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NCT Number: NCT03204357

Fresh Autologous Whole Blood Transfusion After Cardiopulmonary Bypass

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.

Recruiting

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location status: Recruiting

Location contact

Nathan Clendenen, MD MS

CONTACT

Nathan J Clendenen, MD MS

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Fresh Autologous whole Blood

Other

Subjects randomized this arm will receive fresh autologous whole blood

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

Primary outcomes

  1. Estimated Blood Loss

    Time frame: Within 24 hours after surgery

    Blood loss is estimated as a percent of total estimated blood volume in the first 24 hours after cardiac surgery.

Secondary outcomes

  1. Number of allogenic transfusions given

    Time frame: 31 days

    Allogenic blood product transfusion requirements

  2. Severity of peri-operative stroke

    Time frame: 31 days

    The severity of peri-operative stroke will be measured by the National institute of health stroke scale

  3. Incident of peri-operative stroke

    Time frame: 31 days

    The incident of peri-operative stroke will be measured by the National institute of health stroke scale

  4. Development of Post-operative delirium

    Time frame: 31 days

    Measured by Confusion Assessment Method - Intensive Care Unit

  5. Development of Myocardial Infarction

    Time frame: 31 days

    As measured by physiological parameters

  6. Development of Heart failure

    Time frame: 31 days

    As measured by physiological parameters

  7. Detection of New Onset Atrial fibrillation

    Time frame: 31 days

    As measured by an electrocardiogram

  8. Development of Lung injury

    Time frame: 31 days

    Measured by a Pa02/Fi02 ratio

  9. Time to extubation

    Time frame: 31 days

    Time from when the breathing tube was placed to the time when the breathing tube is removed

  10. Development of Acute Kidney Injury

    Time frame: 31 days

    As measured by abnormal lab values

  11. Initiation of renal replacement therapy

    Time frame: 31 days

    Time to start of renal replacement therapy

  12. ICU length of stay

    Time frame: 31 days

    This will be measured by the number of days in ICU

  13. Evaluation of Vasopressor requirements (1)

    Time frame: 31 days

    Measurement of the amount of vasopressors given

  14. Evaluation of Vasopressor requirements (2)

    Time frame: 31 days

    Measurement of the types of vasopressors given

  15. Change in endothelial function measured by flow mediated dilation of the brachial artery

    Time frame: 24 hours after surgery

    Measurement of brachial artery dilation in response to flow by ultrasonography

Study contacts

Contact information is provided by the study sponsor or research team.

Nathan J Clendenen, M.D.

CONTACT

[email protected]

720-848-6709

Nick Naughton, B.A

CONTACT

[email protected]

720-848-6709

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Jul 2, 2017
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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