Clinical trials: Cardiopulmonary-bypass
Congenital Heart Disease, Disorder of Fetus or Newborn
Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass
Although cardiopulmonary bypass (heart-lung machine) is a necessary component of heart surgery, it is not without consequences. Cardiopulmonary bypass initiates a potent inflammatory response secondary to the body's recognition…
- Trial name
- NCT01579513
- Testing
- Methylprednisolone
- Where
- 2 sites in United States
- Volunteers
- 190 people
- Sponsor
- Medical University of South Carolina
Cardiopulmonary Bypass Surgery
Post-market Clinical Follow-up Study on the Performance and Safety of a Vent Catheter Used During Cardiopulmonary Bypass.
Prior to the implementation of the Medical Device Regulation (MDR), the clinical evaluation of existing devices was conducted by Notified Bodies (NBs) based on clinical data obtained from equivalent devices, and CE certificates…
- Trial name
- NCT07628920
- Testing
- Vent Catheter
- Volunteers
- 45 people
- Sponsor
- Bıçakcılar Tıbbi Cihazlar Sanayi ve Ticaret A.Ş.
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 in Children, Neuroprotection
Cerebrum and Cardiac Protection With Allopurinol in Neonates With Critical Congenital Heart Disease Requiring Cardiac Surgery With Cardiopulmonary Bypass
Neurodevelopmental impairment due to delayed brain development and brain injury is a fundamental problem in children with critical congenital heart disease (CCHD).
- Trial name
- CRUCIAL (NCT04217421)
- Testing
- Allopurinol, Mannitol
- Where
- 4 sites in Netherlands
- Volunteers
- 236 people
- Sponsor
- dr. M.J.N.L. Benders
Aortic Aneurysm, Aortic Dissection
Freestyle Prosthesis for Aortic Root-replacement With and Without Hemiarch Replacement
The Freestyle® prosthesis (Medtronic plc, Dublin, Ireland) is a biological, porcine aortic root implanted in various combinations and techniques since the 1990s.
- Conditions
- Aortic Aneurysm, Aortic Dissection, Endocarditis, Root Abscess
- Trial name
- NCT04068337
- Testing
- Aortic root replacement with Freestyle biological prosthesis with and without hemiarch replacement
- Where
- Switzerland
- Volunteers
- 278 people
- Sponsor
- Triemli Hospital
Systemic Inflammatory Response Syndrome (SIRS), Sepsis
Genotypes and Phenotypes in Pediatric SIRS and Sepsis
The aim of this investigation is to longitudinally quantify host gene expression and serum proteins in children with infectious and non-infectious SIRS.
- Trial name
- GAPPSS (NCT02728401)
- Where
- United States
- Volunteers
- 104 people
- Sponsor
- Seattle Children's Hospital
Congenital Heart Disease
Antithrombin III in Infants With Cardiopulmonary Bypass (CPB)
The purpose of this study is to discern whether supplementation of Antithrombin III will decrease coagulation and inflammation associated with cardiopulmonary bypass in infants undergoing cardiac surgery.
- Trial name
- NCT01698567
- Testing
- Antithrombin III
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- University of Rochester
Thrombosis
Risk of Developing Antibodies to Heparin-PF4 After Heart Surgery
Heparin is a drug that is widely used to prevent and treat blood clotting. Individuals undergoing cardiopulmonary bypass surgery are administered high doses of heparin, and some of them develop antibodies to the drug.
- Trial name
- HIT (NCT00237328)
- Testing
- Heparin
- Where
- 4 sites in United States
- Volunteers
- 1,015 people
- Sponsor
- Duke University
Cardiac Surgery, Cardiopulmonary Bypass
Change in Platelet Lipid Metabolism and Procoagulant Phenotype Induced by Cardiopulmonary Bypass. Impact on Postoperative Inflammatory Response and Bleeding Complications During Cardiac Surgery.
The PLACARD research project aims to investigate the impact of CPB-induced platelet modifications during cardiac surgery on the post-operative inflammatory response and bleeding complications.
- Conditions
- Cardiac Surgery, Cardiopulmonary Bypass, Platelet Activation
- Trial name
- PLACARD (NCT07630987)
- Testing
- Arterial blood sample
- Where
- Belgium
- Volunteers
- 100 people
- Sponsor
- Université Catholique de Louvain
Inflammation
Effects of Hemofiltration and Mannitol Treatment on Cardiopulmonary-Bypass Induced Immunosuppression
After cardiac surgery with cardiopulmonar bypass, the LPS-stimulated cytokine response has been previously shown to be depressed.
- Trial name
- NCT00426192
- Testing
- i.v. mannitol, hemofiltration
- Where
- Germany
- Volunteers
- 52 people
- Sponsor
- University Hospital, Saarland
Systemic Inflammatory Response Syndrome, Cardiac Diseases
Dexamethasone for Cardiac Surgery Trial
This is a multicenter, randomized, double-blind trial, comparing clinical outcomes after the administration of high-dose dexamethasone versus placebo in patients undergoing heart surgery with the use of cardiopulmonary bypass.
- Conditions
- Systemic Inflammatory Response Syndrome, Cardiac Diseases, Postoperative Complications
- Trial name
- NCT00293592
- Testing
- Dexamethasone
- Where
- Netherlands
- Volunteers
- 4,500 people
- Sponsor
- UMC Utrecht
Cardiac Surgical Procedures, Cardiopulmonary Bypass
Sequestration of Platelets Prior to Bypass Reduces Bleeding After Cardiac Surgery
Excessive bleeding is common after cardiac surgery. This may result in patients receiving a blood transfusion or suffering the life-threatening complication of cardiac tamponade.
- Conditions
- Cardiac Surgical Procedures, Cardiopulmonary Bypass, Blood Platelet Disorders, Blood Coagulation Disorders
- Trial name
- NCT00359398
- Testing
- Platelet rich plasma sequestration
- Where
- United Kingdom
- Volunteers
- 30 people
- Sponsor
- Royal Brompton & Harefield NHS Foundation Trust
Cardiac Surgery, Oxidative Stress
The Effects of Peep and Tidal Volume on Oxidative Stress in Cardiopulmonary Bypass Surgery
Although cardio-pulmonary bypass surgery (CPBS) is a routine procedure worldwide, patient morbidity and mortality are still high due to postoperative negative complications.Inflammatory response and systemic oxidative stress have…
- Trial name
- NCT03601364
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people
- Sponsor
- Kahramanmaras Sutcu Imam University
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
Cardiac Arrest
Emergency Cardiopulmonary Bypass for Cardiac Arrest
Cardiac arrest ist associated with a very poor prognosis. Even though resuscitation algorithms and postcardiac arrest care have been improved there is an urgent need for measures leading to a higher survival rate.
- Trial name
- ECPB4OHCA (NCT01605409)
- Testing
- Emergency cardiopulmonary bypass under ongoing CPR, Standard ACLS
- Where
- Austria
- Volunteers
- 40 people
- Sponsor
- Medical University of Vienna
Coronary Artery Bypass Grafting, Mitral Valve Surgery
Levosimendan in Patients With Left Ventricular Systolic Dysfunction Undergoing Cardiac Surgery On Cardiopulmonary Bypass
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…
- Conditions
- Coronary Artery Bypass Grafting, Mitral Valve Surgery, Low Cardiac Output Syndrome
- Trial name
- LEVO-CTS (NCT02025621)
- Testing
- Levosimendan
- Where
- 60 sites in United States, Canada
- Volunteers
- 882 people
- Sponsor
- Tenax Therapeutics, Inc.
Acute Kidney Injury, Cardiac Surgery
Kidney Oxygen Saturation and Neutrophil Gelatinase-associated Lipocalin (NGAL) for Detecting Acute Kidney Injury (AKI) After Cardiac Surgery
Acute kidney injury (AKI) is an important complication following cardiac surgery with cardiopulmonary bypass (CPB). Early identification of patients at risk of AKI may facilitate timely clinical management.
- Conditions
- Acute Kidney Injury, Cardiac Surgery, Cardiopulmonary Bypass
- Trial name
- NCT07837037
- Testing
- Renal Near-Infrared Spectroscopy Monitoring, Neutrophil Gelatinase-Associated Lipocalin (NGAL) Measurement
- Where
- Turkey (Türkiye)
- Volunteers
- 85 people
- Sponsor
- Haseki Training and Research Hospital
Acute Kidney Injury
The Goal dIrected perFusion Trial in Cardiac Surgery
Previous studies (1-5) have demonstrated that oxygen delivery (DO2) and carbon dioxide production (VCO2) during cardiopulmonary bypass (CPB) are associated with renal outcome in cardiac surgery.
- Trial name
- GIFT (NCT02250131)
- Testing
- Perfusion targeted at oxygen delivery
- Where
- Italy
- Volunteers
- 350 people
- Sponsor
- IRCCS Policlinico S. Donato
Postoperative Delirium
Predictors for Postoperative Delirium After Cardiac Surgery in Adults: a One-year, Single Center, Observational Cohort Study
The Diagnostic and Statistical Manual of Mental Disorders, 5th ed. (DSM-5) describes delirium as a "disturbance in attention (i.e., reduced ability to direct, focus, sustain, and shift attention) and awareness (reduced…
- Trial name
- PODCAS (NCT02613845)
- Testing
- no intervention
- Where
- Switzerland
- Volunteers
- 656 people
- Sponsor
- University Hospital, Basel, Switzerland
Cardiac Surgery, Heart Surgery
Novel Venous Cannula Trial
This is a prospective, open-label, single-arm, single-center clinical investigation designed to evaluate the safety and performance of a Novel Venous Cannula during on-pump cardiac surgery requiring transfemoral venous…
- Conditions
- Cardiac Surgery, Heart Surgery, Cardiopulmonary Bypass, Minimally Invasive Surgical Procedures
- Trial name
- NCT07087639
- Testing
- Self-expanding Venous Cannula
- Where
- Italy
- Volunteers
- 42 people
- Sponsor
- Eurosets S.r.l.