Clinical trials: Open-heart Surgery
Cardiac Surgery, Cardiopulmonary Bypass
Voluven® in Paediatric Patients
This study will compare the clinical efficacy and safety of Voluven® and Human Albumin during elective open-heart surgery in pediatric patients.
- Trial name
- NCT00860405
- Testing
- HES 130/0.4 (6%) in sodium chloride (Voluven®, solution for infusion), Human serum albumin (HSA 50g/L), Human serum albumin (HSA 50g/L)
- Where
- 2 sites in Austria, Belgium
- Volunteers
- 61 people
- Sponsor
- Fresenius Kabi
Myocardial Injury
Study of Ticagrelor Versus Aspirin Treatment in Patients With Myocardial Injury Post Major Non-cardiac Surgery
The purpose of this pilot study is to establish the rate of cardiovascular events in patients with elevated troponins levels after major, non-cardiac surgery and to evaluate the efficacy and safety of FDA approved study drug…
- Trial name
- INTREPID (NCT02291419)
- Testing
- ticagrelor, aspirin
- Where
- 24 sites in United States
- Volunteers
- 6 people
- Sponsor
- The Cleveland Clinic
Open Heart Surgery
Ilofotase Alfa for Prevention of Renal Damage After Cardiac Surgery
The aim of this clinical trial is to evaluate the efficacy and safety of two intravenous administrations of ilofotase alfa in patients at risk for renal damage following open heart surgery.
- Trial name
- NCT06168799
- Testing
- Ilofotase alfa
- Where
- 13 sites in Belgium, Germany and 3 more
- Volunteers
- 271 people
- Sponsor
- AM-Pharma
Congenital Heart Defects
Assessing the Hemodynamic Benefits of Cardiac Resynchronization Therapy in Children Following Open-Heart Surgery
Malformations of the heart (congenital heart disease) are the most common congenital birth defects, occurring in about 1% of children.
- Trial name
- NCT00397514
- Testing
- Congenital Heart Surgery Patients
- Where
- Canada
- Volunteers
- 34 people
- Sponsor
- University of British Columbia
Congenital Heart Disease
Study of Possible Brain Hormone Problems After Open Heart Surgery in Infants
The goal of this study is to evaluate specific hormone levels in children undergoing heart surgery in order to identify patterns associated with any unstable vital signs.
- Trial name
- NCT00850720
- Testing
- Blood draws
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Emory University
Coronary Artery Bypass Graft Surgery, Presence of Heparin/Platelet Factor 4 Antibody
Significance of Antibodies to Heparin/Platelet Factor 4 Complex in Vein Graft Patency and Potential Role of Argatroban for Prevention of Vein Graft Occlusion
Heparin/Platelet Factor 4 (PF4) antibody testing will be performed in subjects who have just undergone coronary artery bypass grafting (CABG) surgery.
- Trial name
- NCT01246011
- Testing
- Argatroban and warfarin
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Massachusetts General Hospital
Controlling Mild to Moderate Bleeding During Surgery
The EVARREST® Pediatric Mild or Moderate Liver and Soft Tissue Bleeding Study
The objective of this study is to evaluate the safety and hemostatic effectiveness of EVARREST as an adjunct to controlling mild to moderate soft hepatic parenchyma or soft tissue bleeding during open hepatic, abdominal, pelvic…
- Trial name
- NCT03255174
- Testing
- EVARREST® Fibrin Sealant Patch
- Where
- 5 sites in United States, United Kingdom
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Ethicon, Inc.
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
Hypoplastic Left Heart Syndrome, Total Anomalous Pulmonary Venous Return
Targeting Normoxia in Neonates With Cyanotic Congenital Heart Disease in the Intra-operative and Immediate Post-operative Period
This clinical trial is studying the use of different levels of oxygen exposure during and after cardiopulmonary bypass in eligible infants to learn about its safety during heart surgery.
- Conditions
- Hypoplastic Left Heart Syndrome, Total Anomalous Pulmonary Venous Return, Truncus Arteriosus, Pulmonary Atresia With Ventricular Septal Defect
- Trial name
- T-NOX (NCT04452188)
- Testing
- Normoxia (with controlled re-oxygenation), Standard of care ventilation
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- University of Michigan
Heart Diseases, Hyperglycemia
Remifentanil and Glycemic Response in Cardiac Surgery
This study evaluates the effect of using remifentanil during cardiopulmonary bypass surgery to supress the hyperglycemic response in perioperative period.
- Trial name
- NCT02349152
- Testing
- Remifentanil, Fentanyl
- Where
- United States
- Volunteers
- 116 people
- Sponsor
- Kathirvel Subramaniam
Arrhythmia
Effect of Colchicine on the Incidence of Atrial Fibrillation in Open Heart Surgery Patients
This study evaluates the role of colchicine in the prevention of atrial fibrillation in patients undergoing open heart surgery. Half of participants will receive colchicine and the other half will not
- Trial name
- END-AF (NCT03021343)
- Testing
- Colchicine
- Volunteers
- 360 people
- Sponsor
- Jordan Collaborating Cardiology Group
Cardiac Disease, Cardiac Surgery
Platelet Transfusion During Neonatal Open Heart Surgery
Hypothesis: Dilutional thrombocytopenia after cardiopulmonary bypass (CPB) is universal and administration of donor apheresis platelets just prior to termination of bypass will assist in early correction of coagulopathy, early…
- Conditions
- Cardiac Disease, Cardiac Surgery, Cardiopulmonary Bypass, Platelet Transfusion
- Trial name
- CPB (NCT03045068)
- Testing
- Platelet Transfusion, FFP and Cryoprecipitate, PRBC and cell saver Transfusion
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- The University of Texas Health Science Center, Houston
Surgery, Pneumonia
Multicenter Infection Surveillance Study Following Open Heart Surgery
The main goals of the study are as follows: (1) to determine the correlation between pain management using continuous infusion of local anesthetics and the incidence of pneumonia and surgical infection in cardiac surgery…
- Conditions
- Surgery, Pneumonia, Surgical Site Infection
- Trial name
- NCT00673712
- Testing
- Continuous Sternal Block, Opioid based analgesia
- Where
- 8 sites in United States
- Volunteers
- 647 people
- Sponsor
- Halyard Health
Post-Operative Atrial Fibrillation
Botulinum Toxin Type A (AGN-151607) for the Prevention of Post-operative Atrial Fibrillation in Adult Participants Undergoing Open-chest Cardiac Surgery (NOVA)
This was a multi-center, randomized, double-blind, placebo-controlled, parallel group, dose-ranging study to evaluate the efficacy and safety of botulinum toxin type A (AGN-151607) injections into the epicardial fat pads, foci of…
- Trial name
- NCT03779841
- Testing
- AGN-151607
- Where
- 32 sites in United States, Austria and 7 more
- Volunteers
- 323 people
- Sponsor
- AbbVie
Coronary Disease
Obtain Additional Information on Use of CorMatrix ECM (Extracellular Matrix)
The objective of the study is to actively gather additional information on the use of CorMatrix ECM for pericardial reconstruction.
- Trial name
- RECON (NCT02073331)
- Where
- 43 sites in United States
- Volunteers
- 1,420 people
- Sponsor
- Elutia Inc.
Atrial Fibrillation, Atrial Flutter
Prophylaxis to Reduce Postoperative Atrial Fibrillation in Cardiac Surgery
Atrial Fibrillation (AF) is a common postoperative complication of cardiac surgery, occuring in approximately 25-30% of coronary artery bypass graft (CABG) patients and 35-40% of heart valve repair/replacement patients.
- Trial name
- NCT00953212
- Testing
- beta blockers, amiodarone, ascorbic acid
- Where
- United States
- Volunteers
- 304 people
- Sponsor
- MaineHealth
Pain
A Study of Sternal Closure After Open Heart Surgery: Rigid Versus Wire Closure
The investigators are conducting this research to compare two different methods of closure of the sternum after cardiac surgery to determine if one method is better than the other.
- Trial name
- NCT01317095
- Testing
- Sternalock Rigid Fixation
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Thomas Jefferson University
Bleeding, Surgical Blood Loss
DEPOSITION - Decreasing Postoperative Blood Loss by Topical vs. Intravenous Tranexamic Acid in Open Cardiac Surgery
The aim is to conduct a double-dummy multi-centre randomized controlled clinical trial of application of topical dose of tranexamic acid (TxA) versus the usual intravenous TxA in patients undergoing on-pump cardiac surgery.
- Conditions
- Bleeding, Surgical Blood Loss, Seizures
- Trial name
- DEPOSITION (NCT03954314)
- Testing
- Tranexamic Acid
- Where
- 16 sites in Canada, China and 4 more
- Volunteers
- 3,242 people
- Sponsor
- Population Health Research Institute
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
Open Heart Surgery
Closed Loop Isoflurane Administration With Bispectral Index in Open Heart Surgery
With the advancement in microprocessor technology and better understanding of pharmacodynamics and pharmacokinetics of anaesthetic agents, computer facilitated closed loop control of anaesthesia using propofol has been shown to…
- Trial name
- NCT01069562
- Testing
- Conventional control, Closed loop control
- Where
- India
- Volunteers
- 40 people
- Sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh