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Autologous Blood Transfusion for Postoperative Hemorrhage

N/A

Recruiting

Led By Nathan Weitzel, M.D.

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Scheduled for elective cardiac surgery with cardiopulmonary bypass

Be older than 18 years old

Must not have

Hemodynamically unstable defined as a systolic blood pressure less than 90 mmHg with a heart rate greater 100 or requiring intravenous vasopressor medications

Significant active infection or sepsis defined by positive blood culture or positive wound culture

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 31 days

Awards & highlights

No Placebo-Only Group

Summary

This trial found that transfusion of autologous blood at the end of cardiopulmonary bypass reduces total blood loss 24 hours after surgery and improves mitochondrial oxygen delivery, as measured by plasma succinate levels.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed here, autologous blood transfusions may include risks such as fever, allergic reactions, lung injury from fluid overload (TACO), and in rare cases immune system suppression.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for heart surgery that will use a heart-lung machine.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My blood pressure is low and my heart rate is high, or I need medicine to maintain my blood pressure.

Select...

I do not have a serious infection or sepsis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 31 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~31 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 31 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Estimated Blood Loss

Secondary study objectives

Change in endothelial function measured by flow mediated dilation of the brachial artery

Detection of New Onset Atrial fibrillation

Development of Acute Kidney Injury

+12 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Fresh Autologous whole blood transfusionExperimental Treatment1 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 bleedingActive Control1 Intervention

the control group that will receive the standard of care expectant management of bleeding and transfusion of allogenic banked blood products

0 / 3Eligibility criteria met