associated morbidity.
This study is testing whether pathogen reduced platelets can control bleeding as well as non-pathogen reduced platelets (otherwise known as large volume delayed sampling).
Purpose of this study is to compare the reversal responses of 4°C cold stored platelets (CSP) versus 7 day, 22°C room temperature stored platelets (RTP) when given to healthy adult subjects who have received a loading dose of aspirin antiplatelet therapy.
This study is to evaluate the safety of intravenous (IV) infusion of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP) in participants with World Health Organization (WHO) Grade 2 bleed in spite of receiving a transfusion of liquid stored platelets (LSP) in the past 48 hours by collecting adverse events (AEs) and by evaluating coagulation-related parameters to assess the evidence of any thrombotic events after CPP or LSP transfusion.
The purpose of this study is to determine the life span and functional characteristics of platelets derived from whole blood that has been stored in a refrigerator for up to 21 days. Currently, platelets are separated from red cells shortly after donation and stored at room temperature for no longer than 5 days. This study is considered experimental because; 1) we will be keeping platelets in the original whole blood donor unit in the refrigerator, and 2) we will be reinfusing a small portion of that donation back into the study-subject-donor and tracking how many of the transfused platelets from that unit circulate in the study-subject-donor in the hours and days after transfusion.
Thrombocytopenia (low platelet count) is common in the neonatal intensive care unit. Commonly, the decision of when to transfuse platelets is based on platelet number. Recently, Christensen et al (2006) proposed using transfusion guidelines based on platelet mass rather than platelet number. By using platelet size as a guide of when to give platelets, we may be able to decrease the amount platelet transfusions needed. This study is investigating using platelet size rather than platelet number as a guideline for transfusing platelets in infants who are hospitalized in a NICU (neonatal intensive care unit). After obtaining parental informed consent, thrombocytopenic infants will be randomized to one of two groups. 1: Transfusion based on platelet number; 2: transfusion based on a combination of platelet number and platelet mass. In each group the decision to transfuse platelets will be made using a slightly different, yet strict set of transfusion rules. The objective is to determine the feasibility, rate of bleeding complications and compliance of transfusing neonates based on platelet mass rather than platelet number. The investigators hypothesize that transfusing platelets based on platelet mass will not increase bleeding complications and will reduce the number of transfusions in thrombocytopenic neonates.
Objectives: * Determine the corrected count increment of autologous transfused platelets that had been stored by cryopreservation with ThromboSol. * Determine the ability of autologous platelets that had been stored by cryopreservation with ThromboSol to correct thrombocytopenia.
Open-label randomized controlled trial to test the effectiveness of whole blood transfusion for improving survival in children with severe malaria complicated by thrombocytopenia.
To evaluate the hemostatic efficacy of a low dose platelet transfusion strategy compared to a standard dose platelet transfusion strategy.