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Cardiopulmonary Bypass clinical trials

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NCT ID: NCT01173822 Completed - Surgery Clinical Trials

Processed Residual Pump Blood in Cardiac Surgery: The PRBC Trial

PRBC
Start date: December 2004
Phase: N/A
Study type: Interventional

The study is an randomized controlled trial (RCT) of 198 coronary artery bypass graft (CABG) patients, exploring whether ultrafiltration of residual blood in the cardiopulmonary bypass circuit reduces transfusion and bleeding.

NCT ID: NCT01144039 Completed - Myocardial Ischemia Clinical Trials

Glutamate and Diastolic Function in Patients Undergoing Aortic Valve Repair

Start date: February 2006
Phase: Phase 4
Study type: Interventional

Purpose: The effect of intravenous glutamate infusion on myocardial diastolic function and overall hemodynamics were studied in patients undergoing elective aortic valve replacement with severe aortic stenosis and associated left ventricular hypertrophy . Methods: 25 patients will be included in this double-blind randomized placebo-controlled study. Glutamate was administered intravenously immediately after aortic cross-clamp release. The patients receive either a low dose of 30mg kg-1 h-1 (LG-group) or high dose of 60 mg kg-1 h-1 (HG-group) or placebo (P-group) at a rate of 3.3ml kg-1h-1 for 2h. Transesophageal echocardiography (TEE) is used to measure diastolic and systolic ventricular function before sternotomy (T0), and 2h (T2), 3h (T3) and 6h (T4) after release of cross clamp. Additionally routine hemodynamic parameters are measured intraoperatively.

NCT ID: NCT01022736 Completed - Clinical trials for Cardiopulmonary Bypass

Plasma Gabapentin Concentration During and Following Cardiac Bypass

Start date: May 2007
Phase: Phase 4
Study type: Interventional

This open label investigation is to determine whether cardiopulmonary bypass affects plasma gabapentin concentration after preoperative administration in the setting of cardiac bypass surgery. Following signed informed consent, 16 patients scheduled for cardiac bypass surgery will be given gabapentin (600mg, oral) 1 hour prior to surgery, 1 hour following extubation and then every 8 hours for a total of 4 doses. Plasma gabapentin levels will be measured prior to induction, prior to bypass, 10 min into the bypass procedure, 10 minutes before separation from bypass, 30 minutes following bypass and then before and 2 hours following each of the next 3 doses of gabapentin. Pain scores, sedation scores, side effects and morphine equivalents will be documented for one day following surgery.

NCT ID: NCT00981474 Completed - Thoracic Surgery Clinical Trials

Cerebral Autoregulation Monitoring During Cardiac Surgery

Start date: September 1, 2009
Phase: N/A
Study type: Interventional

Neurological complications from cardiac surgery are an important source of operative mortality, prolonged hospitalization, health care expenditure, and impaired quality of life. New strategies of care are needed to avoid rising complications for the growing number of aged patients undergoing cardiac surgery. This study will evaluate novel methods for reducing brain injury during surgery from inadequate brain blood flow using techniques that could be widely employed.

NCT ID: NCT00860405 Completed - Cardiac Surgery Clinical Trials

Voluven® in Paediatric Patients

Start date: March 2009
Phase: Phase 4
Study type: Interventional

This study will compare the clinical efficacy and safety of Voluven® and Human Albumin during elective open-heart surgery in pediatric patients.

NCT ID: NCT00854048 Completed - Clinical trials for Cardiopulmonary Bypass

The Performance of Pulse Oximeters in Pediatric Patients With Low Oxygen Saturation Levels

Start date: December 2007
Phase: N/A
Study type: Observational

Evaluate pulse oximeters with children after cardiopulmonary by-pass under low Oxygen conditions.

NCT ID: NCT00809393 Completed - Hemorrhage Clinical Trials

Dose-ranging Study of Two Doses of Tranexamic Acid During Cardiac Surgery

Exacylcardio
Start date: February 2009
Phase: Phase 4
Study type: Interventional

Cardiac surgery with CardioPulmonary Bypass (CPB) exposes to per and postoperative bleeding, and may lead to allogenic blood transfusion re-intervention and many adverse outcomes. Prophylactic use of tranexamic Acid (TA) has been shown to decrease blood loss and blood transfusion during cardiac surgery.There currently are multiple dosing regimens for TA for cardiac surgery.Preliminary dose-response study has shown that low prophylactic dose of TA would be as accurate for haemostatic efficacy as higher dose. The primary objective of this tri-center, prospective, double-blinded, randomised trial is to compare two administrations and dosing regimens of TA during cardiac surgery with CPB on the perioperative blood loss. In addition to the clinical study, a pharmacokinétic/pharmacodynamic study will be conducted. Patients are divided in two groups: low and high risk surgery. Methods: After written informed consent, patients are randomly assigned to one of the two treatment groups. The low dose TA group is: 10 mg/kg TA given over 15 min, followed by an infusion of 1 mg/kg/h throughout the operation, and 1 mg/kg into the CPB prime volume. The high dose group is :30 mg/kg TA given over 15 min, followed by an infusion of 16 mg/kg/h throughout the operation, and 2 mg/kg into the CPB prime volume. Hemodynamic and anaesthesia care will be as usual. A blood salvage device will be systematically used. The triggers for transfusion will be: red blood cells: haemoglobin less than 8 g/dl or 6 g/dl during CBP; Plasma: PT less than 50% or INR more than 1.5; platelets: platelets count less than 50/70 G/mm3; fibrinogen: fibrinogen less than 1g/l . All patients will receive standard anaesthesia and perioperative care. In 60 consecutive patients in the principal investigator center, 5 blood samples will allow to assess the plasmatic concentration of tranexamic acid at different time of the surgery procedure: 1. Baseline 2. 5 min after the loading dose 3. 10 min after the beginning of bypass 4. at the discontinuation of the infusion 5. 1 hour after the discontinuation Plasmatic dosage will be assessed using a high performance liquid chromatography technique. Patients will be stratified in two groups for the statistical analysis; low and high risk surgery. Analysis will be in intention to treat. 300 patients should be recruited in each group to detect an absolute difference of respectively 10% (low risk cardiac surgery) and 20% (high risk cardiac surgery) in the number of patients exposed to allogenic blood transfusion between patients receiving high dose TA regimen and those receiving low dose TA regimen, assuming a power of 80% and a two-tailed value less than 0.05.

NCT ID: NCT00747331 Completed - Clinical trials for Cardiopulmonary Bypass

Fenoldopam and Splanchnic Perfusion During Cardiopulmonary Bypass

Start date: September 2008
Phase: Phase 4
Study type: Interventional

Cardiopulmonary bypass (CPB) for cardiac operations may be accompanied by different patterns of visceral underperfusion. This could result in clinical patterns of lactic acidosis but in the most severe cases there is the risk for mesenteric infarction (0.2% of the cases). Renal function as well may be impaired due to a low oxygen delivery, and acute renal failure occurs in 1-2% of cases. Fenoldopam mesilate is a selective splanchnic vasodilator when used at a dose < 0.1 mcg/kg/min. The experimental hypothesis of this randomized, controlled trial (RCT) is that the use of fenoldopam may determine a better visceral perfusion during CPB.

NCT ID: NCT00672516 Completed - Hemorrhage Clinical Trials

Management of Bleeding Following Cardiopulmonary Bypass

Start date: April 2008
Phase: N/A
Study type: Observational

We believe ongoing bleeding during complex cardiac surgery can be accurately measured and that administration of a specific blood product replacement strategy designed to optimally slow or stop the bleeding can be followed by the during the operation. Patients at risk of significant bleeding after complex cardiac surgery will be approached to allow their operation to be watched by study personnel to see if ongoing blood loss can be accurately measured and to see how quickly a prescribed, standardized blood product replacement protocol to control the bleeding does slow or stop the bleeding. Permission to review the medical record to see if bleeding risk features can be identified and permission to follow the patient after surgery to see how they recover is also requested.

NCT ID: NCT00653042 Completed - Clinical trials for Congestive Heart Failure

Clinical Study to Evaluate Nesiritide in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery A014 / NAPA

Start date: March 2004
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the effects of nesiritide compared to placebo when given with standard of care therapies, on kidney function, heart function and the need of other treatments in heart failure patients undergoing heart bypass graft surgery that requires the use of a cardiopulmonary bypass machine (CPB pump or heart-lung machine).