Fresh Autologous Whole Blood Transfusion After Cardiopulmonary Bypass

NCT03204357 | Recruiting

• 1 other identifier: 16-2647
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiac Disease; Bleeding Postoperative

Keywords

Cardiac surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Number of allogenic transfusions given

  31 days

• Severity of peri-operative stroke

  31 days

• Incident of peri-operative stroke

  31 days

• Development of Post-operative delirium

  31 days

• Development of Myocardial Infarction

  31 days

Study Arms (2)

Fresh Autologous whole blood transfusion

EXPERIMENTAL

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

Standard of Care Expectant Management of bleeding

ACTIVE COMPARATOR

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

Interventions

Fresh Autologous whole Blood OTHER

Subjects randomized this arm will receive fresh autologous whole blood

Fresh Autologous whole blood transfusion

Standard of Care Expectant management of bleeding OTHER

the control group that will receive the standard of care expectant management of bleeding and transfusion of allogenic banked blood products

Standard of Care Expectant Management of bleeding

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You 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 may not qualify 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Heart Diseases; Postoperative Hemorrhage

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications

Study Officials

• Nathan Clendenen, M.D.

  University of Colorado - School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathan J Clendenen, M.D.

CONTACT

720-848-6709; nathan.clendenen@cuanschutz.edu

Nick Naughton, B.A

CONTACT

720-848-6709; nick.naughton@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: June 27, 2017
• First Posted: July 2, 2017
• Study Start: January 24, 2022
• Primary Completion: August 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)