Fresh Autologous Whole Blood Transfusion After Cardiopulmonary Bypass

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

Study Overview

• Status: Recruiting
• Conditions: Cardiac Disease; Bleeding Postoperative
• Intervention / Treatment: Other: Fresh Autologous whole Blood; Other: Standard of Care Expectant management of bleeding

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nathan J Clendenen, M.D.; Phone Number: 720-848-6709; Email: nathan.clendenen@cuanschutz.edu
• Study Contact Backup: Name: Nick Naughton, B.A; Phone Number: 720-848-6709; Email: nick.naughton@cuanschutz.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Hospital
      • Contact: Nathan Clendenen, MD MS
      • Principal Investigator: Nathan J Clendenen, MD MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fresh Autologous whole blood transfusion; 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.	Other: Fresh Autologous whole Blood; Subjects randomized this arm will receive fresh autologous whole blood
Active Comparator: 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	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of allogenic transfusions given	Allogenic blood product transfusion requirements	31 days
Severity of peri-operative stroke	The severity of peri-operative stroke will be measured by the National institute of health stroke scale	31 days
Incident of peri-operative stroke	The incident of peri-operative stroke will be measured by the National institute of health stroke scale	31 days
Development of Post-operative delirium	Measured by Confusion Assessment Method - Intensive Care Unit	31 days
Development of Myocardial Infarction	As measured by physiological parameters	31 days
Development of Heart failure	As measured by physiological parameters	31 days
Detection of New Onset Atrial fibrillation	As measured by an electrocardiogram	31 days
Development of Lung injury	Measured by a Pa02/Fi02 ratio	31 days
Time to extubation	Time from when the breathing tube was placed to the time when the breathing tube is removed	31 days
Development of Acute Kidney Injury	As measured by abnormal lab values	31 days
Initiation of renal replacement therapy	Time to start of renal replacement therapy	31 days
ICU length of stay	This will be measured by the number of days in ICU	31 days
Evaluation of Vasopressor requirements (1)	Measurement of the amount of vasopressors given	31 days
Evaluation of Vasopressor requirements (2)	Measurement of the types of vasopressors given	31 days
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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Nathan Clendenen, M.D., University of Colorado - School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2022
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: June 27, 2017
• First Submitted That Met QC Criteria: June 29, 2017
• First Posted (Actual): July 2, 2017

Study Record Updates

• Last Update Posted (Actual): November 21, 2024
• Last Update Submitted That Met QC Criteria: November 18, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Cardiac surgery
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Hemorrhage; Heart Diseases; Postoperative Hemorrhage
• Other Study ID Numbers: 16-2647

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No