Autologous Blood Transfusion for Postoperative Hemorrhage
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?
Is autologous blood transfusion generally safe for humans?
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.1391011
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
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Pre-operative
Collection of autologous blood before cardiopulmonary bypass for transfusion after CPB
Treatment
Transfusion of fresh autologous whole blood versus standard of care expectant management of bleeding during elective cardiac surgery
Post-operative Monitoring
Monitoring for complications such as myocardial infarction, heart failure, and other secondary outcomes
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Fresh Autologous whole Blood (Procedure)
- Standard of Care Expectant management of bleeding (Behavioural Intervention)
Fresh Autologous whole Blood is already approved in United States, European Union, Canada for the following indications:
- Cardiac surgery
- Elective surgeries with high risk of bleeding
- Cardiac surgery
- Elective surgeries with high risk of bleeding
- Rare blood types or specific blood matching needs
- Cardiac surgery
- Elective surgeries with high risk of bleeding
- Patients with specific blood matching needs