Clinical trials: Cardiopulmonary Bypass Surgery
Bleeding Reduction
Biomarker and Thrombogenicity Assessment in Cardiopulmonary Bypass Surgery Utilizing Acute Normovolemic Hemodilution
This study will help enhance current understanding of the impact of Acute Normovolemic Hemodilution (ANH) administration on transfusion requirements post cardiac surgery, the effect of this procedure on coagulation, and platelet…
- Trial name
- TARGET-ANH (NCT03326323)
- Testing
- Acute Normovolemic Hemodilution
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- Inova Health Care Services
Acute Kidney Injury
Aminophylline to Prevent Acute Kidney Injury in Children After Cardiac Surgery
Children with congenital heart defects often need cardiac surgery with cardiopulmonary bypass (the "heart-lung machine"). Approximately 35 to 50% of these children will have "acute kidney injury," or damage to the kidneys, after…
- Trial name
- KIDPROAM (NCT01245595)
- Testing
- Aminophylline
- Where
- United States
- Volunteers
- 144 people
- Sponsor
- Stanford University
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)
Open-heart Surgery, Cardiopulmonary Bypass
Intravenous Phenoxybenzamine Use in Pediatric Patients Undergoing Open-Heart Surgery
Cardiopulmonary bypass is done with a machine that does the work of the heart and lungs during open-heart surgery. This study is to determine if intravenous (i.v.) phenoxybenzamine is safe.
- Trial name
- NCT00569855
- Testing
- Phenoxybenzamine
- Where
- United States
- Volunteers
- 785 people
- Sponsor
- University of Arkansas
Hemostasis
In Vivo Effects of Fibrinogen Concentrate (FC) Versus Cryoprecipitate on the Neonatal Fibrin Network Structure After Cardiopulmonary Bypass (CPB)
This primary aim of this study is to compare the in vivo effects of fibrinogen concentrate and cryoprecipitate on the neonatal fibrin network after surgery with cardiopulmonary bypass to develop effective and safe strategies for…
- Trial name
- NCT03932240
- Testing
- Fibrinogen Concentrate (FC), Cryoprecipitate
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Emory University
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
Cardiac Surgery, Cardiopulmonary Bypass
Colloids in Pediatric Cardiac Surgery: Comparison Between a Balanced and a Non-balanced Colloid
This study will compare the clinical efficacy and safety of Volulyte® and Voluven® during elective open-heart surgery in pediatric patients.
- Trial name
- COLCHIRCARD (NCT02584868)
- Testing
- Hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution, Hydroxyethyl starch 130/0.4 in 0.9% sodium chloride
- Where
- Belgium
- Volunteers
- 88 people
- Sponsor
- Queen Fabiola Children's University Hospital
Congenital Heart Surgery, Cardiopulmonary Bypass
Use of Phenoxybenzamine [PBZ] IV to Assist High Flow Low Pressure Perfusion [HFLPP] on Cardio-pulmonary Bypass
Cardiopulmonary bypass [CPB] in small size bodies can result in decreased peripheral perfusion. This results in anaerobic metabolism as evidenced by lactic acidosis.
- Trial name
- NCT00620945
- Testing
- Phenoxybenzamine
- Volunteers
- 87 people
- Sponsor
- The Cleveland Clinic
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
Cardiac Surgery Intensive Care Treatment, Delayed Recovery From Anaesthesia
Role of Levothyroxine Supplementation in Delayed Recovery Following Cardiac Surgery
Research indicates that hypothyroidism decreases heart contractility, reduces stroke volume and rate, affects the vascular endothelium, and increases the risk of atherosclerosis, systemic vascular resistance, hypertension…
- Conditions
- Cardiac Surgery Intensive Care Treatment, Delayed Recovery From Anaesthesia, Euthyroid Sick Syndrome, Cardiac Surgery Requiring Cardiopulmonary Bypass
- Trial name
- L-Thyroxine (NCT06660823)
- Testing
- L-thyroxine
- Where
- Egypt
- Volunteers
- 70 people
- Sponsor
- Ain Shams University
Thoracic Surgery, Cardiopulmonary Bypass
Cerebral Autoregulation Monitoring During Cardiac Surgery
Neurological complications from cardiac surgery are an important source of operative mortality, prolonged hospitalization, health care expenditure, and impaired quality of life.
- Trial name
- NCT00981474
- Testing
- blood pressure maintenance based on cerebral blood flow autoregulation measurement, Control group
- Where
- United States
- Volunteers
- 460 people
- Sponsor
- Northwestern University
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
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
Cardiopulmonary Bypass, Inflammation
Bradykinin Receptor Antagonism During Cardiopulmonary Bypass
Each year over a million patients worldwide undergo cardiac surgery requiring cardiopulmonary bypass (CPB). CPB is associated with significant morbidity including the transfusion of allogenic blood products, inflammation and…
- Conditions
- Cardiopulmonary Bypass, Inflammation, Fibrinolysis, Surgery
- Trial name
- BRAC (NCT00223704)
- Testing
- HOE 140, Aminocaproic Acid
- Where
- 2 sites in United States
- Volunteers
- 150 people
- Sponsor
- Vanderbilt University
Thoracic Aneurysm, Aneurysm Stent
The Effects of Anesthesia on Patients Undergoing Surgery for Repair of a Thoracoabdominal Aneurysm.
Alzheimer's disease represents a growing public health problem in developed countries. Although the pathogenesis is not clearly defined, accumulation of extracellular amyloid, neurofibrillary tangles and neuronal loss are the…
- Conditions
- Thoracic Aneurysm, Aneurysm Stent, Cardiopulmonary Bypass, Abdominal Aneurysm
- Trial name
- NCT01772537
- Testing
- Propofol, isoflurane
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Johns Hopkins University
Low T3 Syndrome
Can Oral T3 Normalize Thyroid Hormone Levels Following Cardiopulmonary Bypass in Children?
Low triiodothyronine (T3) syndrome defines as decrease of T3 levels during critically ill. This decrease of T3 levels was observed after congenital heart surgery using cardiopulmonary bypass.
- Trial name
- NCT01780584
- Testing
- Oral T3 Low dose, Oral T3 high dose
- Where
- Indonesia
- Volunteers
- 45 people
- Sponsor
- National Cardiovascular Center Harapan Kita Hospital Indonesia
Cardiopulmonary Bypass Surgery
Assessing the Hemostatic Efficacy of Pathogen Reduced Platelets in Children Undergoing Cardiopulmonary Bypass Surgery: A Pilot Clinical Trial
This study is testing whether pathogen reduced platelets can control bleeding as well as non-pathogen reduced platelets (otherwise known as large volume delayed sampling).
- Trial name
- PEDITREC (NCT05293106)
- Testing
- Platelet Transfusion
- Where
- 2 sites in United States
- Volunteers
- 9 people
- Sponsor
- Weill Medical College of Cornell 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
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
Pathologic Fibrinolysis
Fibrinolysis Before Cardiopulmonary Bypass?
It is common practice to use antifibrinolytic agents before and during cardiopulmonary bypass. They are not without side effects.
- Trial name
- NCT01981863
- Testing
- Epsilonaminocaproic acid
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Stanford University