Autologous Blood Transfusion for Postoperative Hemorrhage

Overseen By Nathan J Clendenen, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Must not be taking: Intravenous vasopressors

Disqualifiers: Blood transfusion, Hemodynamic instability, Infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

70 Participants Needed

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. ^{1 2 3 4 5}

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. ^{2 4 6 7 8}

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. ^{1 4 9 10 11}

Research Team

Nathan Clendenen, MD MS

Principal Investigator

University of Colorado - School of Medicine

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.

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

Treatment Details

Interventions

• Fresh Autologous whole Blood
• Standard of Care Expectant management of bleeding

Trial Overview 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.

Participant Groups

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

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Findings from Research

In a study of 60 patients, those who received autologous blood transfusions required fewer units of blood post-surgery (2.53 units) compared to those who received only allogeneic blood (3.73 units), indicating that autologous transfusion may be more efficient in managing blood needs during recovery.

The use of oral iron supplements before the first blood donation significantly increased hemoglobin levels, suggesting that pre-operative iron supplementation can enhance the effectiveness of autologous blood transfusion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous blood transfusion in patients undergoing hip replacement surgery. Tesić, I., Sekulić, J., Arbutinov, V., et al.[2014]

The study involving 20 patients undergoing hip arthroplasty found that transfusing autologous whole blood using the Sangvia® system resulted in only transient increases in inflammatory markers and plasma hemoglobin, which normalized shortly after the procedure.

No significant adverse events were reported, indicating that the use of the Sangvia® system for intra-operative blood collection and retransfusion is safe for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transfusion of intra-operative autologous whole blood: influence on complement activation and interleukin formation. Stachura, A., Król, R., Poplawski, T., et al.[2011]

Autologous blood transfusion, where patients receive their own blood, is becoming increasingly important in transfusion practices, enhancing safety and reducing reliance on donor blood.

There are three main techniques for autologous transfusion: pre-deposit, preoperative isovolaemic haemodilution, and salvage transfusion, all of which help make transfusions safer and more efficient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous blood transfusion. Slater, NG.[2017]

In a study involving 15 patients undergoing total hip arthroplasty, the Sangvia® autotransfusion system effectively collected shed blood, with an average blood loss of 364ml and a transfused volume of 200ml, indicating its practical use during surgery.

The quality of the salvaged blood, with a mean hemoglobin concentration of 62g/l, was comparable to previously reported studies on unwashed blood transfusions, suggesting that using this system is safe for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of intraoperatively salvaged unwashed blood in hip arthroplasty. Eshuis, R., Borgdorff, PJ., Kortlandt, W., et al.[2013]

In a study of 70 adult cardiac surgery patients, using fresh autologous blood components (either from intraoperative hemodilution or platelet-rich plasma) showed a reduction in postoperative bleeding compared to controls, indicating a potential hemostatic benefit.

However, there was no significant difference in the need for red cell transfusions, hemoglobin levels at discharge, or length of hospitalization among the groups, suggesting that these techniques may not be beneficial in low-risk cardiac surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of autologous fresh whole blood or platelet-rich plasma in adult cardiac surgery. Triulzi, DJ., Gilmor, GD., Ness, PM., et al.[2019]

In a study of autologous blood transfusions in Japan involving 14,200 patients, adverse reactions occurred in 1.6% of blood donations, highlighting that while autologous blood is generally safe, risks still exist during donation and transfusion processes.

The study found that 0.5% of transfused units experienced errors, such as clotting and bag breakage, indicating that systematic safety policies are needed to improve the safety of autologous blood transfusion programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A survey of autologous blood collection and transfusion in Japan in 1997. Ohto, H., Fuji, T., Wakimoto, N., et al.[2019]

Autologous blood transfusions, where patients receive their own previously collected blood, are considered the safest type of transfusion according to guidelines from the American Association of Blood Banks.

The use of autologous blood reduces the need for banked blood and eliminates risks associated with infections and alloimmunization, leading to a significant increase in institutions offering these programs since 1974.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous blood transfusions. Council on Scientific Affairs. [2022]

Allogeneic blood transfusions, while generally safe, carry risks such as hemolytic reactions, infections, and negative immunomodulatory effects, leading to restricted indications for their use.

Autologous blood transfusion, where patients receive their own blood, is considered the safest alternative and includes methods like preoperative donation and intraoperative salvage, helping to reduce the need for allogeneic transfusions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Transfusion of autologous blood]. Veikutiene, A., Sirvinskas, E., Adukauskiene, D.[2018]

Major surgery often leads to bleeding that is typically managed with blood transfusions, which can pose risks such as infections and allergic reactions, highlighting the need for better transfusion strategies and bleeding management.

Autologous blood transfusions, where patients use their own blood, are the safest option and can be implemented in elective surgeries, while techniques for collecting blood during emergency surgeries can also help reduce reliance on donor blood transfusions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood-saving techniques. Borghi, B., Borghi, R.[2011]

Autologous blood transfusion is a safe alternative to traditional blood transfusions, as it involves using a patient's own blood, which reduces the risk of complications associated with donor blood.

There are three methods of autologous transfusion: preoperative collection, immediate preoperative phlebotomy, and intraoperative blood salvage, all of which help minimize issues related to blood banking and compatibility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous blood transfusion. Brzica, SM., Pineda, AA., Taswell, HF.[2013]

Autologous transfusion, which involves reinfusing a patient's own blood, is considered the safest transfusion method, reducing the risk of transfusion-transmitted infections associated with homologous transfusions.

Different strategies for autologous transfusion, including preoperative collection, intraoperative salvage, postoperative salvage, and acute normovolemic haemodilution, may need to be combined for optimal effectiveness in surgical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Autologous transfusion and its use in clinical practice]. Radović, M., Manojlović, D.[2009]

References

1. Serbia pubmed.ncbi.nlm.nih.gov

Autologous blood transfusion in patients undergoing hip replacement surgery. [2014]

2. England pubmed.ncbi.nlm.nih.gov

Transfusion of intra-operative autologous whole blood: influence on complement activation and interleukin formation. [2011]

3. Malaysia pubmed.ncbi.nlm.nih.gov

Autologous blood transfusion. [2017]

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

Quality of intraoperatively salvaged unwashed blood in hip arthroplasty. [2013]

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

Efficacy of autologous fresh whole blood or platelet-rich plasma in adult cardiac surgery. [2019]

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

A survey of autologous blood collection and transfusion in Japan in 1997. [2019]

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

Autologous blood transfusions. Council on Scientific Affairs. [2022]

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

[Transfusion of autologous blood]. [2018]

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

Blood-saving techniques. [2011]

10. England pubmed.ncbi.nlm.nih.gov

Autologous blood transfusion. [2013]

11. Serbia pubmed.ncbi.nlm.nih.gov

[Autologous transfusion and its use in clinical practice]. [2009]