115 Clinical Trials for Various Conditions
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).
A randomized, parallel group, active comparator-controlled trial to evaluate the non-inferiority or superiority of Cryopreserved Platelets with Liquid Stored Platelets in controlling blood loss in patients undergoing Cardiopulmonary Bypass Surgery.
Open heart surgery requires the use of a cardiopulmonary bypass (CPB) circuit. As blood flows across the artificial surfaces of the CPB circuit, platelets are activated and consumed. This activation results in a profound inflammatory reaction and need for transfusion. This reaction is intensified in younger, smaller patients undergoing longer, more complex open heart surgery. Nitric oxide is naturally released by vascular endothelial surfaces and acts as a signaling molecule which prevents platelet activation. The investigators hypothesize that the addition of the nitric oxide to the sweep gas of the oxygenator during cardiopulmonary bypass surgery will replace this natural endothelial function and thus prevent platelet activation and consumption. The investigators plan to test this hypothesis with a pilot double blinded, randomized trial of 40 patients less than a year of age undergoing cardiac surgery requiring CPB.
This study will help enhance current understanding of the impact of Acute Normovolemic Hemodilution (ANH) administration on transfusion requirements post cardiac surgery, the effect of this procedure on coagulation, and platelet hemostasis, and the amount of chest tube drainage 24 hours post coronary artery bypass graft surgery (CABG) surgery.
This is an unblinded, single center, randomized study of infants with congenital heart disease undergoing cardiopulmonary bypass surgery, randomized to either the delayed rewarming intervention or to the standard of care (strict normothermia).
The goal of this study is to determine whether or not exposure to blue spectrum light reduces acute kidney injury and systemic inflammation in subjects undergoing cardiopulmonary bypass. Subjects scheduled to undergo cardiopulmonary bypass surgery will be exposed to either bright (1000 lux) blue spectrum (480nm) light or to ambient, white fluorescent light for a 24 hour photoperiod the day prior to surgery and for a 24 hour photoperiod in the immediate postoperative period.
This investigation is a prospective, open-label pharmacokinetic study of daptomycin prophylaxis in patients undergoing coronary artery bypass graft surgery without valvular replacement.
This study will determine the pharmacokinetics and safety of intravenous citrulline given to children undergoing cardiopulmonary bypass for the correction of congenital heart defects.
The purpose of this study is to determine if the study drug (TP10), which blocks complement release, can reduce such side effects of complement inflammation as chest pain or heart attacks and be taken safely in women who undergo cardiopulmonary bypass surgery.
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.
A prospective single-center randomized controlled trial to determine if guided hemodynamic management with the Acumen HPI technology in the OR and ICU can reduce the mean duration of hypotension in cardiac surgery patients requiring cardiopulmonary bypass.
This study evaluates the safety and efficacy of ketorolac for post-operative pain management after heart surgery. Ketorolac appears to provide enhanced pain relief while also decreasing the requirements for morphine during the (immediate) 24-hour post-operative period.
To demonstrate that using continuous mechanical lung ventilatory support in combination with Positive End Expiratory Pressure (PEEP)during open heart surgery will improve lung function and decrease lung complications after surgery.
This is a retrospective chart review study. The purpose of this study is to review our experience at Children's Healthcare of Atlanta in neonates receiving aprotinin. We will examine the specific outcomes of renal dysfunction, thrombosis and mortality.
In this study the focus will be on correlating the levels of platelet activation markers (proteins that are released when blood cells are activated)to the duration of cardiopulmonary bypass, temperature during cardiopulmonary bypass and the weight of the patient.
Antibiotics are routinely used to prevent surgical wound infection. Vancomycin is a widely used antibiotic for surgery in patients with an allergy to penicillin. During cardiac surgery, cardiopulmonary bypass (CPB) and modified ultrafiltration (MUF) are routinely used and can lower the level of the antibiotic. The purpose of this study is to quantify the change in plasma vancomycin concentration associated with cardiopulmonary bypass and modified ultrafiltration.
Cardiac surgery is a procedure that is commonly performed worldwide. Despite these technological advances, cardiac surgery remains a high-risk surgery. Among post-operative complications, acute kidney injury, respiratory failure, myocardial infarction, and stroke as well as cognitive dysfunction are significant causes of mortality in patients undergoing and following cardiac surgery. Inhaled nitric oxide (NO) therapy as a selective pulmonary vasodilator in cardiac surgery has been one of the most significant pharmacological advances in managing pulmonary hemodynamics and life threatening right ventricular dysfunction and failure. In addition, newer applications show greater promise of inhaled NO as a therapy in the area of cardiac surgery associated acute kidney injury and ischemia reperfusion. However, this remarkable expectation to inhaled NO has experienced a roller-coaster ride with high hopes and nearly universal demonstration of physiological benefits but disappointing translation of these benefits to harder clinical outcomes, like mortality. Most of our understanding on the iNO field in cardiac surgery stems from small observational or single center randomized trials, which failed to ascertain strong evidence base. As a consequence, there are only week clinical practice guidelines on the field and only European expert opinion for the use of iNO in routine and more specialized cardiac surgery. There is need for a large multicenter randomized controlled study to confirm the administration of iNO as an effective weapon for the battle against life threatening complication in high risk cardiac surgical patients. In a previous meta analysis with 27 studies included, we demonstrated that inhaled nitric oxide (NO) could reduce the duration of mechanical ventilation and reducing biomarkers of organ injury and clinical signs of organ dysfunction in cardiac surgery under cardiopulmonary bypass (CPB) , but had no significance in the ICU stay, hospital stay, and mortality. This may be attributed to the small sample size of the most included studies (of the 27 studies included, 20 studies with sample size less than 100) and heterogeneity in timing, dosage and duration of iNO administration. Well-designed, large-scale, multicenter clinical trials are needed to further explore the effect of iNO in improving postoperative prognosis in cardiovascular surgical patients. We are planning a large multicenter controlled randomized trial to demonstrate that inhaled nitric oxide can reduce composite outcome of death and Major Adverse Events (MAEs), including need for intensive supports due to heart failure, low cardiac output sydrome, or renal failure, respiratory failure, etc., and myocardial infarction, stroke, and sepsis at 30 days after surgery from 20% to 16% in patient undergoing cardiac surgery with cardiopulmonary bypass. If the hypothesis had been proved and validated, the results of this study can provide strong evidence for guidelines to facilitate the routine use of iNO in all cardiopulmonary bypass assisted cardiac procedures with 31,800 postoperative outcomes improved per year in US and in China.
The primary objective of this study is to evaluate the efficacy of two different doses of Atenativ, versus placebo, in restoring and maintaining heparin responsiveness in adult patients undergoing cardiac surgery necessitating cardiopulmonary bypass (CPB)
This study aims to confirm the safety and efficacy of diazoxide as an additive to hyperkalemic cardioplegia in patients undergoing cardiac surgery with cardiopulmonary bypass. The investigators hypothesize that diazoxide combined with hyperkalemic cardioplegia provides superior myocardial protection and reduced myocardial stunning compared with standard cardioplegia alone. The investigators will randomize 30 patients in a 2:1 fashion to treatment vs control. Safety will be assessed by comparing mean arterial blood pressure measurements, glucose levels and incidence of adverse events between the two groups. Efficacy will be assessed by comparing right and left ventricular function in pre-operative vs post-operative transesophageal echocardiograms, need for mechanical circulatory support, ease of separation from bypass and Vasoactive Inotrope Score (VIS) between the two groups. The information gained could pave the way for the use of Katp (Potassium-atp) channel openers to prevent stunning, improve patient outcomes, and reduce health care costs related to myocardial stunning that requires inotropic and mechanical support following cardiac surgery.
The objective of the study is to assess the safety and efficacy of ANG-3777 in preventing AKI compared to placebo when administered to patients at risk for developing acute kidney injury (AKI) following cardiac surgical procedures involving cardiopulmonary bypass (CPB).
A study to evaluate levosimendan compared with placebo in reducing the composite event rate of all-cause death, perioperative MI, need for new dialysis, or use of mechanical assist (IABP, LVAD or ECMO) in subjects with reduced ejection fraction undergoing cardiac surgery on cardiopulmonary bypass (CPB).
This is an investigator initiated, sponsored, open label, prospective randomized controlled trial to be performed in adult patients undergoing scheduled cardiac surgery. Patients will be randomized to esmolol infusion or nitroglycerin infusion for control of hypertension that occurs during cardiac surgery from induction of anesthesia to initiation of cardiopulmonary bypass (CPB).
Patients born with heart defects often undergo surgical procedures on a heart lung machine. With improvements in medical and surgical management, their survival has significantly improved, but their brain insult has not been paid much attention. This study is to determine the relationship between specific proteins in the blood and brain injury in patients less than 18-year-old undergoing heart surgery.
The purpose of this research is to learn more about how renin (a blood test) is affected by cardiopulmonary bypass, the heart-lung machine used during open heart surgery. Renin is a protein that may be elevated in response to low blood pressure or situations where organs do not receive sufficient oxygen. Renin may potentially be used as an indicator for specific treatments aimed to increase the blood pressure. This study will evaluate blood samples for renin concentration throughout the course of open heart surgery.
The Primary objective is to reduce the incidence of postoperative renal dysfunction in a high-risk subset of patients undergoing cardiac surgery on cardiopulmonary bypass with Fenolopam, a selective dopamine-1 receptor agonist. Perioperative renal function will be observed in 3 randomly selected groups of patients-Fenoldopam infusion at 0.03 cg/kg/min, Fenoldopam at 0.1 mcg/kg/min or placebo Secondary objective: will be to correlate Fenoldopam usage with postoperative clinical outcomes such as ICU stay, hospital stay, need for inotropes/vasopressors, need for diuretics, requirements for ECF at discharge, and overall perioperative cost reduction through decreased ICU and hospital length of stay.
The objective of this study is to demonstrate equivalent hemostatic efficacy and safety between FS VH S/D and TISSEEL VH fibrin sealant in subjects undergoing cardiac surgery requiring cardiopulmonary bypass. If bleeding is still present after conventional surgical methods to achieve hemostasis have been applied FS VH S/D or Tisseel VH are applied. Achievement of hemostasis within 5 minutes is compared between the study groups.
Acute kidney injury (AKI) is a complication of cardiac surgery that can affect outcome. Near Infrared Spectroscopy (NIRS) is a technology that uses light to determine how well oxygenated tissues are. This technology is routinely used in cardiac surgery to measure the oxygen level in the brain by placing a sensor sticker on the forehead. The purpose of the study is to determine whether NIRS sensor stickers placed on the skin over the kidney can predict AKI better than when sensors are placed on the skin over the participant's limbs. This study is being conducted by investigators from the department of anesthesiology at the University of Utah.
This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to evaluate the safety of escalating single doses of rFXIII (recombinant factor XIII, catridecacog) administered following first time myocardial revascularization requiring cardiopulmonary bypass (CPB).
This trial is conducted in Canada, Asia, Europe and USA. The aim of this clinical trial is to investigate the effect and safety of rFXIII on transfusion needs in patients undergoing heart surgery.
This trial is conducted in Africa, Asia, Europe, South America and the United States of America (USA). The trial is planned to investigate the safety and efficacy of NovoSeven® in the management of post-operative bleeding in patients following cardiac surgery.