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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether using a person's own blood for a transfusion, known as Fresh Autologous Whole Blood Transfusion, after heart surgery can reduce bleeding and improve oxygen delivery to cells. Researchers will compare this method to the usual care, which manages bleeding with donated blood. The trial targets individuals undergoing elective heart surgery involving cardiopulmonary bypass, where a machine temporarily takes over heart and lung function. Ideal candidates are those scheduled for such surgery and willing to receive either their own or donated blood post-operation. As an unphased trial, this study offers patients the chance to contribute to innovative research that could enhance heart surgery outcomes.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that using a patient's own fresh blood for transfusions can be safe and effective. Earlier studies found that taking a person's blood before surgery and returning it afterward reduced the need for other blood products. This approach lowers the risks of infections or reactions associated with donor blood.

Using one's own blood for transfusions has decreased the need for additional blood transfusions and even lowered the risk of death in some surgeries. It also helps maintain better blood levels after surgery. This is important because using one's own blood typically results in fewer side effects compared to donor blood. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using fresh autologous whole blood transfusion for postoperative hemorrhage because it offers a personalized approach to managing blood loss. Unlike the standard treatment, which involves transfusing banked allogenic blood, this method uses the patient’s own blood collected during surgery, reducing the risk of transfusion-related complications like immune reactions. Additionally, it ensures the blood is fresh, potentially enhancing its effectiveness in stabilizing the patient more quickly.

What evidence suggests that autologous blood transfusion is effective for reducing postoperative hemorrhage?

Research has shown that using a patient's own blood at the end of heart-lung machine surgery can reduce blood loss within 24 hours. In this trial, some participants will receive a fresh autologous whole blood transfusion, which helps deliver oxygen to cells, crucial for energy. Studies have found that using a patient's own blood can reduce the need for banked blood and may lower the risk of complications. Evidence also suggests it can lessen bleeding after surgery. Overall, using fresh blood from the patient appears promising for managing blood loss post-surgery. Meanwhile, other participants will receive standard care, which involves expectant management of bleeding with transfusions of allogenic banked blood products. ^{1 2 5 6 7}

Who Is on the Research Team?

Nathan Clendenen, MD MS

Principal Investigator

University of Colorado - School of Medicine

Are You a Good Fit for This Trial?

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.

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

Able to provide informed consent

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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 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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03204357

Fresh Autologous Whole Blood Transfusion After ... Autologous blood transfused at the end of cardiopulmonary bypass will reduce total blood loss 24 hours after surgery and improve mitochondrial oxygen delivery ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2405844023045796

Comparison of the effects of autologous and non- ... This study aimed to compare hematocrit (Htc) values and postoperative tube drainage, homologous blood transfusion requirements, extubation times in the ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10583901/

Autologous blood transfusion reduces the requirement for ... Cell salvage use was associated with a reduction in allogenic blood transfusion and a reduction in 30-day mortality in patients undergoing major hepatectomy.

4. pure.johnshopkins.edu pure.johnshopkins.edu/en/publications/efficacy-of-autologous-fresh-whole-blood-or-plateletrich-plasma-i

Efficacy of autologous fresh whole blood or platelet‐rich ... CONCLUSION: Although a hemostatic benefit manifested as reduced postoperative bleeding was observed, this study does not support the use of fresh blood ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/7631401/

Efficacy of autologous fresh whole blood or platelet-rich ... Conclusion: Although a hemostatic benefit manifested as reduced postoperative bleeding was observed, this study does not support the use of fresh blood ...

6. withpower.com withpower.com/trial/phase-postoperative-hemorrhage-8-2021-2bd86

Autologous Blood Transfusion for Postoperative Hemorrhage Autologous blood transfused at the end of cardiopulmonary bypass will reduce total blood loss 24 hours after surgery and improve mitochondrial oxygen ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4988483/

A review of the application of autologous blood transfusion Its application in surgeries with a small amount of bleeding in healthy adults can moderately improve early postoperative Hb levels and tissue ...