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Cardiopulmonary Bypass clinical trials

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NCT ID: NCT06279793 Recruiting - Cardiac Surgery Clinical Trials

Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients.

MODIFYCSX
Start date: February 15, 2024
Phase: Phase 2
Study type: Interventional

The proposing study is a randomized, double-blind, controlled trial of about 120 patients in 10 centers in Germany. This trial will be started in Germany and recruited mainly at powerful German heart centers only. In this prospective randomized controlled blinded multicenter trial, a total of 120 high-risk cardiac surgery patients will receive either standard of care + OMEGAVEN at 0.20 g/kg ideal body weight (IBW) versus placebo + standard of care.

NCT ID: NCT06159517 Recruiting - Cardiac Surgery Clinical Trials

Heart Lung Machine Registry

HeaLMe
Start date: December 21, 2023
Phase:
Study type: Observational

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 cardiac / thoracic / vascular surgery.

NCT ID: NCT06109155 Recruiting - Clinical trials for Cardiopulmonary Bypass

The Effect of ACT and Tranexamic Acid on Bleeding in Cardiac Surgery

Start date: February 8, 2024
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial is to the dose effect of tranexamic acid and the level of ACT on bleeding in adult cardiac surgery. The main questions it aims to answer are: 1. Does higher dose of tranexamic acid reduce the amount of bleeding and blood transfusion? 2. Does lower ACT level during cardiac surgery reduce the amount of bleeding and blood transfusion? Participants will divided into four groups which have different tranexamic acid dose and ACT level during cardiac surgery to see if there is any different in the amount of bleeding and blood transfusion.

NCT ID: NCT05927233 Recruiting - Clinical trials for Cardiopulmonary Bypass

Effect of Methylprednisolone on Systemic Inflammatory Response During Pediatric Congenital Open-Heart Surgery

Start date: April 1, 2023
Phase: Phase 4
Study type: Interventional

The goal of this study is to evaluate the effects of steroids on the early postoperative inflammatory response in patients undergoing elective pediatric congenital cardiac surgery, requiring cardiopulmonary bypass (CPB).

NCT ID: NCT05746559 Recruiting - Clinical trials for Chronic Kidney Disease

ARTEMIS: Ravulizumab to Protect Patients With CKD From CSA-AKI and MAKE

ARTEMIS
Start date: April 6, 2023
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to assess the efficacy of a single dose of ravulizumab IV compared with placebo in reducing the risk of the clinical consequences of AKI (MAKE) at 90 days in adult participants with CKD who undergo non-emergent cardiac surgery with CPB.

NCT ID: NCT05740059 Recruiting - Cardiac Surgery Clinical Trials

Restrictive Transfusion StratEgy Adjusted by SvO2 During Cardiac Surgery

RETSEACSII
Start date: March 14, 2023
Phase: N/A
Study type: Interventional

The goal of the clinical trial is to evaluate whether a restrictive transfusion strategy adjusted by SvO2 during the perioperative period of cardiac surgery may reduce the incidence of red blood cell transfusion. Adult patients operated on cardiac surgery will be randomly allocated into two groups, one receiving standard restrictive transfusion, the other receiving SvO2 adjusted restrictive transfusion.The proportion of patients transfused will be compared between the 2 groups.

NCT ID: NCT05685537 Recruiting - Cardiac Surgery Clinical Trials

Impact of Levosimendan Preconditioning on Critical Care and In-hospital Lengths of Stay After Cardiac Surgery With Bypass Surgery

LevoCCV
Start date: December 15, 2022
Phase:
Study type: Observational

Levosimendan, a drug with inotropic, vasodilatory and myocardial protective properties, has been proposed for the prevention and treatment of postoperative low cardiac output syndrome in cardiac surgery. Despite preliminary studies with promising results, large randomized controlled trials aimed at demonstrating the benefits of levosimendan did not show superiority over placebo in this indication. However, in these studies, the infusion was neither performed at the maximum dosage nor during the 24 hours preceding the surgery, but mainly at the very beginning of the operation. However, post hoc analyses showed a reduction in mortality and in the occurrence of low cardiac output syndrome in the subgroup of patients who had undergone isolated coronary artery bypass grafting, in contrast to those who had undergone valvular or combined surgery. Another recent study suggests that under similar conditions, preconditioning with levosimendan started 48 hours before surgery reduces the length of stay in intensive care and the average cost of hospitalization. There are no formal recommendations on the prophylactic use of levosimendan in cardiac surgery for heart failure patients with impaired LVAS. However, the France-Levo registry, a multicenter observational study requested by the HAS, has shown that in real practice there is a place for preconditioning with levosimendan, which is used in this indication for 7% of the patients in the registry. The Cardiovascular Surgery and Transplantation Department of the Nancy Brabois University Hospital, which actively participated in the France-Levo registry, is one of the cardiac surgery centers that uses this practice, as is the University Hospital of Rouen. It is interesting to be able to evaluate retrospectively whether levosimendan preconditioning has a positive impact on the postoperative prognosis of patients and more particularly on the reduction of the length of stay in critical care and in hospital compared to standard management.

NCT ID: NCT05588011 Recruiting - Clinical trials for Cardiopulmonary Bypass

Influence of Oxygenator Selection on Platelet Function and Rotational Thromboelastometry Following Cardiopulmonary Bypass

Start date: October 7, 2022
Phase: N/A
Study type: Interventional

Open-heart surgery requires temporarily stopping the heart and lungs and diverting the patient's blood to an outside system that takes over the function of the heart and lungs. This is possible through the use of cardiopulmonary bypass (CPB) which diverts blood, through plastic tubing, to a heart-lung machine which includes an oxygenator. The external oxygenator works as an artificial lung. This allows cardiac surgeons to operate in a field that is free of blood, while the patient's body continues to receive healthy blood. CPB is an advanced medical technology that allows for heart surgeries, such as coronary artery bypass, heart valve surgery, and procedures involving major blood vessels. It is recognized that there are many risks associated with its use, including microscopic stress exerted on blood components by the oxygenator and tubing, which can lead to irreversible damage to the blood cells. This effect can contribute to bleeding during and after surgery. This type of bleeding can be difficult to monitor and treat, especially given the limited access to point-of-care blood testing to inform clinicians on what part of the blood is failing to function properly. The investigators will use a point-of-care machine called Plateletworks to test the function of platelets during surgeries which require CPB. Platelets are an important part of blood that help stop bleeding by forming clots. At the investigators' institution two oxygenators are currently used interchangeably. These oxygenators have different properties that may impact how platelets function. This project will help determine if using a higher pressure oxygenator increases the risk of patients bleeding. Additionally, the investigators will compare the platelet data from Plateletworks to data collected from rotational thromboelastometry (ROTEM). This will yield valuable data about commonly used oxygenators and tests which can ultimately improve patient care.

NCT ID: NCT05487469 Recruiting - Immunotherapy Clinical Trials

Thymosin α1 Use in Rheumatic Heart Disease Patients Undergoing Cardiac Surgery on Cardiopulmonary Bypass

Start date: July 1, 2022
Phase: N/A
Study type: Interventional

Rheumatic heart disease usually accompanied by weakened immune function. And the cardiopulmonary bypass further aggravating the decline of immune function. Therefore, the prevention of Postoperative immune function collapse is of great clinical value, and immunomodulatory therapy with thymosin alpha 1 may be beneficial. This study was designed to test the hypothesis that the administration of thymosin alpha 1 will Improve the immune function and prognosis of patients.

NCT ID: NCT05189262 Recruiting - Cardiac Surgery Clinical Trials

Cardiopulmonary Bypass Induced Red Blood Cell Lysis

Start date: March 22, 2022
Phase:
Study type: Observational

Studying the dynamics of red blood cell lysis, pfH, protective proteins and organ injury, limits will be set for safe levels of pfH following the use of CPB. These results will be compared to existing laboratory-based methods for determining red blood cell damage to predict CPB assist device safety. Further, results from the studies described in this proposal will help develop therapeutic strategies to benefit patients by early detection of pfH and clearance protein levels that occur during CPB.