Clinical trials: Postoperative Cardiac Surgery
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
Postoperative Wound Infection Superficial Incisional, Postoperative Wound Infection Deep Incisional Surgical Site
Safety and Efficacy of D-PLEX in the Prevention of Sternal Infection Post Cardiac Surgery.
This study is aimed to assess the anti-infective efficacy of D-PLEX over a period of 3 months post operation as well as the safety over a period of 6 months, by preventing sternal infection post cardiac surgery in patients above…
- Trial name
- NCT02731573
- Testing
- D-PLEX, Open heart surgery
- Where
- 5 sites in Israel
- Volunteers
- 81 people
- Sponsor
- PolyPid Ltd.
Ventilator-Induced Diaphragm Dysfunction
Study of TransAeris® System for Enhanced Recovery After Surgery in France
This study will be conducted as a randomized trial of the TransAeris system for the prevention and treatment of ventilator-induced diaphragm dysfunction (VIDD) in patients identified prior to surgery to be at greater risk of…
- Trial name
- ERAS (NCT05404477)
- Testing
- TransAeris System
- Where
- France
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Synapse Biomedical
Cardiac Disease, Myocardial Dysfunction
Temporary Epicardial Pace Wire With Integrated Sensor for Continuous Postoperative Monitoring of Myocardial Function
Transesophageal echocardiography is used to monitor cardiac wall motion at various time points during open-heart surgery. After surgery, the measurements are made at various time points by transthoracic echocardiography.
- Trial name
- NCT04886934
- Testing
- CS1 System
- Where
- Norway
- Volunteers
- 38 people
- Sponsor
- Cardiaccs AS
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
Cardiac Surgery, Bone Wax, NU-KNIT, Median Sternotomy, Deep Sternal Wound Infection, Surgical Site Infection
Surgicel NU-KNIT Vs Bone Wax on Median Sternotomy
Bone wax is traditionally used as part of surgical procedures to prevent bleeding from exposed spongy bone. It is an effective hemostatic device which creates a physical barrier.
- Trial name
- NBCS (NCT06869772)
- Testing
- Closure of sternotomy
- Where
- Qatar
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Hamad Medical Corporation
Hemorrhage, Surgical, Blood Loss, Surgical
Safe and Timely Antithrombotic Removal - Ticagrelor (STAR-T)
Prospective, multi-center, double-blind, randomized pivotal trial to evaluate the safety and effectiveness of the DrugSorb-Antithrombotic Removal (ATR) system for intraoperative removal of ticagrelor in patients undergoing urgent…
- Conditions
- Hemorrhage, Surgical, Blood Loss, Surgical, Blood Loss, Postoperative, Hemorrhage Postoperative
- Trial name
- STAR-T (NCT04976530)
- Testing
- DrugSorb-ATR system
- Where
- 29 sites in United States, Canada
- Volunteers
- 140 people
- Sponsor
- CytoSorbents, Inc
Post Cardiac Surgery, Sternal Closure
TORQ Clinical Study
The proposed trial is to evaluate the use of the TORQ closure assistance device and how it affects pain in the sternum, breathing and quality of life compared to traditional use of needle drivers or similar to close sternal wires.
- Trial name
- TORQClin (NCT01647178)
- Testing
- TORQ assisted sternal closure, Conventional closure
- Where
- Canada
- Volunteers
- 92 people
- Sponsor
- Kardium Inc.
Acquired Antithrombin III Deficiency, Coronary Artery Bypass
Use of Antithrombin in Cardiac Surgery With Cardiopulmonary Bypass
The purpose of this trial is to study the effects of preoperative antithrombin supplementation in patients undergoing cardiac surgery with cardiopulmonary bypass in order to maintain antithrombin levels in a range greater than…
- Trial name
- NCT00823082
- Testing
- Antithrombin III
- Where
- Italy
- Volunteers
- 200 people
- Sponsor
- Instituto Grifols, S.A.
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
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
Systemic Inflammatory Response Syndrome, Acute Kidney Injury
High Cut Off Dialysis in Systemic Inflammatory Response Syndrome Patients After Cardiac Surgery
A high cut off dialyzer (septeX) is tested in patients after cardio-thoracic surgery with incidence of "systemic inflammatory response syndrome" (SIRS) and associated increased risk for acute kidney injury (AKI).
- Trial name
- HICOSIRS (NCT01579396)
- Testing
- septeX, standard therapy
- Where
- Germany
- Sponsor
- Vantive Health LLC
Cardiac Disease, Multiple Organ Dysfunction Syndrome
Efferon LPS Hemoadsorption in Cardiac Surgery Patients
This randomized controlled study aims to evaluate the efficacy and safety of intraoperative and early postoperative hemoadsorption using the Efferon® LPS device in patients undergoing cardiac surgery with cardiopulmonary bypass…
- Trial name
- NCT07532174
- Testing
- Efferon LPS
- Where
- 3 sites in Russia
- Volunteers
- 60 people
- Sponsor
- Efferon JSC
Critical Illness
Blood Glucose Control Over an Extended Glucose Control Range in Postoperative Cardiac Surgery Patients in the Intensive Care Unit
Hyperglycaemia is commonly found in critically ill patients. Clinical studies demonstrated that tight blood glucose control in medical and surgical ICU patients results in a significant better outcome for the patients.
- Trial name
- Aldea_02 (NCT00882427)
- Testing
- enhanced model predictive control algorithm (eMPC)
- Where
- United Kingdom
- Volunteers
- 20 people
- Sponsor
- B. Braun Melsungen AG
Cardiac Surgical Patients (CABG,Mammary Coronary Bypass Surgery,Plastic and Replacement of Valves, Atrial Septal Defect,Ventricular Septal Defect)
Evaluation of the Effectiveness and Safety of Vibro-acoustic Pulmonary Therapy (VAPT) in Complex Therapy for Acute Respiratory Failure of Mixed Type I-II Stages in Comparison With Percussion Massage in Cardiac Surgical Patients in the Early Postoperative Period
The goal of this observational study is to evaluate the effectiveness and safety of vibro-acoustic pulmonary therapy (VAPT) in complex therapy for the acute respiratory failure of mixed type I-II stages in comparison with…
- Trial name
- NCT06320483
- Testing
- Vibroacoustic device BARK VibroLUNG
- Where
- 5 sites in Kazakhstan
- Volunteers
- 310 people
- Sponsor
- Bark Technology LLP
Hypertension
Study of Clevidipine Assessing Its Postoperative Antihypertensive Effect in Cardiac Surgery (ESCAPE-2)
The purpose of this study is to establish the efficacy of of clevidipine versus placebo in treating postoperative hypertension. Approximately 100 patients with postoperative hypertension undergoing coronary artery bypass grafting…
- Trial name
- ESCAPE-2 (NCT00093262)
- Testing
- clevidipine
- Where
- 15 sites in United States
- Volunteers
- 206 people
- Sponsor
- The Medicines Company
Heart Diseases, Postoperative Complications
A Trial of INO-1001 in Patients Undergoing Heart Surgery That Involves Heart-lung Bypass
The purpose of this study is to assess the safety of INO-1001, an intravenous PARP (poly-[ADP ribose] polymerase) inhibitor, in patients undergoing heart surgery.
- Trial name
- NCT00271167
- Testing
- INO-1001
- Where
- 13 sites in United States, Australia and 2 more
- Volunteers
- 162 people
- Sponsor
- Inotek Pharmaceuticals Corporation
Post Operative Pain, Midline Sternotomy Incision
Percutaneous Electrical Nerve Stimulation (PENS) of the Auricle for Post Operative Pain Solution(POPS) - Cardiac Surgery
Percutaneous Electrical Nerve Stimulation (PENS) of the auricle for acute pain management post cardiac surgery
- Trial name
- POPS (NCT03750357)
- Testing
- Primary Relief v 2.0
- Where
- India
- Volunteers
- 60 people
- Sponsor
- DyAnsys, Inc.
Post-Operative Complications in Cardiac Surgery
An Evaluation of Patient Reported Outcomes and Clinical Outcomes
This extension study is being conducted to assess the following objectives through 12 months post-cardiac surgery: Patient reported outcomes (PRO), using the EQ-5D questionnaire Clinical outcomes
- Trial name
- NCT06092970
- Testing
- RBT-1
- Where
- 39 sites in United States, Canada
- Volunteers
- 353 people
- Sponsor
- Renibus Therapeutics, Inc.
Postoperative Pain
Study to Evaluate the Pharmacokinetics and Safety of EXPAREL for Postoperative Analgesia in Subjects Undergoing Cardiac Surgery
This Phase 1, multicenter, open-label, randomized, bupivacaine-controlled study is designed to evaluate the pharmacokinetics (PK) and safety of EXPAREL vs.
- Trial name
- NCT06271265
- Testing
- EXPAREL, bupivacaine
- Where
- 5 sites in United States
- Volunteers
- 48 people
- Sponsor
- Pacira Pharmaceuticals, Inc