Clinical trials: Bypass, Cardiopulmonary
Cardiopulmonary Bypass
Hemosonics- VCU Cardiac Surgery Clinical Study
This study compares the results of current standard coagulation measurement devices to the Quantra System, a new device, using small amount of extra blood obtained during routine blood draws in cardiac surgery patients.
- Trial name
- NCT02392247
- Testing
- Coagulation function
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- Virginia Commonwealth University
Cardiac Surgery, Cardiopulmonary Bypass
Voluven® in Paediatric Patients
This study will compare the clinical efficacy and safety of Voluven® and Human Albumin during elective open-heart surgery in pediatric patients.
- Trial name
- NCT00860405
- Testing
- HES 130/0.4 (6%) in sodium chloride (Voluven®, solution for infusion), Human serum albumin (HSA 50g/L), Human serum albumin (HSA 50g/L)
- Where
- 2 sites in Austria, Belgium
- Volunteers
- 61 people
- Sponsor
- Fresenius Kabi
Congenital Heart Defects
Phase 3 Triiodothyronine Supplementation for Infants After Cardiopulmonary Bypass
This is a study to determine the safety and efficacy of liothyronine sodium/triiodothyronine (Triostat), a synthetic thyroid hormone, when given to infants with congenital heart disease during cardiopulmonary bypass surgery.
- Trial name
- TRICC-2 (NCT02320669)
- Testing
- Triostat
- Where
- 3 sites in United States
- Volunteers
- 220 people
- Sponsor
- Seattle Children's Hospital
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)
Congenital Heart Disease
Fibrinogen Concentrate vs Cryoprecipitate
One of the most common hemostatic derangements in pediatric open- heart surgery is an acute acquired hypofibrinogenemia. This compromises fibrin clot generation and platelet aggregation, resulting in increased bleeding and…
- Trial name
- NCT03014700
- Testing
- Fibrinogen Concentrate, Cryoprecipitate
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- Stanford University
Acute Kidney Injury
Effect of Nitric Oxide in Cardiac Surgery Patients With Endothelial Dysfunction.
The purpose of this study is to determine whether nitric oxide is effective in the treatment of acute kidney injury in cardiac surgical patients with sign and laboratory data suggesting endothelial dysfunction undergoing…
- Trial name
- MGHK23 (NCT02836899)
- Testing
- Nitric Oxide
- Where
- United States
- Volunteers
- 250 people
- Sponsor
- Massachusetts General Hospital
Coronary Artery Bypass Graft, Cardiopulmonary Bypass
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MDCO-2010 in Patients Undergoing Elective Coronary Artery Bypass Graft Surgery
The purpose of this study is to demonstrate that periprocedural infusion of escalating doses of MDCO-2010 is safe and tolerated in patients undergoing elective CABG surgery, to characterize the single dose pharmacokinetics of…
- Trial name
- NCT01535222
- Testing
- MDCO-2010
- Volunteers
- 32 people
- Sponsor
- The Medicines Company
Vitamin D Deficiency, Cardiomyopathies
Can Vitamin D Reduce Heart Muscle Damage After Bypass Surgery?
Background and study aim: Heart diseases are among the most common causes of death worldwide. A large proportion of deaths are caused by heart attacks (myocardial infarction), where blood flow to the heart is reduced resulting in…
- Conditions
- Vitamin D Deficiency, Cardiomyopathies, Apoptosis, Inflammation
- Trial name
- NCT04323852
- Testing
- Vitamin D
- Where
- Iran
- Volunteers
- 70 people
- Sponsor
- Shahid Beheshti University of Medical Sciences
Coronary Artery Disease, Angiotensin Converting Enzyme
The RAS, Fibrinolysis and Cardiopulmonary Bypass
Each year over a million patients worldwide undergo cardiac surgery requiring cardiopulmonary bypass (CPB).1 CPB is associated with significant morbidity including hemodynamic instability, the transfusion of allogenic blood…
- Conditions
- Coronary Artery Disease, Angiotensin Converting Enzyme, Angiotensin Receptor Blockers, Cardiopulmonary Bypass
- Trial name
- NCT00607672
- Testing
- Ramipril, Candesartan
- Where
- 2 sites in United States
- Volunteers
- 111 people
- Sponsor
- Vanderbilt University
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
Chronic Kidney Disease, CKD
ARTEMIS: Ravulizumab to Protect Patients With CKD From CSA-AKI and MAKE
The primary objective of this study is to assess the efficacy of a single dose of ravulizumab IV compared with placebo in reducing the risk of the clinical consequences of AKI (MAKE) at 90 days in adult participants with CKD who…
- Conditions
- Chronic Kidney Disease, CKD, Cardiac Disease, Cardiopulmonary Bypass
- Trial name
- ARTEMIS (NCT05746559)
- Testing
- Ravulizumab
- Where
- 130 sites in United States, Argentina and 18 more
- Volunteers
- 555 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Cardiopulmonary Bypass Surgery
HPI (Hypotension Prediction Index) Care Trial
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…
- Trial name
- NCT05083403
- Testing
- AcumenTM HPI Software Feature, Non-protocolized Standard of Care
- Where
- United States
- Volunteers
- 170 people
- Sponsor
- Edwards Lifesciences
Complication of Extracorporeal Circulation, Renal Impairment
Renal Perfusion, Filtration and Oxygenation During Cardiopulmonary Bypass (CPB)
Acute kidney injury is a common complication after cardiac surgery with cardiopulmonary bypass (CPB). This study aims to investigate the effects of CPB on renal perfusion, filtration and oxygenation.
- Trial name
- ECCSTUD (NCT02405195)
- Testing
- cardiopulmonary bypass
- Where
- Sweden
- Volunteers
- 28 people
- Sponsor
- Sahlgrenska University Hospital
Impaired Thermoregulation
Heat Retention Head Wrap Use for Re-warming of Infants Requiring Cardio-Pulmonary Bypass
This is a phase I descriptive pilot study to determine the feasibility of using the Heat Retention Head Wrap on infants during the re-warming period following cardio-pulmonary bypass.
- Trial name
- NCT01675830
- Testing
- Heat Retention Head Wrap
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Cardiology Clinical Research & Regulatory Group
Lung Transplant; Complications
Bypass vs. Ecmo in Lung Transplantation (BELT)
This study seeks to compare outcomes of 2 different methods of cardiopulmonary support during lung transplant surgeries.
- Trial name
- BELT (NCT03021538)
- Testing
- Extracorporeal Membrane Oxygenation, Cardiopulmonary Bypass
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- The Cleveland Clinic
Coronary Artery Disease, Sternal Pain
Pecto-Intercostal Fascial Block for Postoperative Analgesia After Cardiac Surgery
The purpose of this study is to determine whether administration of a pecto-intercostal fascial plane block (PIFB) with bupivacaine is a more effective therapy for postoperative analgesia after cardiac surgery as compared to…
- Trial name
- NCT03482973
- Testing
- Bupivacaine Group
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Beth Israel Deaconess Medical Center
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
Renal Failure
Does Nesiritide Provide Renal Protection
This project evaluates whether nesiritide, human recombinant brain natriuretic peptide, confers renal protection during cardiovascular surgery by attenuating the inflammatory response.
- Trial name
- NCT01440881
- Testing
- Nesiritide
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- University of Florida
Acute Kidney Injury
Safety & Efficacy of BCT197 in Patients Undergoing Cardiac Surgery
This study will assess the safety and efficacy of BCT197 on acute kidney injury in patients undergoing cardiac surgery with cardiopulmonary bypass.
- Trial name
- NCT01336959
- Testing
- BCT197 Part A, BCT197 Part B
- Where
- 13 sites in United States, Israel and 1 more
- Volunteers
- 91 people
- Sponsor
- Mereo BioPharma
Valvular Heart Surgery
Efficacy of Prothrombin Complex Concentrate Reducing Perioperative Blood Loss in Cardiac Surgery
This non-inferiority, randomized controlled trial aims to evaluate whether coagulation-guided low-dose four-factor prothrombin complex concentrate (PCC) is non-inferior to fresh frozen plasma (FFP) in reducing cumulative chest…
- Trial name
- NCT04244981
- Testing
- Prothrombin Complex Concentrate, Human, Fresh Frozen Plasma
- Where
- 2 sites in China
- Volunteers
- 476 people
- Sponsor
- SHI Jia