Cardiac DiseaseNCT03204357
Fresh Autologous Whole Blood Transfusion After Cardiopulmonary Bypass
A study testing Fresh Autologous whole Blood in people with Cardiac Disease and Bleeding Postoperative, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cardiac Disease, Bleeding Postoperative
- What is being tested?
- Fresh Autologous whole Blood
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2022to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Colorado Hospital
Aurora, Colorado, 80045
Nathan Clendenen, MD MS
Nathan J Clendenen, MD MS
About this study
Official title: Targeted Fresh Autologous Whole Blood Transfusion After Cardiopulmonary Bypass: a Prospective Randomized Controlled Trial.
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.
Read the 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.
- Conditions
- Cardiac Disease, Bleeding Postoperative
- Being tested
- Fresh Autologous whole Blood, Standard of Care Expectant management of bleeding
- Keywords
- Cardiac surgery
- Medical subject headings
- Heart Diseases, Postoperative Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fresh Autologous whole BloodOther
Subjects randomized this arm will receive fresh autologous whole blood
Standard of Care Expectant management of bleedingOther
the control group that will receive the standard of care expectant management of bleeding and transfusion of allogenic banked blood products
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Standard of Care Expectant management of bleeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated Blood Loss
Blood loss is estimated as a percent of total estimated blood volume in the first 24 hours after cardiac surgery.
Measured: Within 24 hours after surgery
Secondary outcomes (15)
Number of allogenic transfusions given
Allogenic blood product transfusion requirements
Measured: 31 days
Severity of peri-operative stroke
The severity of peri-operative stroke will be measured by the National institute of health stroke scale
Measured: 31 days
Incident of peri-operative stroke
The incident of peri-operative stroke will be measured by the National institute of health stroke scale
Measured: 31 days
Development of Post-operative delirium
Measured by Confusion Assessment Method - Intensive Care Unit
Measured: 31 days
Development of Myocardial Infarction
As measured by physiological parameters
Measured: 31 days
Development of Heart failure
As measured by physiological parameters
Measured: 31 days
Detection of New Onset Atrial fibrillation
As measured by an electrocardiogram
Measured: 31 days
Development of Lung injury
Measured by a Pa02/Fi02 ratio
Measured: 31 days
Time to extubation
Time from when the breathing tube was placed to the time when the breathing tube is removed
Measured: 31 days
Development of Acute Kidney Injury
As measured by abnormal lab values
Measured: 31 days
Initiation of renal replacement therapy
Time to start of renal replacement therapy
Measured: 31 days
ICU length of stay
This will be measured by the number of days in ICU
Measured: 31 days
Evaluation of Vasopressor requirements (1)
Measurement of the amount of vasopressors given
Measured: 31 days
Evaluation of Vasopressor requirements (2)
Measurement of the types of vasopressors given
Measured: 31 days
Change in endothelial function measured by flow mediated dilation of the brachial artery
Measurement of brachial artery dilation in response to flow by ultrasonography
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start24 Jan 2022
- Primary completionAug 2025 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathan Clendenen, M.D., Principal investigator, University of Colorado - School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03204357
- Sponsor's protocol ID
- 16-2647
- Status last verified
- Nov 2024
- First submitted
- 27 Jun 2017
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Fresh Autologous Whole Blood Transfusion After Cardiopulmonary Bypass: a Prospective Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03204357
- Acronym / sponsor ID
- 16-2647
- Conditions
- Cardiac Disease, Bleeding Postoperative
- Keywords
- Cardiac surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 24 Jan 2022 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 2 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Fresh Autologous whole blood transfusion | Experimental | Other: Fresh Autologous whole BloodThe 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. |
| Standard of Care Expectant Management of bleeding | Active comparator | Other: Standard of Care Expectant management of bleedingthe control group that will receive the standard of care expectant management of bleeding and transfusion of allogenic banked blood products |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fresh Autologous whole BloodSubjects randomized this arm will receive fresh autologous whole blood | Other | Fresh Autologous whole blood transfusion |
| Standard of Care Expectant management of bleedingthe 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 |
Primary outcome
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.
15 secondary outcomes
Number of allogenic transfusions given
Time frame: 31 days
Severity of peri-operative stroke
Time frame: 31 days
Incident of peri-operative stroke
Time frame: 31 days
Development of Post-operative delirium
Time frame: 31 days
Development of Myocardial Infarction
Time frame: 31 days
Development of Heart failure
Time frame: 31 days
Detection of New Onset Atrial fibrillation
Time frame: 31 days
Development of Lung injury
Time frame: 31 days
Time to extubation
Time frame: 31 days
Development of Acute Kidney Injury
Time frame: 31 days
Initiation of renal replacement therapy
Time frame: 31 days
ICU length of stay
Time frame: 31 days
Evaluation of Vasopressor requirements (1)
Time frame: 31 days
Evaluation of Vasopressor requirements (2)
Time frame: 31 days
Change in endothelial function measured by flow mediated dilation of the brachial artery
Time frame: 24 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nathan Clendenen, M.D. principal investigator
University of Colorado - School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fresh Autologous whole Blood in people with Cardiac Disease and Bleeding Postoperative, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nathan J Clendenen, M.D. (720-848-6709, nathan.clendenen@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimated Blood Loss (time frame: Within 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.