Clinical trials: Surgery (Cardiac)
Inflammatory Lung Injury, Ischemia-Reperfusion Lung Injury
Anesthetics to Prevent Lung Injury in Cardiac Surgery
The purpose of this study is to investigate whether the use of inhaled anesthetics, compared to intravenous anesthetics, can affect the amount of lung inflammation and postoperative respiratory complications seen after cardiac…
- Conditions
- Inflammatory Lung Injury, Ischemia-Reperfusion Lung Injury, Postoperative Pulmonary Complications
- Trial name
- APLICS (NCT02918877)
- Testing
- Sevoflurane, Propofol
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- Beth Israel Deaconess Medical Center
Saphenous Vein Graft Disease
Ticagrelor Antiplatelet Therapy to Reduce Graft Events and Thrombosis
Saphenous vein graft disease remains an unresolved medical problem. Many vein grafts occlude in the first year after bypass surgery, leading to adverse cardiovascular outcomes, including recurrent angina, myocardial infarction…
- Trial name
- TARGET (NCT02053909)
- Testing
- Aspirin, Ticagrelor
- Where
- 2 sites in United States, Canada
- Volunteers
- 250 people
- Sponsor
- Boca Raton Regional Hospital
Congenital Heart Disease
Transfusion Strategies in Pediatric Cardiothoracic Surgery
The purpose of this study is to determine the best red blood cell(hemoglobin) level for infants and children following surgical repair of particular heart defects.
- Trial name
- NCT00350220
- Testing
- transfusion strategy, Low Hb transfusion group
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- University of Rochester
Cardiac Output, Low
Comparison Between NICOM-Cheetah and Flotrac-Vigileo for Cardiac Output Monitoring.
Cardiac output (CO) monitoring is an important tool in critically ill patients with haemodynamic instability. Traditionally, this has been accomplished using the pulmonary artery catheter (PAC).
- Trial name
- NCT03394768
- Testing
- No additional intervention
- Where
- Singapore
- Volunteers
- 26 people
- Sponsor
- Changi General Hospital
Coronary Artery Bypass Graft Triple Vessel
Effect of Prewarming on Microcirculatory Response
Intraoperative hypothermia may affect tissue microcirculation and can induce myocardial injury, wound infection, and coagulopathy.
- Trial name
- NCT02186210
- Testing
- prewarming
- Where
- South Korea
- Volunteers
- 40 people
- Sponsor
- Seoul National University Hospital
Pediatric HD, Bleeding
Comparison of Fibrinogen Concentrate and Cryoprecipitate in Pediatric Cardiac Surgery Patients
The aim of the current pilot study proposal is to compare the use of the purified human fibrinogen concentrate (Fibryga®, Octapharma USA) to cryoprecipitate for the treatment of cardiopulmonary bypass (CPB)-associated bleeding in…
- Trial name
- NCT04376762
- Testing
- Fibrinogen, Cryoprecipitate
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- University of Virginia
Bicuspid Aortic Valve
Medtronic Transcatheter Aortic Valve Replacement (TAVR) Low Risk Bicuspid Study
The objective of the trial is to evaluate the procedural safety and efficacy of the Medtronic TAVR system in patients with bicuspid aortic anatomy and severe aortic stenosis at low risk for SAVR
- Trial name
- NCT03635424
- Testing
- Medtronic TAVR Systems
- Where
- 25 sites in United States
- Volunteers
- 150 people
- Sponsor
- Medtronic Cardiovascular
Congenital Heart Defect
Erythropoietin and Pediatric Cardiac Surgery
Lack of bloodflow to the heart and brain when the heart is stopped during heart surgery can cause damage to those organs. We hypothesize that a single dose of erythropoietin prior to the heart bypass portion of surgery may…
- Trial name
- EPO (NCT00451698)
- Testing
- acyanotic erythropoietin
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Medical College of Wisconsin
Cardiac Disease, Cardiac Ischemia
Assessment of Patients Undergoing Cardiac Surgery and Admitted to the Intensive Care Unit
The objective of this study is to investigate the incidence of death and early postoperative complications, identify potential risk factors, and examine the demographic characteristics of patients and epidemiology of…
- Conditions
- Cardiac Disease, Cardiac Ischemia, Cardiac Valve Disease
- Trial name
- BraSIS-2 (NCT06154473)
- Testing
- Open heart surgery group., Percutaneous cardiovascular surgery group.
- Where
- Brazil
- Volunteers
- 528 people
- Sponsor
- Hospital Israelita Albert Einstein
Atrial Septal Defect
Utilization of Confocal Microscopy During Cardiac Surgery
The investigators propose to translate confocal microscopy for use during open heart surgery. This tool will help discriminate between various types of tissues in the heart during surgery.
- Trial name
- NCT03189134
- Testing
- Fluorescite, Cellvizio 100 Series System with Confocal Miniprobes
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Aditya Kaza
Coronary Artery Disease, General Anesthetic Drug Allergy
Xenon Compared to Sevoflurane and Total Intravenous Anaesthesia for Coronary Artery Bypass Graft Surgery
Xenon is a gaseous anaesthetic agent registered in several European countries. It has been administered safely during cardiac surgery in pilot studies.
- Conditions
- Coronary Artery Disease, General Anesthetic Drug Allergy, Coronary Artery Bypass Graft Surgery
- Trial name
- NCT01294163
- Testing
- Xenon, Sevoflurane, Propofol
- Where
- 17 sites in France, Germany and 2 more
- Volunteers
- 509 people
- Sponsor
- Air Liquide Santé International
Acute Kidney Injury
Aminophylline to Prevent Acute Kidney Injury in Children After Cardiac Surgery
Children with congenital heart defects often need cardiac surgery with cardiopulmonary bypass (the "heart-lung machine"). Approximately 35 to 50% of these children will have "acute kidney injury," or damage to the kidneys, after…
- Trial name
- KIDPROAM (NCT01245595)
- Testing
- Aminophylline
- Where
- United States
- Volunteers
- 144 people
- Sponsor
- Stanford University
Aortic Valve Insufficiency, Aortic Valve Regurgitation
Aortic or Mitral Valve Replacement With the Biocor and Biocor Supra
The purpose of this study is to further evaluate the long-term safety and effectiveness of the Biocor and Biocor Supra Valves.
- Conditions
- Aortic Valve Insufficiency, Aortic Valve Regurgitation, Aortic Valve Stenosis, Aortic Valve Incompetence
- Trial name
- NCT00636987
- Testing
- Biocor and Biocor Supra valves
- Where
- 17 sites in United States
- Volunteers
- 297 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Bypass Surgery, Postoperative Complications
Glutamate for Metabolic Intervention in Coronary Surgery II
The aim of GLUTAMICS II is to evaluate whether intravenous glutamate infusion surgery reduces the risk of postoperative heart failure as measured by plasma NT-proBNP in patients undergoing moderate to high-risk coronary artery…
- Conditions
- Coronary Artery Bypass Surgery, Postoperative Complications, Heart Failure
- Trial name
- GLUTAMICSII (NCT02592824)
- Testing
- glutamate infusion, saline infusion
- Where
- 4 sites in Sweden
- Volunteers
- 321 people
- Sponsor
- University Hospital, Linkoeping
Cardiac Surgery, Sternal Wound Infection
Safety and Efficacy of an Antibiotic Implant in Cardiac Surgical Subjects at Higher Risk for Sternal Wound Infection
The purpose of this study is to determine whether the gentamicin-collagen sponge is safe and effective in preventing sternal wound infections in patients undergoing cardiac surgery who are at a greater risk of developing sternal…
- Trial name
- NCT00600483
- Testing
- gentamicin-collagen sponge dipped in saline
- Where
- 43 sites in United States
- Volunteers
- 1,502 people
- Sponsor
- Innocoll
Aortic Regurgitation
HAART Model 300 Annuloplasty Ring
This investigation is a prospective, non-randomized, multi-center trial to evaluate the safety and effectiveness of the HAART model 300 annuloplasty ring when used to surgically repair a leaking aortic valve using a 3-D…
- Trial name
- NCT01400841
- Testing
- HAART 300 Annuloplasty Device
- Where
- 4 sites in Belgium, Czechia and 1 more
- Volunteers
- 18 people
- Sponsor
- Biostable Science & Engineering
Focus of Study, Coagulation Status of Cardiac Surgery Patient
Thromboelastography-derived Functional Fibrinogen Levels
This study hopes to determine if thromboelastography-derived functional fibrinogen (TEG-FF or FLEV) levels obtained during the rewarming phase of cardiopulmonary bypass can provide information on coagulation status sooner…
- Conditions
- Focus of Study, Coagulation Status of Cardiac Surgery Patient, Reducing Excess Blood Transfusion
- Trial name
- TEG-FF (NCT01992757)
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- University of Pennsylvania
Elective Cardiac Surgery
CytoSorb® Reduction of FREee Hemoglobin/Acute Kidney Injury (AKI) During Cardiac Surgery
Prospective, multi-center, randomized, blinded, pivotal clinical study. Subjects will be randomized in a 1:1 ratio to either standard of care (SOC) alone or standard of care plus treatment with the CytoSorb® device.
- Trial name
- REFRESH II-AKI (NCT03384875)
- Testing
- CytoSorb
- Where
- 20 sites in United States
- Volunteers
- 186 people
- Sponsor
- CytoSorbents, Inc
Hemorrhage, Soft Tissue Bleeding
The EVARREST® Paediatric Mild/Moderate Liver and Soft Tissue Bleeding Study
The objective of this study is to evaluate the safety and effectiveness of EVARREST™ Sealant Matrix (EVARREST™ Fibrin Sealant Patch) (EVARREST™) in controlling mild or moderate soft tissue \& parenchymal bleeding during open…
- Conditions
- Hemorrhage, Soft Tissue Bleeding, Hepatic Parenchyma Bleeding
- Trial name
- NCT02227992
- Testing
- EVARREST™ Sealant Matrix, SURGICEL®
- Where
- 10 sites in Belgium, United Kingdom
- Volunteers
- 40 people
- Sponsor
- Ethicon, Inc.
Mitral Regurgitation, Mitral Insufficiency
Study on Safety and Performance of Medtentia Mitral Valve Repair System in Surgical Repair of Mitral Regurgitation
The purpose of the trial is to demonstrate the safety and performance of the Medtentia Annuloplasty Ring (MAR) during mitral valve repair surgery.
- Trial name
- NCT01678144
- Testing
- Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)
- Where
- Finland
- Volunteers
- 12 people
- Sponsor
- Medtentia International Ltd Oy