Trial Summary
What is the purpose of this trial?Autologous blood transfused at the end of cardiopulmonary bypass will reduce total blood loss 24 hours after surgery and improve mitochondrial oxygen delivery measured by plasma succinate levels.
The study design is a prospective randomized interventional trial of transfusion of fresh autologous whole blood versus standard of care expectant management of bleeding during elective cardiac surgery.
Is Fresh Autologous Whole Blood a promising treatment for postoperative bleeding?Yes, Fresh Autologous Whole Blood is a promising treatment for postoperative bleeding. It uses the patient's own blood, which is considered the safest form of transfusion. This method reduces the risk of infections and other complications that can occur with donor blood. It also helps manage blood needs during and after surgery without relying on donor blood.1691011
What safety data exists for autologous blood transfusion?Autologous blood transfusion is considered the safest type of blood transfusion when guidelines are followed, as it eliminates the risk of infection and alloimmunization associated with allogeneic transfusions. Studies have shown that while adverse reactions can occur, they are generally less frequent compared to allogeneic transfusions. The method reduces the need for donor blood and is endorsed by the Council on Scientific Affairs. However, it does not completely eliminate all risks, such as hemolytic, febrile, and allergic reactions.357810
Do I need to stop my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications.
What data supports the idea that Autologous Blood Transfusion for Postoperative Hemorrhage is an effective treatment?The available research shows that autologous blood transfusion can reduce the need for donor blood during surgeries, such as hip replacement and cardiac surgery. This means patients can use their own blood, which is safer and helps avoid complications from using someone else's blood. Studies have shown that this method can improve blood clotting and reduce the need for additional blood transfusions, making it an effective treatment for managing blood loss after surgery.2481011
Eligibility Criteria
This trial is for adults aged 18 to 90 who can consent, are open to blood transfusions, and are scheduled for elective heart surgery with cardiopulmonary bypass. It's not for those who've had a recent blood transfusion, are unstable with low blood pressure or high heart rate, have an active infection or sepsis, or very low hemoglobin.Inclusion Criteria
I am scheduled for heart surgery that will use a heart-lung machine.
Exclusion Criteria
My blood pressure is low and my heart rate is high, or I need medicine to maintain my blood pressure.
I do not have a serious infection or sepsis.
Treatment Details
The trial tests if giving patients their own fresh whole blood after heart surgery reduces total blood loss within the first day post-surgery and improves oxygen delivery at the cellular level compared to standard bleeding management practices.
2Treatment groups
Experimental Treatment
Active Control
Group I: Fresh Autologous whole blood transfusionExperimental Treatment1 Intervention
The experimental group will have 15% of the estimated blood volume of autologous blood collected. This transfusion will be given at the end of the procedure.
Group II: Standard of Care Expectant Management of bleedingActive Control1 Intervention
the control group that will receive the standard of care expectant management of bleeding and transfusion of allogenic banked blood products
Fresh Autologous whole Blood is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Autologous Blood Transfusion for:
- Cardiac surgery
- Elective surgeries with high risk of bleeding
🇪🇺 Approved in European Union as Autologous Blood Transfusion for:
- Cardiac surgery
- Elective surgeries with high risk of bleeding
- Rare blood types or specific blood matching needs
🇨🇦 Approved in Canada as Autologous Blood Transfusion for:
- Cardiac surgery
- Elective surgeries with high risk of bleeding
- Patients with specific blood matching needs
Find a clinic near you
Research locations nearbySelect from list below to view details:
University of Colorado HospitalAurora, CO
Loading ...
Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
References
Autologous blood transfusion. [2013]Autologous blood transfusion is a procedure in which blood is removed from a donor and returned to his circulation at some later time. Autologous transfusion can be performed in three ways: (1) preoperative blood collection, storage, and retransfusion during surgery; (2) immediate preoperative phlebotomy with subsequent artificial hemodilution and later return of the phlebotomized blood; and (3) intraoperative blood salvage and retransfusion. All three methods of autologous transfusion offer a potentially superior method of blood transfusion which eliminates many of the problems and complications associated with the banking and administration of homologous donor blood.
Autologous blood transfusion. [2017]Autologous blood transfusion--transfusion to the patient of his or her own blood--is of increasing importance in transfusion practice. There are three main techniques: pre-deposit, in which patients donate blood over a period of time in preparation for elective surgery; preoperative isovolaemic haemodilution, in which blood is removed in theatre immediately preoperatively and volume replacement is given, the blood being reinfused postoperatively; and salvage transfusion - the harvesting of blood shed at surgery or in similar circumstances, which is reinfused immediately or after concentration and purification. All these techniques can play a part in rendering transfusion safer and in economising on scarce supplies of donor blood.
Autologous blood transfusions. Council on Scientific Affairs. [2022]Blood collected from a patient for retransfusion at a later time into that same individual is called "autologous blood." When the guidelines established by the American Association of Blood Banks are followed, autologous blood is the safest type of blood for transfusion. It also decreases the demand for banked blood and eliminates the risk of infection and alloimmunization from a transfusion. Autologous transfusions are becoming widely available; since 1974 the number of institutions providing autologous transfusion programs has increased more than fourfold. The Council on Scientific Affairs endorses the use of autologous blood transfusions.
Efficacy of autologous fresh whole blood or platelet-rich plasma in adult cardiac surgery. [2019]Transfusing fresh autologous blood during cardiac surgery may improve hemostasis and decrease the need for transfusion.
A survey of autologous blood collection and transfusion in Japan in 1997. [2019]In spite of the fact that autologous blood is safest for a patient to receive, it is not generally appreciated that adverse reactions during donation and transfusion may occur. This study was conducted to assess the state and the risk of autologous blood transfusion in Japan in 1997.
[Autologous transfusion and its use in clinical practice]. [2009]Autologous transfusion is the reinfusion of a patient's own blood. Increased awareness of the risks of homologous transfusion, primarily transfusion transmitted infections has caused patients and physicians to search for safer alternatives. One promising alternative is autologous transfusion, generally accepted as the safest form of transfusion. Current strategies of autologous transfusion include preoperative collection of autologous blood, intraoperative salvage of autologous blood, postoperative salvage of autologous blood and acute normovolemic haemodilution. Preoperative collection is performed to ensure the patient's blood for elective surgical procedures. Intraoperative salvage consists of aspirating blood from surgical fields or other sterile bleeding sites, and returning this blood to the patient. Postoperative blood salvage is retrieval of blood shed within the first 24-48 hours postoperatively in patients who are actively bleeding, usually after cardiopulmonary bypass procedures. Acute normovolemic haemodilution is the rapid removal of blood and simultaneous replacement with cell-free fluid. It appears likely that combination of various autologous transfusion strategies is necessary for the successeful functioning of autologous transfusion programme.
[Transfusion of autologous blood]. [2018]Recently the use of allogeneic (donor) blood transfusion is widely accepted in the clinical practice. Despite of good quality and safety of preparation of allogeneic blood, there are some risks related with transfusion: hemolytic, febrile, and allergic reactions, transfusion related acute lung injury, negative immunomodulatory effect, transmission of infections diseases, dissemination and recurrence of cancer. This is why the indications for donor blood transfusion are restricted, so new safer methods are discovered to avoid or to decrease the heed for allogeneic blood transfusion. Nowadays, there is an increased interest in autologous blood transfusion as the most acceptable alternative to allogeneic blood transfusion. Autologous transfusion is the collection and reinfusion of the patient's own blood (donor and recipient is the same person). Several types of autologous transfusion can be used: preoperative autologous blood donation, acute normovolemic hemodilution, intraoperative blood salvage, postoperative blood salvage. Neverless, autologous transfusion does not protect from all risks, it still remains the safest type of blood transfusion and is important in the strategy of blood conservation.
Transfusion of intra-operative autologous whole blood: influence on complement activation and interleukin formation. [2011]Transfusion of autologous whole blood is one available method to reduce the need for allogenic blood transfusion. The objective of this study was to investigate the safety of transfusion of intra-operative autologous whole blood by monitoring plasma concentration of laboratory variables and adverse events after transfusion with the Sangvia(®) system.
Blood-saving techniques. [2011]Major surgery is associated with intraoperative and postoperative bleeding, generally treated with homologous blood transfusions, which carry the risk of infection, allergic reactions, or incompatibility as well as a number of organizational and economic problems. Transfusion strategies and steps to minimize perioperative bleeding are needed. Another resource is drugs; human recombinant erythropoietin, aprotinin, and some analogues of lysine have been used to reduce the rate of allogenic transfusions in the perioperative period. The safest method is autologous blood transfusions through predeposits and hemodilution; however, it can only be used for elective surgery. Autologous transfusion techniques include blood collection, both intraoperatively, as described by Orr, and postoperatively, as introduced by Borghi in 1984, which enables the continuous monitoring of postoperative bleeding. Blood collection can also be performed during emergency surgery, reducing the rate and costs of homologous transfusions.
Quality of intraoperatively salvaged unwashed blood in hip arthroplasty. [2013]Transfusion of autologous whole blood is one available method to reduce the need for allogenic blood transfusion. The aim of the present study was to investigate the quality of shed blood collected in a new intraoperative autotransfusion system.
Autologous blood transfusion in patients undergoing hip replacement surgery. [2014]Autologous blood transfusion is a set of procedures done in order to collect a patient's blood and reinfuse it during or after a surgical intervention. The aim is to meet the patient's need for blood products without allogeneic transfusion. By observing the hemoglobin and hematocrit values during blood donation in the pre-operative and post-operative period and by counting transfused blood units, the aim of this article was to detect whether there was any difference between the patients receiving autologous blood and those receiving only allogeneic blood.