Autologous Blood Management for Postoperative Hemorrhage

Overseen By Angela R Neufeld, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Renal impairment, Anemia, Hemoglobinopathy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

64 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for managing blood loss during heart surgery. It aims to determine if using a patient’s own blood (autologous whole blood management) reduces bleeding and complications more effectively than the standard method of using donated blood. Participants will be randomly assigned to one of two groups: one will use their own blood, and the other will use donated blood products. The trial seeks adults at the Mazankowski Alberta Heart Institute undergoing heart surgery who are at high risk for blood clotting issues.

As an unphased trial, this study provides patients the opportunity to contribute to innovative research that could enhance surgical outcomes.

Will I have to stop taking my current medications?

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 prior data suggests that this protocol is safe for managing postoperative hemorrhage?

Research shows that using a patient's own blood during surgery is safe. In a study with 462 surgery patients, 79.5% donated their own blood for later use, greatly reducing the need for donor blood. Another study found that using a patient’s own blood lowered the risk of complications associated with receiving donor blood. Collecting and using a patient's own blood during surgery is both safe and effective in reducing blood loss. Overall, research supports that this practice is well-tolerated and can help avoid complications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using autologous whole blood management for postoperative hemorrhage because it involves a novel approach of using the patient’s own blood, reducing the need for donor blood products. This method involves withdrawing and then re-infusing the patient’s blood during heart surgery, which could decrease the risks associated with transfusions from other donors, such as allergic reactions or infections. Additionally, by using the patient's own blood, this technique may enhance recovery by potentially improving clotting and reducing immune response complications.

What evidence suggests that this protocol is effective for managing postoperative hemorrhage?

This trial will compare two approaches for managing blood during and after heart surgery. Participants in one arm will receive Autologous Whole Blood Management, using their own blood during surgery. Research has shown that using a patient's own blood can reduce bleeding and the need for donated blood. Specifically, one study found that only about 14% of patients who received their own blood after surgery required extra donor blood. Other studies indicate that this method lowers overall blood loss and reduces complications like excessive bleeding. Additionally, using a patient's own blood improves oxygen delivery to cells after surgery, aiding recovery. Participants in the other arm will receive standard care involving allogenic and/or derivative transfusion. ^{3 4 6 7 8}

Who Is on the Research Team?

Angela R Neufeld, MD

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

Adults over 18 years old who are having heart surgery at the Mazankowski Alberta Heart Institute and are at high risk for blood clotting problems can join. The trial is not open to those who don't meet these specific conditions.

Inclusion Criteria

I am at high risk for developing blood clotting problems.

I am a surgical patient at the Mazankowski Alberta Heart Institute.

Exclusion Criteria

I have a bacterial infection in my blood or heart.

I have severe narrowing in my carotid artery.

Preoperative anemia (hematocrit < 30%)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cardiac surgery with either autologous whole blood management or standard allogenic transfusion

1 week

In-hospital stay for surgery and immediate recovery

Follow-up

Participants are monitored for safety and effectiveness after treatment, including incidence of complications and length of hospital stay

30 days

Regular follow-up visits and monitoring

Long-term Follow-up

Participants are monitored for long-term outcomes such as incidence of myocardial infarction, stroke, and other complications

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Autologous Whole Blood Management
• Standard Care involving allogenic and/or derivative transfusion

Trial Overview The study compares two ways of managing blood loss during heart surgery: one group will use their own donated blood, while the other will receive standard care with transfusions from donors. The aim is to see if using one's own blood reduces bleeding, need for donor blood, and complications.

How Is the Trial Designed?

Group I: Autologous Whole Blood Management Experimental Treatment 1 Intervention

Intraoperative high volume autologous whole blood withdrawal prior to cardiopulmonary bypass (CPB) with re-transfusion following weaning from CPB.

Group II: Allogenic and Derivative Transfusion Active Control 1 Intervention

Control arm participants will receive standard care involving transfusion of plasma, platelets, cryoprecipitate, and/or lyophilized concentrates following weaning from CPB.

Autologous Whole Blood Management is already approved in Canada, United States, European Union for the following indications:

Approved in Canada as Autologous Whole Blood Management for:

• Reduction of blood loss in adult cardiac surgery patients

Approved in United States as Autologous Blood Transfusion for:

• Elective cardiac surgery
• Reduction of homologous blood needs

Approved in European Union as Autologous Blood Transfusion for:

• Cardiac surgery
• Reduction of blood loss and transfusion requirements

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

University Hospital Foundation

Collaborator

Trials

8

Recruited

1,800+

Alberta Innovates Health Solutions

Collaborator

Trials

54

Recruited

94,100+

EPICORE Centre

Collaborator

Trials

2

Recruited

170+

Published Research Related to This Trial

Autologous blood transfusion, which involves collecting and reinfusing a patient's own blood, can be performed in four different ways, offering a safer alternative to traditional blood transfusions by reducing complications associated with donor blood.

Despite its advantages, autotransfusion has inherent risks that have limited its widespread acceptance, particularly in the context of intraoperative blood salvage and retransfusion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autotransfusion; a review. Saarela, E.[2004]

The perception of improved safety in allogeneic blood transfusions is challenging the use of autologous blood donation methods, but these methods remain important in high-risk surgical settings where patients are likely to need transfusions.

Preoperative autologous blood donation and techniques like acute normovolaemic haemodilution can be effective in reducing the need for allogeneic transfusions, especially when combined with other measures like iron or erythropoietin administration to enhance patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modern concepts of autologous haemotherapy. Karger, R., Kretschmer, V.[2006]

Autologous blood transfusion can reduce risks associated with homologous transfusions, such as erythrocyte alloimmunization and transmission of viral or parasitic diseases, making it a potentially safer option for patients.

However, autologous transfusions also carry risks, including hemolysis, bacterial infections, and complications from whole blood donations, which can lead to cardiovascular issues and increased bleeding during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Benefits and risks of scheduled autologous transfusion]. Danic, B., Beauplet, A.[2019]

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 is considered safer than homologous transfusion due to a lower risk of transfusion reactions, but it still carries risks such as bacterial contamination and severe hemolytic reactions, particularly if there are errors in blood sample or unit exchanges.

Preoperative autologous blood donation should be offered to all patients undergoing elective surgery where significant blood loss is anticipated, and it is particularly indicated when at least 1.5 liters of blood loss is expected during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Preoperative donation of autologous blood and plasma]. Weippert, M., Kretschmer, V., Roewer, J.[2006]

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 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]

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]

Erythropoietin therapy significantly increases the percentage of patients able to donate at least 4 units of blood for autologous transfusion, with an odds ratio of 6.00 based on a meta-analysis of 18 studies involving 1914 patients.

Patients receiving erythropoietin experienced less reduction in hematocrit and hemoglobin levels before surgery compared to controls, indicating better preservation of blood parameters, although there was no significant difference in the amount of allogenic blood transfused between the two groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of preoperative erythropoietin therapy to facilitate autologous blood donation in orthopedic surgery: A meta-analysis. Chang, X., Li, Q., Tang, H.[2021]

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 462 patients undergoing surgery, 284 (79.5%) were able to donate their own blood for autologous transfusion, significantly reducing the need for allogenic blood transfusions.

The use of autologous blood donation was particularly beneficial in oncologic surgeries, with only 1.06% of patients requiring heterologous transfusions, highlighting its effectiveness in minimizing transfusion-related risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Preoperative autologous blood donation and transfusion in gynecology]. Foglia, G., Corticelli, A., Podestà, M., et al.[2006]

Transfusing washed postoperatively salvaged red blood cells (RBCs) using the OrthoPat device is more expensive than using unwashed shed blood for both total knee arthroplasty (TKA) and total hip arthroplasty (THA).

In THA, washed salvaged RBCs can lead to significant cost savings compared to allogeneic blood transfusions, while in TKA, the costs are comparable but depend on the number of units collected and infused.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A cost study of postoperative cell salvage in the setting of elective primary hip and knee arthroplasty. Rao, VK., Dyga, R., Bartels, C., et al.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/16038170/

[Effectiveness of postoperative autologous blood ... Results: A total of 107 patients were studied. Eighty-three received autologous blood transfusions after surgery and 15 (14.02%) required allogenic transfusion.

2. 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 ...

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

Comparison of the effects of autologous and non- ... We also conclude that it is more effective than non-autologous transfusion for reducing the possibility of bleeding while in the intensive care unit, reducing ...

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 ... BACKGROUND: Transfusing fresh autologous blood during cardiac surgery may improve hemostasis and decrease the need for transfusion.

5. journals.lww.com journals.lww.com/international-journal-of-surgery/fulltext/2023/10000/autologous_blood_transfusion_reduces_the.23.aspx

Autologous blood transfusion reduces the requirement for... Results: 32% of the lost blood volume was replaced through autologous transfusion in patients receiving cell salvage. Although the cell salvage group ...

6. withpower.com withpower.com/trial/phase-hemorrhage-6-2023-40403

Autologous Blood Management for Postoperative ... In a study of 462 patients undergoing surgery, 284 (79.5%) were able to donate their own blood for autologous transfusion, significantly reducing the need for ...

7. 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.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03204357

Fresh Autologous Whole Blood Transfusion After ... Collection of autologous blood before cardiopulmonary bypass (CPB) for transfusion after CPB has been shown to be both safe and effective for reducing blood ...