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C.Surgical Procedure; Cardiac clinical trials

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NCT ID: NCT03913481 Recruiting - Clinical trials for C.Surgical Procedure; Cardiac

Acute Normovolemic Hemodilution in High Risk Cardiac Surgery Patients.

ANH
Start date: April 15, 2019
Phase: N/A
Study type: Interventional

Transfusions are one of the most overused treatments in modern medicine, and saving blood is one important issue all around the world. Cardiac surgery makes up a large percentage of the overall blood components consumption in surgery. Acute normovolemic hemo-dilution (ANH) is a well-known strategy which has been used for years without the support of high quality evidence based medicine to improve post-cardiopulmonary bypass coagulation and reduce red blood cells (RBC) transfusion. We designed a multicenter randomized controlled trial to investigate the effect of ANH in reducing the number of cardiac surgery patients receiving RBC transfusions during hospital stay. We will randomize 2000 patients to have sufficient power to demonstrate a 20% relative and 7% absolute risk reduction in the number of patients' RBC transfusion. If the results of the study will confirm our hypothesis, this will have a great impact on blood management in cardiac operating room.

NCT ID: NCT03884725 Recruiting - Clinical trials for Blood Coagulation Disorders

Fibrinogen Concentrate In Children Cardiac Surgery 2

FiCCS2
Start date: March 1, 2019
Phase: Phase 4
Study type: Interventional

The purporse of this study is evaluate whether fibrinogen concentrate reduces postoperative bleeding in pediatric cardiac surgery with cardiopulmonary by-pass.

NCT ID: NCT03882593 Recruiting - Clinical trials for Blood Coagulation Disorders

Blood Cell Adhesion to Arterial Filters During Cardiac Surgery

Start date: August 30, 2018
Phase:
Study type: Observational

Cardiopulmonary bypass (CPB) is a unique clinical scenario that results in widespread activation of the hemostatic system. Conventional CPB interferes with normal hemostasis by diluting hemostatic cells and proteins, through reinfusion of shed blood, and through activation on the bypass circuit surface of multiple systems including platelets, the kallikrein-kinin system, and fibrinolysis . Besides, deleterious effects of cardiopulmonary bypass (CPB) are partly sequelae of blood-foreign surface reactions. The arterial filter is the part of the CPB circuit where blood cells are exposed to high mechanical stress and where cellular aggregates may fasten in large quantitiesiec.

NCT ID: NCT03469440 Recruiting - Clinical trials for C.Surgical Procedure; Cardiac

Goal Directed Therapy Aiming to Optimise Oxygen Central Venous Saturation in Children Undergoing Cardiac Surgery

Start date: February 1, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is evaluate goal-directed therapy with continuous central venous saturation compared to standard therapy in children undergoing cardiac surgery.

NCT ID: NCT03343418 Active, not recruiting - Clinical trials for Blood Coagulation Disorders

Effects of Prophylactic Desmopressin on Blood Coagulation Parameters in Heart Valve Surgery

Start date: February 2015
Phase: Phase 4
Study type: Interventional

The purpose of this study is evaluate the effect of prophylactic desmopressin on blood coagulation parameters and postoperative bleeding in patients undergoing valve cardiac surgery with cardiopulmonary bypass.

NCT ID: NCT02972684 Completed - Blood Transfusion Clinical Trials

Cost-Utility Analysis of Management of Peri Operative Haemorrhage Following Cardiac Surgery With Cardiopulmonary Bypass

IMOTEC
Start date: January 3, 2017
Phase: N/A
Study type: Interventional

Peri operative haemorrhage following cardio Pulmonary Bypass may occur in 5 to 10% of cardiac surgical interventions. Treatment of such complication often necessitates various combinations therapeutic intervention including allogenic blood products administration, drug use and/or surgical intervention. All are expensive treatment and decision making is guided by patient clinical status and biological tests of the haemostatic function. A key point is the time frame of the clinical process. Therapeutic choices have to be done as fast as possible to minimize bleeding consequences on patient haemodynamic and physiological status. Conventional coagulation test results availability time usually exceed 45' after blood drawing. In such situation, the results may not reflect precisely the coagulation system current state. This downside is often counterbalanced by clinicians empirical choices preceding lab test results knowledge that may conduct to inappropriate treatment, blood product overuse and undue expense. Viscoelastic point of care test may compensate for the limitations of conventional coagulation tests. In perioperative haemorrhage, faster and more precise information about haemostatic function may help for more accurate therapeutic choices. The IMOTEC study aims to compare haemorrhage management following cardiac surgery using conventional blood coagulation tests or thrombo-elastogaphic point of care test. Primary endpoint is a cost utility analysis of the technology and secondary endpoints include blood component transfusion, postoperative bleeding , thoracic re-intervention, postoperative infection (any cause), organ failure, in hospital length of stay and death.

NCT ID: NCT02908009 Recruiting - Clinical trials for C.Surgical Procedure; Cardiac

A Case Control Study to Identify the Role of Epigenetic Regulation of Genes Responsible for Energy Metabolism and Mitochondrial Function in the Obesity Paradox in Cardiac Surgery

Ob-Card
Start date: September 9, 2016
Phase:
Study type: Observational

This is a prospective, single-centre case control comparison of expression of target genes responsible for energy utilisation, mitochondrial function and oxidative stress and levels of histone acetylation/ DNA methylation in obese and non-obese adult cardiac surgery patients. The study aims to test several inter-related hypotheses in a consecutive sequence of patients undergoing coronary artery bypass grafting.

NCT ID: NCT02866825 Completed - Clinical trials for Systemic Inflammatory Response Syndrome

Studying Complement Inhibition in Complex Cardiac Surgery

CARDIAC
Start date: May 2016
Phase: Phase 2
Study type: Interventional

The trial enrolls patients undergoing a complex cardiac surgery. The primary goal of the trial is to evaluate the pharmacodynamic dose response relationship of the monoclonal antibody IFX-1 in these patients. In addition, this trial further aims to characterize the safety and the pharmacokinetics of IFX-1 as well as to collect first data on its efficacy on clinical surrogate endpoints.

NCT ID: NCT02831907 Completed - Acute Kidney Injury Clinical Trials

Portal Flow Pulsatility as a Risk Factor for Acute Kidney Injury After Cardiac Surgery

PP-AKI
Start date: August 2016
Phase: N/A
Study type: Observational

The purpose of this study is to evaluate the possible association between portal vein flow pulsatility and acute kidney injury after cardiac surgery. Participants will undergo assessment of portal vein flow and intra-renal blood flow using bedside Doppler ultrasound before surgery and daily for three days after cardiac surgery.

NCT ID: NCT02793895 Terminated - Atrial Fibrillation Clinical Trials

Detection of Atrial Fibrillation After Cardiac Surgery

SEARCH-AF
Start date: February 24, 2017
Phase: N/A
Study type: Interventional

The aim of the SEARCH-AF trial is to evaluate a novel diagnostic tool for detecting post-operative atrial fibrillation or flutter (POAF/AFL) in cardiac surgical subjects during the early, sub-acute post-operative period. The population includes cardiac surgical subjects who have either developed or are at risk for developing new onset POAF/AFL and who are at risk for stroke, as determined by their CHA2DS2-VASC (congestive heart failure, hypertension, age ≥75 years (2 points), diabetes mellitus, previous stroke/transient ischemic attack (TIA) (2 points), vascular disease, age 65-74 years, sex class (female)) score. These subjects must not have had a history of AF/AFL before cardiac surgery. The intervention group will undergo up to 30 days of continuous cardiac rhythm monitoring with an adhesive, patch-based monitor (Medtronic SEEQ™ mobile cardiac telemetry system or the CardioSTAT (Icentia Inc.) cardiac rhythm monitoring device). The control group will receive usual care, which does not involve planned cardiac rhythm testing within the first 30 days after study randomization. The primary outcome is documentation of sustained atrial fibrillation or flutter within the first 30 days after randomization. In addition, subjects in both groups will undergo 14 days of continuous cardiac rhythm monitoring with the Medtronic SEEQ™ mobile cardiac telemetry system or the CardioSTAT (Icentia Inc.) cardiac rhythm monitoring device at 6±1 months after their index cardiac surgery.