Autologous Blood Transfusion for Postoperative Hemorrhage

Recruiting in Palo Alto (17 mi)

Overseen by Nathan Clendenen, MD MS

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. ^{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. ^{1 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 3 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.

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

Treatment Details

Interventions

• Fresh Autologous whole Blood (Procedure)
• Standard of Care Expectant management of bleeding (Behavioural Intervention)

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 Canada for the following indications:

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

Trials

1842

Patients Recruited

3,028,000+

Findings from Research

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]

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]

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]

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous blood transfusion. Slater, NG.[2017]

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

References

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

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

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

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

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

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

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

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

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

Autologous blood transfusion. [2017]

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. Serbia pubmed.ncbi.nlm.nih.gov

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

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

Blood-saving techniques. [2011]

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

Autologous blood transfusion. [2013]