Recruiting

Blood Transfusion

Sponsor:

University of Colorado, Denver

Code:

NCT03204357

Conditions

Cardiac Disease

Bleeding Postoperative

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Fresh Autologous whole Blood

Standard of Care Expectant management of bleeding

Study Details

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

Study ID

NCT03204357

Start date

Jan 24, 2022

Status verified date

Nov, 2024

Completion date

Sep, 2026

Anticipated

Primary completion date

Aug, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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

Interventions

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

Primary outcome measure

  • Estimated Blood Loss [ Time Frame: Within 24 hours after surgery ]

Central Contacts and Locations

Central contacts

Nathan J Clendenen, M.D.

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

Nick Naughton, B.A

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

Locations

University of Colorado Hospital

Recruiting

Aurora, Colorado, United States, 80045

Principal Investigator:

Nathan J Clendenen, MD MS

More Information

Sponsor

University of Colorado, Denver

Last update posted

Nov 21, 2024

Last verified

Nov, 2024

Keywords

  • Cardiac surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2024-11-21.