Clinical trials: Cardio-pulmonary Bypass
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
Cardiac Surgery
DMSO Cryopreserved Platelets in Cardiopulmonary Bypass Surgery (CRYPTICS)
A randomized, parallel group, active comparator-controlled trial to evaluate the non-inferiority or superiority of Cryopreserved Platelets with Liquid Stored Platelets in controlling blood loss in patients undergoing…
- Trial name
- CRYPTICS (NCT04709705)
- Testing
- Human platelets
- Where
- 16 sites in United States
- Volunteers
- 161 people
- Sponsor
- Cellphire Therapeutics, Inc.
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
Pulmonary Hypertension
VentaProst Versus Conventionally-Administered Aerosolized Epoprostenol in Patients Undergoing Cardiac Surgery With CPB
The purpose of the Phase 2a study is to: 1) demonstrate that the estimated VentaProst dose is safe and equivalent in effect to a dose administered via epoprostenol aerosolization by the current off-label-use practice; and 2)…
- Trial name
- NCT03122730
- Testing
- VentaProst
- Where
- 3 sites in United States
- Volunteers
- 17 people
- Sponsor
- Aerogen Pharma Limited
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)
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 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
Acquired Bleeding Disorder, Cardiac Surgery Requiring Cardiopulmonary Bypass
Multi-national Study Investigating the Effect and Safety of rFXIII on Transfusion Needs in Patients Undergoing Heart Surgery
This trial is conducted in Canada, Asia, Europe and USA. The aim of this clinical trial is to investigate the effect and safety of rFXIII on transfusion needs in patients undergoing heart surgery.
- Trial name
- NCT00914589
- Testing
- catridecacog
- Where
- 32 sites in United States, Canada and 8 more
- Volunteers
- 479 people
- Sponsor
- Novo Nordisk A/S
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
Hypotension, Cardiopulmonary Bypass
Pharmacokinetics and Pharmacodynamics of MTR105 in Hypotensive Cardiac Surgery Patients
The purpose of this study is to evaluate the safety, pharmacokinetic and the pharmacodynamic effects of escalating doses of MTR105 while weaning from bypass in a hypotensive population of cardiac surgery patients.
- Trial name
- NCT00482287
- Testing
- MTR105
- Where
- United States
- Sponsor
- Meditor Pharmaceuticals Ltd.
Cardiac Surgery, Heart Surgery
Safety and Performance Evaluation of CPB Venous and Arterial Cannulas
This is a two-phase study evaluating the Eurosets arterial and venous cannulas for use during cardiopulmonary bypass (CPB) procedures. Phase 1 is a pilot study focused on assessing cannula safety.
- Conditions
- Cardiac Surgery, Heart Surgery, Cardiopulmonary Bypass, Coronary Surgery
- Trial name
- NCT07354841
- Testing
- Eurosets Venous and Arterial Cannula, Control Arterial and Venous Cannulas
- Where
- Italy
- Volunteers
- 80 people
- Sponsor
- Eurosets S.r.l.
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
Acquired Bleeding Disorder, Cardiac Surgery Requiring Cardiopulmonary Bypass
Use of Activated Recombinant Human Factor VII in Cardiac Surgery
This trial is conducted in Africa, Asia, Europe, South America and the United States of America (USA). The trial is planned to investigate the safety and efficacy of NovoSeven® in the management of post-operative bleeding in…
- Trial name
- NCT00154427
- Testing
- activated recombinant human factor VII
- Where
- 63 sites in United States, Argentina and 12 more
- Volunteers
- 172 people
- Sponsor
- Novo Nordisk A/S
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)
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
Cardiac Surgery, Thoracic Surgery
Heart Lung Machine Registry
The HeaLMe post-market clinical follow-up registry is undertaken to evaluate the safety and performance of the index devices Heart Lung Machine HL 40 and Temperature Probes TPO-D-HLM L1.8 Adult / Pediatric in patients undergoing…
- Conditions
- Cardiac Surgery, Thoracic Surgery, Vascular Surgery, Cardiopulmonary Bypass
- Trial name
- HeaLMe (NCT06159517)
- Where
- 3 sites in Italy, Spain
- Volunteers
- 184 people
- Sponsor
- Maquet Cardiopulmonary GmbH
Prevention of Venous Thromboembolism
Efficacy And Safety Of Heparin In Patients With Cardiovascular Surgery Using Cardiopulmonary Bypass
The primary objective of this study is to verify, through a randomized, blinded, parallel clinical trial, the efficacy of bovine heparin from Eurofarma Laboratory product when compared to porcine heparin APP Pharmaceutical in…
- Trial name
- NCT01072955
- Testing
- Bovine Heparin, Porcine heparin
- Where
- Brazil
- Volunteers
- 104 people
- Sponsor
- Azidus Brasil
Cerebral Autoregulation Impairment, Postoperative Cognitive Dysfunction
BrainProtect-guided, Real-time Cerebral Autoregulation Monitoring and Protection of Brain During Cardiac Surgery With Cardiopulmonary Bypass Requiring Heart-lung Machine
The purpose of this clinical investigation is to evaluate the clinical performance, safety, and clinical benefit of the BrainProtect System in reducing early postoperative neurological complications in adult participants…
- Conditions
- Cerebral Autoregulation Impairment, Postoperative Cognitive Dysfunction, Postoperative Delirium
- Trial name
- BrainProtect (NCT07872982)
- Testing
- BrainProtect System, Standard perioperative management
- Where
- 4 sites in United States, Austria and 2 more
- Volunteers
- 304 people
- Sponsor
- Scienceforbrain, UAB
Cardiopulmonary Bypass
The Performance of Pulse Oximeters in Pediatric Patients With Low Oxygen Saturation Levels
Evaluate pulse oximeters with children after cardiopulmonary by-pass under low Oxygen conditions.
- Trial name
- NCT00854048
- Where
- China
- Volunteers
- 66 people
- Sponsor
- Ulf Borg