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
NCT Number: NCT03204357
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.
Interested in participating?
Request Info18 year–90 year
All sexes
Interventional
Not applicable
Aurora, Colorado, 80045, United States
Location status: Recruiting
Nathan Clendenen, MD MS
CONTACT
Nathan J Clendenen, MD MS
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects randomized this arm will receive fresh autologous whole blood
the control group that will receive the standard of care expectant management of bleeding and transfusion of allogenic banked blood products
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.
Time frame: 31 days
Allogenic blood product transfusion requirements
Time frame: 31 days
The severity of peri-operative stroke will be measured by the National institute of health stroke scale
Time frame: 31 days
The incident of peri-operative stroke will be measured by the National institute of health stroke scale
Time frame: 31 days
Measured by Confusion Assessment Method - Intensive Care Unit
Time frame: 31 days
As measured by physiological parameters
Time frame: 31 days
As measured by physiological parameters
Time frame: 31 days
As measured by an electrocardiogram
Time frame: 31 days
Measured by a Pa02/Fi02 ratio
Time frame: 31 days
Time from when the breathing tube was placed to the time when the breathing tube is removed
Time frame: 31 days
As measured by abnormal lab values
Time frame: 31 days
Time to start of renal replacement therapy
Time frame: 31 days
This will be measured by the number of days in ICU
Time frame: 31 days
Measurement of the amount of vasopressors given
Time frame: 31 days
Measurement of the types of vasopressors given
Time frame: 24 hours after surgery
Measurement of brachial artery dilation in response to flow by ultrasonography
Contact information is provided by the study sponsor or research team.
Nathan J Clendenen, M.D.
CONTACT
Nick Naughton, B.A
CONTACT
University of Colorado, Denver
Other
Targeted Fresh Autologous Whole Blood Transfusion After Cardiopulmonary Bypass: a Prospective Randomized Controlled Trial.
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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