Fresh Autologous Whole Blood Transfusion After Cardiopulmonary Bypass

Cardiac Disease Clinical Trial

Official title:

Targeted Fresh Autologous Whole Blood Transfusion After Cardiopulmonary Bypass: a Prospective Randomized Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03204357
• Other study ID #: 16-2647
• Status: Recruiting
• Phase: N/A
• Start date: January 24, 2022
• Est. completion date: September 2026

Study information

• Verified date: March 2024
• Source: University of Colorado, Denver
• Contact: Nathan J Clendenen, M.D.
• Phone: 720-848-6709
• Email: nathan.clendenen[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Cardiac surgery carries a significant risk of bleeding requiring transfusion of stored blood products and blood transfusion associated with cardiac surgery consumes 20% of the blood supply worldwide. Although transfusion may be life-saving, significant risks of complications such as lung injury or even an increase in mortality are associated with transfusion. Decreasing transfusion requirements during cardiac surgery has the potential to reduce the rate of complications, improve patient outcomes, and reduce cost resulting in increased value for both the patient and the health system as a whole. Collection of autologous blood before cardiopulmonary bypass (CPB) for transfusion after CPB has been shown to be both safe and effective for reducing blood loss during cardiac surgery, but this intervention has not been targeted to a patient population at high risk for bleeding and transfusion. Fresh whole blood has the capacity to restore coagulation system function during profound coagulopathy in a trauma setting or following massive transfusion by an unknown mechanism. One unit of fresh whole blood is able to restore clotting function equivalent to that achieved by 10 units of pooled platelets. Autologous whole blood collection prior to CPB for transfusion post-operatively has been shown to improve coagulation and decrease clot lysis but is not routinely performed because 90% to 95% of patients do not have extensive blood loss and subsequent coagulopathy. Coupling accurate pre-operative bleeding risk prediction with autologous fresh whole blood collection for transfusion after CPB would target an established, low cost, low risk intervention to an at risk patient population who may experience significant benefit.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: September 2026
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Adult subjects aged 18 to 90

2. Able to provide informed consent

3. Willing to accept autologous or allogenic blood transfusion

4. Scheduled for elective cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

1. Pre-operative administration of allogenic blood bank products in the previous 3 months

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

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

4. Hemoglobin less than 7 g/dl

Related Conditions & MeSH terms

• Bleeding Postoperative
• Cardiac Disease
• Heart Diseases
• Postoperative Hemorrhage

Intervention

Other:
• Fresh Autologous whole Blood
Subjects randomized this arm will receive fresh autologous whole blood
• Standard of Care Expectant management of bleeding
the control group that will receive the standard of care expectant management of bleeding and transfusion of allogenic banked blood products

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimated Blood Loss	Blood loss is estimated as a percent of total estimated blood volume in the first 24 hours after cardiac surgery.	Within 24 hours after surgery
Secondary	Number of allogenic transfusions given	Allogenic blood product transfusion requirements	31 days
Secondary	Severity of peri-operative stroke	The severity of peri-operative stroke will be measured by the National institute of health stroke scale	31 days
Secondary	Incident of peri-operative stroke	The incident of peri-operative stroke will be measured by the National institute of health stroke scale	31 days
Secondary	Development of Post-operative delirium	Measured by Confusion Assessment Method - Intensive Care Unit	31 days
Secondary	Development of Myocardial Infarction	As measured by physiological parameters	31 days
Secondary	Development of Heart failure	As measured by physiological parameters	31 days
Secondary	Detection of New Onset Atrial fibrillation	As measured by an electrocardiogram	31 days
Secondary	Development of Lung injury	Measured by a Pa02/Fi02 ratio	31 days
Secondary	Time to extubation	Time from when the breathing tube was placed to the time when the breathing tube is removed	31 days
Secondary	Development of Acute Kidney Injury	As measured by abnormal lab values	31 days
Secondary	Initiation of renal replacement therapy	Time to start of renal replacement therapy	31 days
Secondary	ICU length of stay	This will be measured by the number of days in ICU	31 days
Secondary	Evaluation of Vasopressor requirements (1)	Measurement of the amount of vasopressors given	31 days
Secondary	Evaluation of Vasopressor requirements (2)	Measurement of the types of vasopressors given	31 days
Secondary	Change in endothelial function measured by flow mediated dilation of the brachial artery	Measurement of brachial artery dilation in response to flow by ultrasonography	24 hours after surgery