Clinical trials: Cardiac Surgery Subjects
Coronary Artery Bypass Surgery
Reduction of Ischemia-Reperfusion Mediated Cardiac Injury in Subjects Undergoing Coronary Artery Bypass Graft Surgery
This clinical trial will investigate the safety and effectiveness of IK-1001 (the liquid form of sodium sulfide) when used in Coronary Artery Bypass Graft (CABG) patients to potentially reduce the damage done to the heart during…
- Trial name
- NCT00858936
- Testing
- IK-1001, Normal Saline
- Where
- 8 sites in Australia, Canada
- Volunteers
- 6 people
- Sponsor
- Mallinckrodt
Cardiac Surgery Requiring Cardiopulmonary Bypass and Median Sternotomy, Cardiopulmonary Bypass
Safety and Hemostatic Efficacy of Fibrin Sealant Vapor Heated, Solvent/Detergent Treated (FS VH S/D) Compared With Currently Licensed TISSEEL VH Fibrin Sealant in Subjects Undergoing Cardiac Surgery
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.
- Conditions
- Cardiac Surgery Requiring Cardiopulmonary Bypass and Median Sternotomy, Cardiopulmonary Bypass, Sternotomy
- Trial name
- NCT00161733
- Testing
- Fibrin Sealant Vapor Heated Solvent/Detergent Treated (FS VH S/D), TISSEEL VH fibrin sealant
- Where
- 22 sites in United States
- Sponsor
- Baxter Healthcare Corporation
Bloodloss, Surgical Procedures, Operative
Outcomes and Safety Trial Investigating Ecallantide's Effect on Reducing Surgical Blood Loss Volume in Subjects at High Risk of Bleeding Exposed to Cardio-pulmonary Bypass During Cardiac Surgery
A Phase 2 Randomized Double-Blind Active-Controlled Study in Subjects Exposed to Cardio-pulmonary Bypass During Cardiac Surgery at High Risk of Bleeding
- Trial name
- CONSERV-2 (NCT00888940)
- Testing
- Ecallantide, Cyklokapron(R)
- Where
- 34 sites in United States, Germany and 1 more
- Volunteers
- 243 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Cardiac Surgery
QPI-1002 Phase 3 for Prevention of Major Adverse Kidney Events (MAKE) in Subjects at High Risk for AKI Following Cardiac Surgery
This trial is designed to evaluate QPI-1002 versus placebo for the prevention of Major Adverse Kidney Events (MAKE) in subjects at high risk for acute kidney injury following cardiac surgery.
- Trial name
- NCT03510897
- Testing
- teprasiran
- Where
- 104 sites in United States, Australia and 9 more
- Volunteers
- 1,043 people
- Sponsor
- Quark Pharmaceuticals
Aortic Valve Disease, Aortic Stenosis
EDWARDS INTUITY Valve System CADENCE Study
The study purpose is to compare the EDWARDS INTUITY valve system with commercially available stented aortic bioprostheses, in patients requiring aortic valve replacement surgery with coronary artery bypass.
- Trial name
- CADENCE (NCT02688153)
- Testing
- EDWARDS INTUITY, Stented aortic bioprostheses
- Where
- France
- Volunteers
- 120 people
- Sponsor
- Edwards Lifesciences
Atrial Fibrillation, Atrial Flutter
Response to RSD1235 Compared to Placebo in Subjects With Atrial Arrhythmia After Heart Surgery
The purpose of this study is to demonstrate the safety and efficacy of RSD1235 compared to placebo in the conversion of atrial arrhythmia to sinus rhythm in subjects following valvular and/or coronary artery bypass graft surgery.
- Trial name
- NCT00125320
- Testing
- RSD1235
- Where
- 22 sites in United States, Argentina and 4 more
- Volunteers
- 190 people
- Sponsor
- Astellas Pharma Inc
Coronary Disease
Study of INS50589 Intravenous Infusion in Subjects Undergoing Coronary Artery Bypass Grafting (CABG) Involving Cardiopulmonary Bypass
The purpose of this trial is to identify a dose or doses of INS50589 intravenous infusion that are well-tolerated and which reduce postoperative bleeding and blood product transfusion.
- Trial name
- NCT00316212
- Testing
- INS50589 Intravenous Infusion
- Where
- 27 sites in United States
- Volunteers
- 160 people
- Sponsor
- Merck Sharp & Dohme LLC
Acute Lung Injury
L-citrulline for Prevention of Sequelae of Acute Lung Injury in Pediatrics Undergoing Cardiopulmonary Bypass for Heart Defects
The purpose of this study is to determine whether L-citrulline is effective and safe in the prevention of clinical sequelae of Acute Lung Injury in pediatric subjects undergoing surgery for congenital heart defects.
- Trial name
- NCT02891837
- Testing
- L-citrulline
- Where
- 29 sites in United States, Austria and 2 more
- Volunteers
- 189 people
- Sponsor
- Asklepion Pharmaceuticals, LLC
Acute Kidney Injury
A Safety and Efficacy Trial of Multiple Dosing Regimens of ABT-719 for the Prevention of Acute Kidney Injury in Subjects Undergoing High Risk Cardiac Surgery
This study will evaluate the safety and efficacy of ABT-719 in preventing acute kidney injury in patients undergoing high risk cardiac surgery.
- Trial name
- NCT01777165
- Testing
- ABT-719
- Where
- 41 sites in United States, Denmark
- Volunteers
- 240 people
- Sponsor
- AbbVie
Bloodloss, Surgical Procedures, Operative
A Dose-ranging Safety and Efficacy Study of Ecallantide to Reduce Surgical Blood Loss Volume
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.
- Trial name
- CONSERV-1 (NCT00816023)
- Testing
- ecallantide
- Where
- 29 sites in United States, Canada
- Volunteers
- 276 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Acute Kidney Injury
Efficacy and Safety of RMC-035 in Subjects at High Risk for Acute Kidney Injury Following Open-Chest Cardiac Surgery
This study evaluates RMC-035 compared to placebo for the prevention of acute kidney injury (AKI) in subjects who are at high risk for AKI following cardiac surgery.
- Trial name
- AKITA (NCT05126303)
- Testing
- RMC-035
- Where
- 29 sites in United States, Canada and 3 more
- Volunteers
- 177 people
- Sponsor
- Guard Therapeutics AB
AKI
Effect of RBT-1 on Preconditioning Response Biomarkers in Subjects Undergoing CABG and/or Cardiac Valve Surgery
The purpose of this study is to evaluate the effect of RBT-1 (stannous protoporphyrin [SnPP]/iron sucrose [FeS]) on preconditioning response biomarkers in subjects who are at risk for AKI following cardiac surgery.
- Trial name
- START (NCT04564833)
- Testing
- Low Dose RBT-1, High Dose RBT-1
- Where
- 25 sites in United States, Australia and 1 more
- Volunteers
- 152 people
- Sponsor
- Renibus Therapeutics, Inc.
Cardiac Surgery
Evaluation of Renal Function in Subjects Who Had Undergone Cardiac Surgery
To evaluate the differences between serum cystatin C based estimated glomerular filtration rate (eGFRcys), serum creatinine based eGFR (eGFRcreat) and measured glomerular filtration rate (mGFR) in subjects at high risk for acute…
- Trial name
- NCT04654221
- Testing
- mGFR by iohexol clearance
- Where
- 6 sites in United States
- Volunteers
- 16 people
- Sponsor
- Quark Pharmaceuticals
Delirium
A Research Study to Evaluate the Effectiveness of Dexmedetomidine in Preventing Delirium After Heart Surgery
The purpose of this study is to evaluate the efficacy and safety of dexmedetomidine in the prevention of postoperative delirium in subjects undergoing heart valve surgery with or without coronary artery bypass surgery (CABG)…
- Trial name
- NCT00464763
- Testing
- Dexmedetomidine
- Where
- 11 sites in United States
- Sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
Aortic Valve Stenosis
REPRISE IV: LOTUS Edge Valve System in Intermediate Surgical Risk Subjects
REPRISE IV: REpositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of LOTUS Edge Valve System in IntermediatE Surgical Risk Subjects
- Trial name
- REPRISE IV (NCT03618095)
- Testing
- LOTUS Edge Valve System
- Where
- 50 sites in United States, Australia
- Volunteers
- 382 people
- Sponsor
- Boston Scientific Corporation
Acute Kidney Injury (AKI)
Study to Evaluate the Efficacy of ASP1128 (MA-0217) in Subjects at Risk for Acute Kidney Injury (AKI) Following Coronary Artery Bypass Graft (CABG) and/or Valve Surgery
The purpose of this study was to evaluate the efficacy of postsurgery treatment with ASP1128 in subjects at risk for AKI following CABG and/or valve surgery.
- Trial name
- NCT03941483
- Testing
- ASP1128
- Where
- 27 sites in United States
- Volunteers
- 351 people
- Sponsor
- Astellas Pharma Inc
Surgical Wound Infection
Effects of a New Antimicrobial Dressing on Wound Healing and Incidence of Sternal Wound Infections
The primary objective of this pivotal study is to determine if a new antimicrobial dressing, applied to the sternal incisions of cardiac surgical subjects, will demonstrate a decreased cumulative incidence rate(CI) of localized…
- Trial name
- NCT00203541
- Testing
- TELFA™ A.M.D. Island dressing
- Where
- United States
- Volunteers
- 1,100 people
- Sponsor
- Tyco Healthcare Group
Cardiovascular Disease
Phase II Study To Evaluate The Safety and Efficacy of Hemoglobin Raffimer in Patients Undergoing First Time CABG Surgery
To evaluate the efficacy of Hemolink™ in combination with Intraoperative Autologous Donation (IAD) versus control (IAD alone) in facilitating avoidance of allogeneic RBC transfusion during and following primary CABG surgery
- Trial name
- NCT00038454
- Testing
- Hemolink (hemoglobin raffimer IV solution)
- Where
- 28 sites in United States, Canada and 1 more
- Volunteers
- 180 people
- Sponsor
- Hemosol
Aortic Valve Disease, Aortic Stenosis
EDWARDS INTUITY Valve System CADENCE-MIS Study
The study purpose is to compare the EDWARDS INTUITY valve system in a minimal invasive surgical approach (MIS) with any commercially available aortic bioprosthesis in standard full sternotomy surgical approach.
- Trial name
- CADENCE-MIS (NCT02672553)
- Testing
- EDWARDS INTUITY Valve System, Model 8300A, Stented Aortic Bioprostheses
- Where
- Germany
- Volunteers
- 100 people
- Sponsor
- Edwards Lifesciences
Severe Aortic Stenosis
Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI).
The purpose of the study is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk by randomizing patients…
- Trial name
- SURTAVI (NCT01586910)
- Testing
- Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI), Surgical Aortic Valve Replacement (SAVR), Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
- Where
- 86 sites in United States, Canada and 7 more
- Volunteers
- 1,746 people
- Sponsor
- Medtronic Cardiovascular