Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Hemorrhage

Liver Neoplasms

Hematinics

All Drugs and Chemicals

Liver Extracts

Robert CG Martin, MD

The purpose of this study is to demonstrate the safety and benefit of auto-transfusion filtered blood in patients undergoing major surgical oncology procedures.

Homologous blood transfusions during surgical procedures are becoming more challenging, due to lack of adequate reserves and the significant risks of transfusion reactions. Recent advances in the use of patient's own blood (autologous transfusion) has rapidly gained acceptance in major surgical procedures, however due to the requirement for prior planning and the expense of obtaining and storing a patient's blood prior to surgery this alternative is less than ideal.

This research study utilizes a third alternative, a technique called intraoperative autotransfusion, which successfully salvages a patient's blood during surgery and reinfuses the blood back into the patient. The blood salvaging device uses a filtration device that successfully filters out all tumor cells to prevent re-infusion of viable cancer cells.

This study is designed to demonstrate the safety and benefits of the blood salvaging device on patients undergoing major surgical oncology procedures.

Intraoperative Cell Saver Autotransfusion Use for Major Surgical Oncology Operations.

Phase I/II Evaluation of Intraoperative Autotransfusion Filtration for Major Surgical Oncology Operations

University of Louisville

Heart and Blood Diseases

Coronary Artery Disease

Syndrome

Necrosis

Myocardial Ischemia

Arteriosclerosis

Systemic Inflammatory Response Syndrome

Coronary Disease

Ischemia

Arterial Occlusive Diseases

Vascular Diseases

Inflammation

Shock

Heart Diseases

Cell saver intraoperatively for coronary artery bypass grafting using cardiopulmonary bypass

Cell saver

Conventional suction for coronary artery bypass grafting using cardiopulmonary bypass

No cell saver

Sune Damgaard, MD

Daniel A Steinbrüchel, Professor

Cardiac surgery using heart and lung machine produces an inflammatory reaction in the body. This leads in few percent of cases to heart, lung, and kidney disturbances that potentially causes death. White blood cells in contact with the heart and lung machine and external surfaces release mediators partly responsible for this. Blood collected by the suction and the blood remaining in the heart and lung machine after its use, can be cleaned by a cell saver before reinfusion, and this might reduce the inflammatory response.

Introduction

Cardiopulmonary bypass (CPB) during cardiac surgery induces in all patients a systemic inflammatory response syndrome (SIRS) that is more pronounced than for other surgical procedures. Depending on the severity of this, myocardial dysfunction, respiratory failure, renal and neurological dysfunction, coagulation disturbances and impaired liver function might follow. In worst cases this leads to acute respiratory distress syndrome, disseminated intravascular coagulation, multi organ failure, shock and death. The cause is besides the surgical trauma, the passage of the blood through the extra corporal circulation (ECC) and its pumps and oxygenator, hemodilution, hypothermia, heparin and protamine administration, ischemia and reperfusion, and endotoxemia (LPS) as a cause of intestinal ischemia. The ECC is the main cause of immunological activation and leads in severe cases to the so-called post-perfusion syndrome. This is characterised by increased capillary permeability and intercellular fluid, peripheral vasoconstriction, fever, myocardial edema, diffuse cerebral edema and diffuse hemorrhagic diathesis. This syndrome is considered to be a more severe form of SIRS. Even though most patients have no sequelae after CPB, all patients must be considered to be influenced, in varying degree, by SIRS. High levels of pro-inflammatory cytokines (interleukin (IL)-6, IL-8, IL-1a, IL-1b, tumor necrosis factor (TNF) alfa), have generally been associated with adverse events after CPB. Of importance is also LPS from gram-negative intestinal bacteria, translocating to the systemic circulation during ischemia.

Hypothesis

Cleansing of suction blood and the remaining blood in the ECC after termination of CPB, reduces the load of inflammatory cells and mediators in the patients' circulation. This potentially diminishes SIRS with a reduction in postoperative organ dysfunction and morbidity.

Aim

To cleanse suction blood and the remaining blood in the ECC after termination of CPB by means of a cell saver and monitor the influence on inflammatory mediators and the potential clinical benefits.

Outcome measures

Primary: Concentrations of IL-1B, IL-6, IL-8, IL-10, IL-12p70, TNFa, TNF-R1, TNF-R2, PCT and LPS in patient blood: 6, 24 and 72 hours after termination of CPB.

Secondary: Bleeding, need for allogenic blood transfusions and blood products and clinical effect focusing on known complications to cardiac surgery and CPB.

Design

Prospective randomised clinical trial including 40 patients planned for on-pump coronary artery bypass grafting (CABG). n=20 in the trial group (use of cell saver) and n=20 in the control group (no cell saver). No patients receive postoperative autotransfusion of drain blood.

Sample size

Estimation based on comparable studies.

Anaesthesia and surgery

In accordance with current guidelines of the clinic, this includes prophylactic antibiotics (cefuroxime and gentamycin). Cell saver: Medtronic Autolog.

Patient exclusion during the trial

Patients are excluded in cases of autotransfusion of blood not cleansed by the cell saver, for instance in cases of major blood loss.

Cleansing of Suction Blood in Cardiac Surgery for Reduced Inflammatory Response

Does Cleansing of Suction Blood During Cardiac Surgery With Heart and Lung Machine Reduce the Postoperative Inflammatory Response ?

Danish Heart Foundation

Copenhagen Hospital Corporation

Rigshospitalet, Denmark

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Intraoperative Cell Saver Autotransfusion Use for Major Surgical Oncology Operations.	NCT00708513	Pancreaticoduod... Pancreatectomy Esophagectomy Gastrectomy Hepatectomy		18 Years -	University of Louisville
Intraoperative Cell Saver Autotransfusion Use for Major Surgical Oncology Operations.	NCT00708513	Pancreaticoduod... Pancreatectomy Esophagectomy Gastrectomy Hepatectomy		18 Years -	University of Louisville
Cleansing of Suction Blood in Cardiac Surgery for Reduced Inflammatory Response	NCT00159926	Systemic Inflam... Coronary Arteri...	Cell saver No cell saver	18 Years -	Rigshospitalet, Denmark
Cleansing of Suction Blood in Cardiac Surgery for Reduced Inflammatory Response	NCT00159926	Systemic Inflam... Coronary Arteri...	Cell saver No cell saver	18 Years -	Rigshospitalet, Denmark

Spots Global Cancer Trial Database for cell saver

Every month we try and update this database with for cell saver cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cell saver

Every month we try and update this database with for cell saver cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cell saver cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.