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Acute Normovolemic Hemodilution (ANH) in Patients Undergoing Cardiac Surgery

2019-10-21 12:45:31 | BioPortfolio

Summary

The purpose of this small randomized pilot study is to evaluate adherence to strict transfusion protocols in both the control and ANH group examining compliant and noncompliant transfusion rates and reasons for violation of the protocol if present. Data on transfusion requirements for both groups (with and without ANH) will be evaluated to determine sample size and feasibility of performing a larger study on ANH in our patient population. The ultimate purpose of a larger study would be to determine if acute normovolemic hemodilution results in a reduction in red blood cell units transfused in patients undergoing cardiac surgery involving cardiopulmonary bypass (CPB) and to carefully determine provider adherence to specific transfusion triggers for the administration of each unit of harvested and banked blood transfused. Secondary endpoints that will be evaluated in a larger study include any difference in the number of other blood products transfused including fresh frozen plasma, platelets, and cryoprecipitate as well as differences in coagulation status as measured by thromboelastography (TEG), INR/PTT, platelet count, and fibrinogen level, and ICU/hospital length of stay.

Description

Cardiac surgery patients are typically at higher risk of receiving blood transfusions during surgery than patients presenting for most other surgical procedures. Acute normovolemic hemodilution (ANH) is a method of blood conservation used to reduce the amount of donor blood transfused. It involves removing blood from appropriate patients immediately after the induction of anesthesia, replacing the volume lost with colloids (e.g. 5% albumin), then storing and returning this blood to the patient at the completion of the surgical procedures. By reducing the patient's hematocrit during surgery, the blood that is shed during the procedure has a lower red blood cell volume and therefore fewer red blood cells are lost during major blood loss. In addition, the autologous stored blood contains coagulation factors that are spared and returned following the procedure. This process is already performed here and at other institutions as a potential means of reducing transfusions in high risk patients. However, in spite of multiple publications, the actual value of this procedure is unclear, in part because many of the published studies in cardiac surgical patients failed to establish firm protocol- specific guidelines for either returning harvested blood to the patient or for using banked blood, or because it is unclear whether these guidelines were actually followed during surgery (rather than left to the discretion of anesthesiologists and surgeons).

The primary goal of this pilot study is to implement rigorous transfusion protocols for both ANH and routine transfusion practice and to examine compliant and noncompliant transfusion rates in both the ANH and control groups, evaluating reasons for violation of the transfusion protocol if applicable and to determine the feasibility of performing a larger study on ANH. Secondary goals for this pilot study include gathering data on transfusion rates in ANH versus control patients to determine the sample size for a larger, definitive study in which the primary goal would be to evaluate the effectiveness of ANH in reducing transfusion of banked blood units during cardiac surgery as compared to control patients in which ANH is not used. Secondary endpoints of a larger study would also include evaluating coagulation status in patients undergoing ANH versus control patients.

Study Design

Conditions

Surgery--Complications

Intervention

Acute Normovolemic Hemodilution (ANH)

Location

University of Minnesota Medical Center
Minneapolis
Minnesota
United States
55455

Status

Not yet recruiting

Source

University of Minnesota - Clinical and Translational Science Institute

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-21T12:45:31-0400

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PubMed Articles [15797 Associated PubMed Articles listed on BioPortfolio]

Platelet function, but not thrombin generation, is impaired in acute normovolemic hemodilution (ANH) blood.

We investigated the coagulation changes that might occur in acute normovolemic hemodilution (ANH) blood over several hours during cardiac surgery requiring cardiopulmonary bypass.

Acute normovolemic hemodilution and acute kidney injury after open abdominal cancer surgery.

The efficacy of acute normovolemic hemodilution for preventing perioperative allogeneic blood transfusion in gynecological cancer patients.

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Medical and Biotech [MESH] Definitions

Complications that affect patients during surgery. They may or may not be associated with the disease for which the surgery is done, or within the same surgical procedure.

Pathologic processes that affect patients after a surgical procedure. They may or may not be related to the disease for which the surgery was done, and they may or may not be direct results of the surgery.

Persistent detrimental effects from treatment for a condition. Included are effects from surgery such as POSTOPERATIVE COMPLICATIONS, and from DRUG THERAPY, such as CHEMICALLY INDUCED DISORDERS, or other THERAPEUTICS. Failure to attain a desired outcome from treatment for the condition is not considered an adverse effect.

Reduction of blood viscosity usually by the addition of cell free solutions. Used clinically (1) in states of impaired microcirculation, (2) for replacement of intraoperative blood loss without homologous blood transfusion, and (3) in cardiopulmonary bypass and hypothermia.

Surgical procedures conducted with the aid of computers. This is most frequently used in orthopedic and laparoscopic surgery for implant placement and instrument guidance. Image-guided surgery interactively combines prior CT scans or MRI images with real-time video.

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