What this study is
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.
What's being tested
- Fresh Autologous whole Blood
Intervention · OTHER
Subjects randomized this arm will receive fresh autologous whole blood
- Standard of Care Expectant management of bleeding
Intervention · OTHER
the control group that will receive the standard of care expectant management of bleeding and transfusion of allogenic banked blood products
Study details
- Official title
- Targeted Fresh Autologous Whole Blood Transfusion After Cardiopulmonary Bypass: a Prospective Randomized Controlled Trial.
- Sponsor
- University of Colorado, Denver
- Conditions
- Cardiac Disease · Bleeding Postoperative
- Enrolling
- 70 people
- Starts
- 2022-01-24
- Est. completion
- 2026-09
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 90 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Adult subjects aged 18 to 90
- Able to provide informed consent
- Willing to accept autologous or allogenic blood transfusion
- Scheduled for elective cardiac surgery with cardiopulmonary bypass
You can't join if
- Pre-operative administration of allogenic blood bank products in the previous 3 months
- 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
- Hemoglobin less than 7 g/dl
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (1)
1 openUniversity of Colorado Hospital
Aurora, Colorado, United States
- Nathan Clendenen, MD MS · Contact
- Nathan J Clendenen, MD MS · Principal investigator
Recruiting
Study team
Sponsor
University of Colorado, Denver
Study ID 16-2647
Principal investigator
Nathan Clendenen, M.D.
University of Colorado - School of Medicine
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.