Clinical trials: Cardio-Pulmonary Bypass
Cardiac Surgical Procedures, Extracorporeal Circulation; Complications
Acute Kidney Injury After Cardiac Surgery
PrimECC is a colloid priming solution for cardiopulmonary bypass/ extracorporeal circulation (ECC) based on Ringers Lactate, supplmeneted with Dextran 40 and Dextran 1.
- Conditions
- Cardiac Surgical Procedures, Extracorporeal Circulation; Complications, Acute Kidney Injury
- Trial name
- NCT04293744
- Testing
- Colloid priming solution for ECC circuit, Standard priming solution for ECC circuit
- Where
- Sweden
- Volunteers
- 100 people
- Sponsor
- XVIVO Perfusion
Complex Cardiovascular Surgery With Cardiopulmonary Bypass
Efficacy and Safety of 4F-PCC (4-Factor Prothrombin Complex Concentrate) in Adult Patients Undergoing Complex Cardiovascular Surgery With Cardiopulmonary Bypass (CPB)
This is a phase 3, multicenter, randomized, open-label, parallel-group, controlled study to assess the efficacy and safety of BE1116 compared with fresh frozen plasma (FFP) in adult participants undergoing complex cardiovascular…
- Trial name
- NCT07094087
- Testing
- BE1116, FFP
- Where
- 24 sites in United States, Canada and 2 more
- Volunteers
- 200 people
- Sponsor
- CSL Behring
Acquired Antithrombin Deficiency
Phase 3 Study on the Efficacy and Safety of Human Plasma Derived Antithrombin (Atenativ) in Heparin-Resistant Patients Scheduled to Undergo Cardiac Surgery Necessitating Cardiopulmonary Bypass
The primary objective of this study is to evaluate the efficacy of two different doses of Atenativ, versus placebo, in restoring and maintaining heparin responsiveness in adult patients undergoing cardiac surgery necessitating…
- Trial name
- NCT06096116
- Testing
- Human plasma derived antithrombin
- Where
- 27 sites in United States, Austria and 8 more
- Volunteers
- 120 people
- Sponsor
- Octapharma
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
Cardiopulmonary Bypass, ARDS
Breethe Abiomed Recovery RegisTry (BART)
The BART Registry intended to utilize observational data of the Abiomed Breethe OXY-1 System™ in real-world settings to drive best practice usage patterns, serve as a tool to measure and improve the quality of patient care and as…
- Conditions
- Cardiopulmonary Bypass, ARDS, Heart Failure
- Trial name
- BART (NCT05473130)
- Testing
- Breethe Oxy-1 System
- Where
- 6 sites in United States
- Volunteers
- 48 people
- Sponsor
- Abiomed Inc.
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
Heart Disease
Initial Experience With the AngioVac Venous Drainage Cannula
This is a retrospective, record-based study of approximately 100 patients across up to 12 centers within the United States. All patients who have been treated with the AngioVac Venous Drainage Cannula and the Extracorporeal…
- Trial name
- NCT02775565
- Testing
- AngioVac
- Where
- 5 sites in United States
- Volunteers
- 51 people
- Sponsor
- Angiodynamics, Inc.
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 Surgical Procedures
Pilot Study of the Genius(TM)2 Tympanic Thermometer in Cardiac Patients Requiring Cardiopulmonary Bypass
Primary study objective is to test the accuracy of the Genius 2 tympanic thermometer and the Exergen TAT-5000(TM) temporal artery thermometer as compared with serial perioperative core temperature measurements obtained in cardiac…
- Trial name
- NCT01029314
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Tyco Healthcare Group
Acquired Bleeding Disorder, Cardiac Surgery Requiring Cardiopulmonary Bypass
Safety of rFXIII in Patients Following First Time Myocardial Revascularization Requiring Cardiopulmonary Bypass
This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to evaluate the safety of escalating single doses of rFXIII (recombinant factor XIII, catridecacog) administered following first…
- Trial name
- NCT02239146
- Testing
- catridecacog
- Where
- 24 sites in United States, Canada and 3 more
- Volunteers
- 43 people
- Sponsor
- Novo Nordisk A/S
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
Left Ventricular Dysfunction
IMpella-Protected cArdiaC Surgery Trial (IMPACT)
The purpose of this Trial is to demonstrate the safety and effectiveness of the use of Impella 5.5 in high-risk cardiac surgery patients, with the overall aim to evaluate if using Impella 5.5 with SmartAssist (Impella 5.5)…
- Trial name
- IMPACT (NCT05529654)
- Testing
- Impella 5.5 with SmartAssist
- Where
- 20 sites in United States
- Volunteers
- 100 people
- Sponsor
- Abiomed Inc.
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
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
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
Heart Failure
CentriMag Ventricular Assist System in Treating Failure-to-Wean From Cardiopulmonary Bypass for Pediatric Patients
The purpose of the study is to evaluate the safety and effectiveness of the CentriMag ventricular assist system to help pediatric patients who have experienced heart failure during surgery and cannot be removed from cardiac…
- Trial name
- NCT01171950
- Testing
- CentriMag Ventricular Assist System
- Sponsor
- Abbott Medical Devices
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.
Cardio-pulmonary Bypass, Coronary Artery Bypass Graft
Effect of Pexelizumab on All-Cause Mortality and Myocardial Infarction in Patients Undergoing Coronary Artery Bypass Graft Surgery With Cardio-Pulmonary Bypass
During a heart bypass procedure, a substance called "complement" is released by the body. This complement causes inflammation, which can lead to side effects such as chest pain, heart attacks, heart failure, or impairment of…
- Trial name
- NCT00048308
- Testing
- pexelizumab
- Where
- 186 sites in United States, Canada
- Volunteers
- 3,000 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Coronary Artery Bypass Graft Surgery, Myocardial Ischemia
MEND-CABG (MC-1 to Eliminate Necrosis and Damage in Coronary Artery Bypass Graft Surgery)
The purpose of this study is to determine whether MC-1 is effective and safe in reducing cardiovascular and neurological events in patients undergoing high-risk coronary artery bypass surgery
- Conditions
- Coronary Artery Bypass Graft Surgery, Myocardial Ischemia, Reperfusion Injury, Myocardial Revascularization
- Trial name
- NCT00157716
- Testing
- (MC-1) Pyridoxal-5'-phosphate
- Where
- 2 sites in United States, Canada
- Volunteers
- 900 people
- Sponsor
- Medicure
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