175 Clinical Trials for Various Conditions
A Phase 2 Randomized Double-Blind Active-Controlled Study in Subjects Exposed to Cardio-pulmonary Bypass During Cardiac Surgery at High Risk of Bleeding
The purpose of this study is to assess the efficacy and identify the optimal dose(s) of ecallantide in reducing blood loss in subjects undergoing coronary artery bypass surgery including the use of cardio pulmonary bypass.
The purpose of this study is to assess if aprotinin (BAY A0128), given intravenously during surgery, is safe and can help reduce the amount of bleeding and the need for a blood transfusion during hip replacement surgery. Patients undergoing major surgery are at risk for significant blood loss. Because of this, there is a need for drugs that will help slow the amount of bleeding during surgery.
This study aims to find out if tranexamic acid (TXA), a medication, works to decrease blood loss during a specific surgery called Aquablation therapy, which is a treatment for men with Benign Prostatic Hyperplasia (BPH). BPH is a common condition in men over the age of 45 that involves enlargement of the prostate gland and can lead to problems or discomfort with urination. The main goal of this research is to see if TXA can help reduce the amount of blood loss during surgery compared to not using the drug. This is important because losing less blood during surgery can help patients recover faster and more safely. Researchers will monitor the safety of TXA and its effects on other outcomes, like the length of hospital stay and any possible changes in blood tests that check how well blood clots. Participants in this study will: * Be males diagnosed with BPH who are already scheduled to undergo Aquablation therapy. * Be randomly assigned to either receive TXA or a placebo (a look-alike substance that contains no drug) right before their surgery. * Not know which treatment they are receiving to make sure the results are unbiased. Researchers hope to engage participants who meet the health criteria of the study. They will be carefully monitored before, during, and after the surgery for any health changes, and their blood loss during surgery will be measured. This study does not require any additional time commitment outside of the standard surgical process, and all treatments will be provided at no additional cost to the participants. The researchers will ensure that all participants understand the procedure and support their safety throughout the research.
The objective of this study is to determine if tAN therapy can reduce the volume of blood lost during dialysis AV graft placement procedures.
Tranexamic acid (TXA) is a synthetic anti-fibrinolytic agent that has been well studied and routinely used for hip and knee arthroplasty. In hip and knee arthroplasty, the use of tranexamic acid decreases blood loss and the need for transfusion without increasing the risk of thromboembolic events. Due to the increased use of reverse total shoulder arthroplasty in the treatment of shoulder pathology, there has been interest in making the procedure safer for patients. TXA is a promising drug which could be useful to surgeons as they seek to achieve this goal, however, it has not been extensively studied in this setting. The purpose of this prospective randomized, controlled study is to determine the effectiveness and safety of using tranexamic acid to decrease blood loss in reverse total shoulder arthroplasty.
Although serious complications from second trimester abortion are rare hemorrhage is the most common cause of procedural abortion related morbidity and mortality. Misoprostol is a prostaglandin E1 analogue that is used by 75% of clinicians prior to procedural abortion for the purpose of cervical preparation. Misoprostol is also known to decrease blood loss in first trimester abortion and is used to treat postpartum hemorrhage, however the effect of preprocedural misoprostol on procedural blood loss is not well described. We will conduct a double blinded placebo-controlled gestational age stratified superiority trial of those undergoing procedural abortion between 18 and 23 weeks gestation at Stanford Health care. Participants will be randomized to either 400mcg buccal misoprostol or placebo on the day of the procedure. A quantified blood loss (QBL) will be measured during the procedure and participants will complete a survey to assess symptoms. Our primary outcome is quantified blood loss. Secondary outcomes include clinical interventions to manage excess bleeding, total procedure time, provider reported experience, patient reported experience.
The study is a prospective, non-randomized, non-blinded, non-significant risk study enrolling up to 60 healthy adult subjects consented to undergo a 1-unit whole blood draw procedure. Subjects will wear the study device (CM-1500) while positioned in either a supine or reclined position during the blood draw and study-required physiological parameters will be captured pre-, during, and post-donation.
The goal of this interventional study is to compare the efficacy (surgical field quality and intra-operative blood loss) or cost of TIVA alone to general inhalational anesthetics with intravenous TXA in patient participants who are undergoing endoscopic sinus surgery. The main questions the study aims to answer are: * Is the surgical field quality better when using TIVA alone compared to general inhalational anesthetics with intravenous TXA? * Is one method more financially advantageous to the participant and the institution compared to the other method? Participants will be randomized into one of the two anesthesia cohorts prior to sinus surgery. One group will be given total intravenous anesthesia (TIVA) alone and the other will be given intravenous tranexamic acid (TXA) followed by general inhalational anesthesia. Researchers will compare the TIVA group to the TXA group to see if one group exhibits a better surgery field viewing quality through a subjective evaluation and measurement of blood loss and also which anesthesia regimen is most cost effective upon conducting a cost analysis.
To determine if placental cord drainage decreases the blood loss after spontaneous vaginal delivery
The study is a prospective, non-randomized, non-blinded, non-significant risk, multi-center study enrolling up to 500 healthy adult subjects consented to undergo a whole blood donation procedure. The study will involve enrolling subjects that will undergo blood donation wearing the study device (CM-1600 Device) and capture study-required physiological parameters pre-, during, and post-donation.
The overall objectives and purpose of this study is to show that the Smith and Nephew Werewolf Fastseal 6.0 Bipolar Sealer is an effective tool to aide the surgical team in providing significant hemostasis during anterior total hip arthroplasty which would subsequently improve patient outcomes.
Postpartum hemorrhage (PPH) is the leading cause of maternal morbidity and mortality worldwide. Up to 80% of PPH is caused by uterine atony, the failure of the uterine smooth muscle to contract and compress the uterine vasculature after delivery. Laboratory and epidemiological studies show that low extracellular and serum calcium levels, respectively, decrease uterine contractility. A pilot study performed by the investigators supports the hypothesis that intravenous calcium chloride is well tolerated and may have utility in preventing uterine atony. The proposed research will establish the relationship between uterine tone and calcium through a clinical trial with an incorporated pharmacokinetic and pharmacodynamic (PK/PD) study. In a randomized, placebo-controlled, double-blind trial, investigators will establish the effect of 1 gram of intravenous calcium chloride upon quantitative blood loss and uterine tone during cesarean delivery in parturients with high risk of uterine atony. Investigators will concurrently collect serial venous blood samples to measure calcium for PK/PD modeling in this pregnant study cohort. High-quality clinical research and development of novel therapeutics to manage uterine atony are critical to reduce the high maternal morbidity and mortality from PPH.
Our present study aims to initiate TXA administration immediately upon diagnosis of hip fracture in the Emergency Department. This will be a single blind randomized controlled trial comparing early administration of TXA in the ED in addition to perioperative dosing versus the standard perioperative administration only. The study population will include patients who have sustained a femoral neck, intertrochanteric, or subtrochanteric femur fracture and are undergoing surgical internal fixation or arthroplasty. We will prospectively compare the need for blood transfusion, total and hidden blood loss, postoperative complications, length of stay and readmission within 30 days.
This study will be a prospective cohort study. Patients who meet criteria for inclusion in the study will be approached for participation at same day of admission. Written informed consent will be obtained from the patients by the Co-principal investigator and by the study collaborators. If patients agree to participate, a CBC (complete blood count) will be obtained via venous puncture routine in our facility as part of the admission labs which will be around 10 cc of blood. The device will be used during the delivery in laboring room. The device will be used to assess QBL (quantitative blood loss) by the research staff only and results/ QBL assessment will be masked to the clinical team. Unmasking will only occur following study completion with purpose to perform data analysis. Patient management will be according to the clinical team without the knowledge of the QBL. All patients undergo a CBC postpartum as part of post-partum evaluation, this will also be performed by venipuncture where 10 cc of blood will be collected. The drop in Hgb (hemoglobin) between the pre and post partum CBCs will be calculated for each patient. The post-partum CBC will be collected approximately 24-30 hours from delivery as standard in our unit. The blood will be collected from each patient by the nursing staff who are experienced in withdrawing blood. Patients will be divided into quartiles of Hgb. Cases will be those patients whose Hgb is in the upper quartile, while controls will be those patients whose Hgb is in the lower 3 quartiles. We will be comparing visual EBL (estimated blood loss) by standard clinical assessment versus the QBL result from the device between cases and controls. The Triton L\&D (labor and delivery) system which comprises of the device, software analysis and staff training will be supplied by the manufacturer free of charge. Research staff will be trained by the manufacturer. We will be offering our skills, fellows, midwifes and residents, who will be collecting data and we will be performing the data analysis. Results will be available to the manufacturer after results are completed. The results of this study will be presented in conferences or published in a peer-review journal. Demographic information will be obtained from the electronic medical record. The data will be kept on a password secured University of Texas Medical Branch (UTMB) computer. An encrypted USB flash drive will be used to transfer data. The data will be identified and linked to the patient using the medical record number. During data analysis, all patient identifiers will be deleted.
Perioperative variables that can be used to create a bundled approach quality improvement protocol to minimize blood loss in spine surgery will be evaluated using retrospective data collection and multivariate analysis of previously performed spinal surgeries at Johns Hopkins Hospital. In particular the investigators are interested in determining whether FloSeal® contributes towards increased control over perioperative bleeding compared to other hemostatic agents for potential inclusion in a future bundled approach.
The purpose of this study is to establish a benchmark for measuring blood loss by directly measuring the change in red cell volume before and after surgery and to compare established blood loss estimators to this benchmark in order to determine the most accurate and precise method for estimating blood loss in adolescent idiopathic scoliosis surgery patients
In this research study the investigators want to learn more about how a medication called tranexamic acid (TXA) could help reduce bleeding during Periacetabular Osteotomy (PAO) surgery. TXA is approved by the Food and Drug Administration (FDA) for the reduction of bleeding for many types of surgical procedures. TXA works by slowing the breakdown of blood clots and helps to prevent bleeding. From previous studies, TXA has been shown to effectively prevent bleeding in patients undergoing heart, spine and skull remodeling surgeries. As PAO surgery has been associated with significant blood loss when compared to other types of joint surgeries. In order to try and avoid bleeding that may lead to complications, different strategies can be used. In this research study the investigators want to learn more about how a medication called tranexamic acid (TXA) could help reduce bleeding during PAO surgery.
Postpartum hemorrhage (PPH) is the leading cause of maternal mortality in low-income countries and the primary cause of nearly one quarter of all maternal deaths globally. Estimates of blood loss at delivery are notoriously inaccurate, with under-estimation more common than over-estimation. Traditionally, the surgeon performing the cesarean section would estimate the blood loss by visually assessing the blood collected in the surgical drape and counting the number of lap sponges used thru out the procedure. The investigators would like to study and validate an FDA approved device called the gauss Triton device used to estimate blood loss during scheduled cesarean sections.
This is a prospective cohort study of patients delivering at Columbia University Medical Center/ Allen Hospital. For the primary research question, the investigators will compare the change in maternal hemoglobin from postpartum day 1 to day 2 and also determine correlation with estimation of blood loss (EBL) and quantitative blood loss (QBL).
The purpose of this study is to compare the effects of Oxymetazoline and Epinephrine (which are 2 different nasal decongestants both of which are routinely used before sinus surgery) on blood loss and the surgeon's view of the surgical field during sinus surgery.
Intertrochanteric hip fractures typically result in blood loss from the fracture and require surgery that can cause further blood loss. This study is being done to look at a medication called tranexamic acid which may reduce blood loss and the need for blood transfusions associated with surgery.
This early phase I trial studies how well tranexamic acid works in reducing the loss of blood in patients with pelvic tumors undergoing hemipelvectomy surgery. Tranexamic acid decreases blood loss by stabilizing clots and preventing clot lysis in patients undergoing surgery.
The purpose of this study is to determine the need for a blood transfusion during surgery and to evaluate the levels of certain proteins in the blood when given tranexamic acid.
The primary objective of this study is to assess the safety and efficacy of Tranexamic acid (TXA) in reducing blood loss and transfusion requirements for patients with osteoporotic hip fractures. In addition to assessing blood loss in these patients, complications associated with TXA use would be characterized including systemic (pulmonary embolism, deep venous thrombosis, myocardial infarction, stroke) and surgical site (hematoma, infection) events, need for re-hospitalization or re-operation and 30 day mortality.
The purpose of this study is to evaluate the effect of non-dissecting the inferior rectus sheath during primary cesarean delivery on post-operative hemoglobin and post-operative pain control as measured by VAS score and opioid anesthesia use in the first 72 hours post-op.
Tranexamic acid (TA) inhibits fibrinolysis by binding to lysine binding-sites of plasminogen to fibrin. Fibrinolysis is stimulated by surgical trauma, and the administration of TA has been shown effective in decreasing blood loss both intra-operatively and in the immediate post-operative period in elective hip and knee arthroplasty patients. Both the timing and dosing of TA has been investigated in these patients. Subsequent blood transfusion rate has also been shown to decrease as result of TA administration. Despite the support for TA utilization that exists in the arthroplasty literature, the data is scarce regarding its administration during surgical treatment of hip fractures. This is patient population who is at high risk for transfusion due to symptomatic post-operative anemia. This study aims to investigate whether TA's advantageous effects in the arthroplasty patient population can be extrapolated to the more unstable, heterogeneous hip fracture patient population. If the study is able to show a difference in blood loss and transfusion requirement, the long term implications of this with regards to cost and mortality can be significant.
The purpose of this study is to determine if patients undergoing acetabular ORIF (open reduction with internal fixation) who receive tranexamic acid have a reduced risk of allogenic blood transfusion, perioperative blood loss, wound complication and higher risk for thromboembolic events compared to patients who receive placebo. Investigators want to determine the cost-effectiveness related to allogenic blood transfusion as a blood loss management strategy in acetabular open reduction internal fixation (ORIF). Orthopaedic surgery carries with it a significant risk for blood loss. Current management of perioperative blood loss is the use of allogenic blood transfusion. Allogenic blood transfusion carries with it a risk for HIV and Hepatitis C as well as multiple adverse reactions. There have been significant efforts to reduce the use of allogenic blood transfusion in orthopaedic surgery. Tranexamic acid, an anti-fibrinolytic agent, has been used in management of blood during surgery. In order to determine the impact of tranexamic acid in reducing blood loss among patients undergoing acetabular ORIF, investigators will conduct a prospective randomized study. Patients undergoing acetabular surgery will be screened for this study. Patients will be then randomized to placebo or tranexamic acid which will be administered during and after surgery. The following data will be collected: patient characteristics, surgery information, blood loss, blood transfusions, wound complication within 30 days of surgery, and cost.
The aim of this study is to assess the ability of the Triton Device to measure blood loss among women undergoing elective and non-elective cesarean delivery. This patient population often experiences significant blood loss during surgery, and measurements of surgical blood loss are often inaccurate.
This document defines the Clinical Investigation Protocol for a study designed to determine whether blood loss after spontaneous vaginal delivery is altered by the addition of misoprostol administration to the standard use of intravenous oxytocin after delivery. The protocol is an open-label randomized prospective trial to be carried out at Queens Hospital Center. Blood loss will be measured indirectly by comparing the maternal hemoglobin and hematocrit levels on admission in labor to those obtained within 24 hours after delivery.