Clinical trials: Cardiac Surgery With Cardiopulmonary Bypass
- Condition Cardiac Surgery With Cardiopulmonary Bypass
- Funder type Industry (pharma, biotech, devices)
Heart; Dysfunction Postoperative, Cardiac Surgery
Clinical Assessment of Nonin 7600 Near Infrared Spectroscopy (NIRS) Tissue Oximetry During Cardiovascular Surgery
An observational study designed to evaluate the performance of a new Near Infrared Spectroscopy (NIRS) tissue oximeter device in the clinical setting, including a cerebral sensor and peripheral sensor.
- Trial name
- NCT01289470
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Nonin Medical, Inc
Coronary Disease, Heart Valve Diseases
CTI-01 (Ethyl Pyruvate) Safety and Complication Prevention in Cardiac Surgery Patients on Cardiopulmonary Bypass (CPB)
Over 500,000 patients undergo cardiac surgery with CPB in the United States annually. Although mortality rates have decreased with advances in perioperative care, many patients are affected by postoperative organ dysfunction.
- Trial name
- NCT00107666
- Testing
- CTI-01 (ethyl pyruvate)
- Where
- 17 sites in United States
- Volunteers
- 150 people
- Sponsor
- Critical Therapeutics
Renal Insufficiency, Acute Kidney Injury
Renal Assist Device (RAD) for Patients With Renal Insufficiency Undergoing Cardiac Surgery
The study is a prospective, non-randomized early feasibility study intended to evaluate the safety and performance of the JuxtaFlow System (also known as the JuxtaFlow Renal Assist Device (RAD)) in participants with pre-existing…
- Trial name
- BIPASS-AKI (NCT05990660)
- Testing
- JuxtaFlow System
- Where
- 3 sites in Poland, Serbia
- Volunteers
- 10 people
- Sponsor
- 3ive Labs
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
Acquired Bleeding Disorder, Cardiac Surgery Requiring Cardiopulmonary Bypass
Activated Recombinant Human Factor VII Following Cardiac Bypass Surgery for Paediatric Congenital Heart Disease
This trial is conducted in Oceania. The aim of this trial is to investigate the efficacy of activated recombinant human factor VII and standard treatment compared with standard haemostatic replacement therapy in cardiopulmonary…
- Trial name
- NCT01562574
- Testing
- activated recombinant human factor VII
- Where
- Australia
- Volunteers
- 82 people
- Sponsor
- Novo Nordisk A/S
Coronary Artery Disease
A Study of Hemopure® to Enhance Tissue Preservation During Cardiopulmonary Bypass Surgery
The purpose of this study is to determine if Hemopure® will enhance tissue preservation during Cardiopulmonary Bypass surgery.
- Trial name
- NCT00301535
- Testing
- HBOC-201 (hemoglobin glutamer-250 bovine)
- Where
- 3 sites in Greece, South Africa and 1 more
- Volunteers
- 60 people
- Sponsor
- Biopure Corporation
Pulmonary Hypertension
A Study to Evaluate the Efficacy, Safety and Tolerability of PDNO Infusion in Patients With Pulmonary Hypertension After Cardiopulmonary Bypass Surgery
This is an open-label, multicenter study evaluating the dose, effect, safety and tolerability of intravenous PDNO infusion given to patients undergoing cardiopulmonary bypass (CPB) surgery with post-operative acute pulmonary…
- Trial name
- NCT05699486
- Testing
- PDNO
- Where
- 2 sites in Sweden
- Volunteers
- 12 people
- Sponsor
- Attgeno AB
Cardiovascular Disease, Coronary Artery Bypass Surgery
Angiomax in Patients With HIT/HITTS Type II Undergoing CPB
The purpose of this study is to demonstrate that in patients with heparin-induced thrombocytopenia (HIT)/heparin-induced thrombocytopenia and thrombosis syndrome (HITTS) Type II undergoing cardiac surgery on cardiopulmonary…
- Trial name
- HIT/TS (NCT00079508)
- Testing
- Angiomax (bivalirudin)
- Where
- United States
- Volunteers
- 125 people
- Sponsor
- The Medicines Company
Advanced Heart Failure, Ischemic Heart Failure
HiCM-188 Cell Therapy in Adults With Advanced Heart Failure Undergoing Heart Bypass Surgery
This clinical study will evaluate the safety and tolerability of HiCM-188, an investigational allogeneic induced pluripotent stem cell (iPSC)-derived cardiomyocyte therapy, in adults with advanced heart failure who are undergoing…
- Trial name
- NCT07646210
- Testing
- HiCM-188 Cells
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- HELP Therapeutics Co., Ltd.
Systemic Inflammation, Cardiopulmonary-bypass
Preventing Systemic Inflammation After Cardiac Surgery With Alkaline Phosphatase
Study should demonstrate that alkaline phosphatase reduces the incidence and extent of acute kidney injury after cardiopulmonary bypass (CPB) as defined by the AKIN criteria.
- Trial name
- APPIRED-III (NCT03050476)
- Testing
- RESCAP®
- Where
- 21 sites in Australia, Austria and 9 more
- Volunteers
- 1,250 people
- Sponsor
- Alloksys Life Sciences B.V.
CPB, Oral Anticoagulant Therapy
Study Use of PPSB-SD and VP-VI in Patients With Anticoagulant Therapy and Undergoing Acute CPB Surgery
The purpose of this study was to study the efficacy of PPSB-SD and VP-VI in patients, who received anticoagulant treatment and who had to undergo acute cardiac surgery with a cardiopulmonary bypass (CPB).
- Trial name
- NCT00151853
- Testing
- PPSB-SD
- Where
- Belgium
- Volunteers
- 40 people
- Sponsor
- Prothya Biosolutions
Heart Diseases, Hypertension, Pulmonary
Study of the Efficacy and Safety of Tezosentan in Patients With Pre-operative Pulmonary Hypertension, Due to Left Heart Disease, Undergoing Open Heart Surgery
Endothelin-1 is a powerful substance that may be involved in causing hemodynamic instability (problems related to unstable blood pressure) during and after open heart surgery.
- Trial name
- NCT00458276
- Testing
- tezosentan
- Where
- 33 sites in United States, Austria and 12 more
- Volunteers
- 274 people
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Acquired Antithrombin III Deficiency, Coronary Artery Bypass
Use of Antithrombin in Cardiac Surgery With Cardiopulmonary Bypass
The purpose of this trial is to study the effects of preoperative antithrombin supplementation in patients undergoing cardiac surgery with cardiopulmonary bypass in order to maintain antithrombin levels in a range greater than…
- Trial name
- NCT00823082
- Testing
- Antithrombin III
- Where
- Italy
- Volunteers
- 200 people
- Sponsor
- Instituto Grifols, S.A.
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.
Cardiovascular Disease, Coronary Artery Bypass Surgery
Comparing Angiomax to Heparin With Protamine in Patients Undergoing Cardiopulmonary Bypass (CPB)
The purpose of this study is to demonstrate that in patients undergoing coronary artery bypass grafting (CABG) or CABG-Valve, or Isolated Cardiac Valve surgery on CPB (cardiac surgery), Angiomax is a safe and effective…
- Trial name
- NCT00079586
- Testing
- Heparin, Bivalirudin
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- The Medicines Company
Cardiac Surgery, Cardiopulmonary Bypass
Safety and Efficacy of Preoperative Antithrombin Supplementation in Patients Undergoing High-Risk Cardiopulmonary Bypass
This is a prospective, multicenter, randomized, double-blind, placebo-controlled study. The purpose of this study is to determine the safety and effectiveness of human-derived antithrombin III (AT-III [Human]) supplementation…
- Trial name
- NCT02037555
- Testing
- AT-III (Human)
- Where
- 41 sites in United States
- Volunteers
- 425 people
- Sponsor
- Grifols Therapeutics LLC
Cardiac Surgery-associated Acute Kidney Injury
A Study to Understand How Cardiac Surgery-associated Acute Kidney Injury Develops in Participants Who Undergo Heart Surgery With the Use of Heart-lung Machine
Researchers are looking for a better way to treat and prevent cardiac surgery-associated acute kidney injury (CSA-AKI) in people who undergo heart surgeries.
- Trial name
- NCT06772025
- Testing
- No investigational study intervention
- Where
- 4 sites in Germany, United Kingdom
- Volunteers
- 200 people
- Sponsor
- Bayer
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
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
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