Clinical trials: Cardiac Surgery in Adult Patient
Bleeding Cardiac Surgery Patients
Active-control Randomized Trial Comparing 4-factor Prothrombin Complex Concentrate With Frozen Plasma in Cardiac Surgery
This is a multicenter, active-control randomized, prospective, Phase 3 study in adult cardiac surgery patients. 420 patients were randomized at 12 hospitals.
- Trial name
- FARES-2 (NCT05523297)
- Testing
- Octaplex, Frozen Plasma Product, Human
- Where
- 13 sites in United States, Canada
- Volunteers
- 420 people
- Sponsor
- Octapharma
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.
Cerebral Stroke, Thrombosis, Deep Vein
A Study of Adverse Events and Suspected Adverse Drug Reactions in Patients Under Apixaban for Prevention of Stroke and Systemic Embolism With Non-Valvular Atrial Fibrillation and Venous Thromboembolic Events in Patients Who Have Undergone Elective Hip or Knee Replacement Surgery
To characterize and analyze the number, type and incidence of adverse events/suspected adverse drug reactions in patients treated with Apixaban, according to therapeutic indications approved in Mexico.
- Conditions
- Cerebral Stroke, Thrombosis, Deep Vein, Pulmonary Embolism
- Trial name
- NCT03804125
- Sponsor
- Pfizer
Myocardial Ischemia
Safety & Efficacy of Adipose-Derived Regenerative Cells in the Treatment of Chronic Myocardial Ischemia (ATHENA II)
This is a prospective, randomized, placebo-controlled, double blind safety and efficacy clinical trial.
- Trial name
- ATHENA II (NCT02052427)
- Testing
- Celution System
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Cytori Therapeutics
Heart; Dysfunction Postoperative, Cardiac Surgery
VolulyteTM in Cardiac Surgery
The study will compare the efficacy and safety of VolulyteTM and human albumin in elective open-heart surgery in adult patients.
- Trial name
- NCT01553617
- Testing
- 6% hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (VolulyteTM), Human serum albumin
- Where
- 5 sites in Canada
- Volunteers
- 133 people
- Sponsor
- Fresenius Kabi
Anesthesia
Study of the Efficacy and Safety of Remimazolam in General Anesthesia in Adults Undergoing Cardiac Surgery
This study investigates the use of remimazolam as a sedative/hypnotic in general anesthesia. Remimazolam or propofol will be administered together with fentanyl/sufentanil/remifentanil as opioid analgesics and a neuromuscular…
- Trial name
- NCT02523859
- Testing
- Propofol, Remimazolam
- Where
- Germany
- Volunteers
- 25 people
- Sponsor
- Paion UK Ltd.
Myocardial Ischemia
Safety and Feasibility Trial of Adipose-Derived Regenerative Cells in the Treatment of Chronic Myocardial Ischemia
This is a prospective, randomized, placebo-controlled, double blind safety and feasibility clinical trial.
- Trial name
- ATHENA (NCT01556022)
- Testing
- ADRCs processed by the Celution System
- Where
- 8 sites in United States
- Volunteers
- 28 people
- Sponsor
- Cytori Therapeutics
Acute Kidney Injury Following Cardiac Surgery
A Multi-center Study to Evaluate the Safety, Tolerability and Efficacy of TIN816 in Patients at Risk for Acute Kidney Injury Following Cardiac Surgery.
This was a randomized, multi-centric, placebo-controlled, participant and investigator-blinded study to evaluate the safety, tolerability and efficacy of TIN816 in adult patients at risk for acute kidney injury following cardiac…
- Trial name
- NCT05524051
- Testing
- TIN816
- Where
- 37 sites in United States, Argentina and 13 more
- Volunteers
- 102 people
- Sponsor
- Novartis Pharmaceuticals
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
General Anesthesia
Remimazolam Phase II Cardiac Anesthesia Study
This phase II study in patients undergoing elective cardiac surgery will evaluate the efficacy, safety, and pharmacokinetics of remimazolam, compared with propofol and sevoflurane, during the induction and maintenance of general…
- Trial name
- NCT01937767
- Testing
- Remimazolam, Propofol, Sevoflurane
- Where
- Germany
- Volunteers
- 90 people
- Sponsor
- Paion UK Ltd.
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 Artery Disease
A Study of Anginera In Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery
This is a first in man, Phase I safety study of Anginera in adults with Left Ventricular Dysfunction (LVD) and Reversible Myocardial Ischemia undergoing a CABG procedure.
- Trial name
- NCT00364390
- Testing
- Anginera, a human tissue replacement therapy
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Theregen, Inc.
Blood Loss, Surgical
Pre-surgical Evaluation for the Quantra System in Adult Patients Undergoing Cardiac Surgery
This study will evaluate the performance of the Quantra System comprised of the Quantra Hemostasis Analyzer with the QPlus Cartridge in patients taking anitplatelet medication that are scheduled to undergo cardiac surgery.
- Trial name
- NCT03931031
- Testing
- Quantra System
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- HemoSonics LLC
Intensive Care Unit, Coronary Artery Bypass Grafting (CABG)
Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients
The MODIFY CSX study is a prospective, randomized, placebo-controlled trial conducted in heart centers in Germany and Italy. A total of 550 high-risk cardiac surgery patients will receive either 0.20 g fish oil/kg body weight…
- Conditions
- Intensive Care Unit, Coronary Artery Bypass Grafting (CABG), High Risk Patients, Cardiopulmonary Bypass
- Trial name
- MODIFY CSX (NCT06279793)
- Testing
- Fish Oil, Intravenous 0.9% Sodium Chloride
- Where
- 10 sites in Germany
- Volunteers
- 550 people
- Sponsor
- GCP-Service International West GmbH