Autologous Blood Transfusion for Postoperative Hemorrhage

Recruiting in Palo Alto (17 mi)

Overseen by Nathan Weitzel, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Colorado, Denver

Must not be taking: Intravenous vasopressors

Disqualifiers: Blood transfusion, Hemodynamic instability, Infection, others

No Placebo Group

Approved in 3 Jurisdictions

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.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Fresh Autologous Whole Blood Transfusion for Postoperative Hemorrhage?

Research shows that using a patient's own blood (autologous blood transfusion) during surgeries like hip replacement and cardiac surgery can reduce the need for donor blood and improve blood clotting, which may help manage bleeding after surgery.

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Is autologous blood transfusion generally safe for humans?

Autologous blood transfusion, where a person receives their own blood, is considered the safest type of blood transfusion when guidelines are followed. It reduces the risk of infections and immune reactions compared to donor blood, although some minor adverse reactions can still occur.

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How is the treatment of Fresh Autologous Whole Blood Transfusion unique for postoperative hemorrhage?

Fresh Autologous Whole Blood Transfusion is unique because it uses the patient's own blood, collected and reinfused during or after surgery, reducing the risk of infections and complications associated with donor blood. This method is considered the safest form of transfusion and can be used in various surgical settings to minimize the need for donor blood.

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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.

I am between 18 and 90 years old.

You are willing to receive a blood transfusion using your own blood or someone else's blood.

Exclusion Criteria

Your hemoglobin level is less than 7 grams per deciliter.

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.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative

Collection of autologous blood before cardiopulmonary bypass for transfusion after CPB

1 day

1 visit (in-person)

Treatment

Transfusion of fresh autologous whole blood versus standard of care expectant management of bleeding during elective cardiac surgery

1 day

1 visit (in-person)

Post-operative Monitoring

Monitoring for complications such as myocardial infarction, heart failure, and other secondary outcomes

31 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Participant Groups

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.

Group I: Fresh Autologous whole blood transfusion Experimental Treatment 1 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 bleeding Active Control 1 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 Nearby Select from list below to view details:

University of Colorado Hospital Aurora, CO

Who Is Running the Clinical Trial?

University of Colorado, Denver Lead Sponsor

References

1. England pubmed.ncbi.nlm.nih.gov

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.

2. United States pubmed.ncbi.nlm.nih.gov

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.

3. Serbia pubmed.ncbi.nlm.nih.gov

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.

4. England pubmed.ncbi.nlm.nih.gov

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.

5. Malaysia pubmed.ncbi.nlm.nih.gov

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.

6. England pubmed.ncbi.nlm.nih.gov

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.

7. United States pubmed.ncbi.nlm.nih.gov

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.

8. Switzerland pubmed.ncbi.nlm.nih.gov

[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.

9. Serbia pubmed.ncbi.nlm.nih.gov

[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.

10. United States pubmed.ncbi.nlm.nih.gov

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.

11. England pubmed.ncbi.nlm.nih.gov

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.