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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 31 days
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am scheduled for heart surgery that will use a heart-lung machine.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Estimated Blood Loss
Secondary outcome measures
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

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

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,749 Previous Clinical Trials
2,163,990 Total Patients Enrolled
Nathan Weitzel, M.D.Principal InvestigatorUniversity of Colorado - School of Medicine
Nathan Clendenen, M.D.Principal InvestigatorUniversity of Colorado - School of Medicine

Media Library

Fresh Autologous whole Blood Clinical Trial Eligibility Overview. Trial Name: NCT03204357 — N/A
Cardiovascular Disease Research Study Groups: Fresh Autologous whole blood transfusion, Standard of Care Expectant Management of bleeding
Cardiovascular Disease Clinical Trial 2023: Fresh Autologous whole Blood Highlights & Side Effects. Trial Name: NCT03204357 — N/A
Fresh Autologous whole Blood 2023 Treatment Timeline for Medical Study. Trial Name: NCT03204357 — N/A
~23 spots leftby Aug 2025
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