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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 belowSelect...
I am scheduled for heart surgery that will use a heart-lung machine.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 31 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~31 days
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 moreTrial 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
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Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,738 Previous Clinical Trials
2,149,456 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for heart surgery that will use a heart-lung machine.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.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.I have not received blood products from a donor in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Fresh Autologous whole blood transfusion
- Group 2: Standard of Care Expectant Management of bleeding
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this clinical study permit the participation of individuals who are over four decades in age?
"This clinical experiment has a minimum age requirement of 18 and is capped at 90, according to the admission criteria."
Answered by AI
Are any vacancies being offered to prospective research participants in this trial?
"As per clinicaltrials.gov, this research is currently accepting participants. It was published on January 24th 2022 and underwent a modification on the 28th of that same month."
Answered by AI
What is the participant quota for this research trial?
"Affirmative, the clinical trial is currently open for enrolment. The research was initially published on January 24th 2022 and last modified four days later. 70 participants are sought from a single site."
Answered by AI
Who is eligible to take part in this clinical research?
"This clinical trial is looking to recruit 70 individuals aged 18-90 with postoperative hemorrhages. Specifically, they should be adults who are able and willing to provide informed consent; acceptable of autologous or allogenic transfusions; and scheduled for elective cardiac surgery involving cardiopulmonary bypass."
Answered by AI
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