Clinical trial NCT03204357: Fresh Autologous Whole Blood Transfusion After Cardiopulmonary Bypass
Official title: Targeted Fresh Autologous Whole Blood Transfusion After Cardiopulmonary Bypass: a Prospective Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiac Disease
Bleeding Postoperative
Keywords: Cardiac surgery
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Estimated Blood Loss
timeFrame: Within 24 hours after surgery
Secondary outcomes:
measure: Number of allogenic transfusions given
timeFrame: 31 days
measure: Severity of peri-operative stroke
timeFrame: 31 days
measure: Incident of peri-operative stroke
timeFrame: 31 days
measure: Development of Post-operative delirium
timeFrame: 31 days
measure: Development of Myocardial Infarction
timeFrame: 31 days
measure: Development of Heart failure
timeFrame: 31 days
measure: Detection of New Onset Atrial fibrillation
timeFrame: 31 days
measure: Development of Lung injury
timeFrame: 31 days
measure: Time to extubation
timeFrame: 31 days
measure: Development of Acute Kidney Injury
timeFrame: 31 days
measure: Initiation of renal replacement therapy
timeFrame: 31 days
measure: ICU length of stay
timeFrame: 31 days
measure: Evaluation of Vasopressor requirements (1)
timeFrame: 31 days
measure: Evaluation of Vasopressor requirements (2)
timeFrame: 31 days
measure: Change in endothelial function measured by flow mediated dilation of the brachial artery
timeFrame: 24 hours after surgery
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
affiliation: University of Colorado - School of Medicine
name: Nathan Clendenen, M.D.
role: PRINCIPAL_INVESTIGATOR
References: