Coronary Artery DiseaseNCT01416792
Centrifugation vs. Multiple-pass Hemofiltration of the Residual Cardiopulmonary Bypass Volume
A study testing Centrifugation and Multiple-pass hemofiltration in people with Coronary Artery Disease and Heart Valve Diseases, run by University of Saskatchewan at 1 site in Canada.
Trial summary
Traditional cardiac surgery requires patient connection to the Cardiopulmonary Bypass (CPB) apparatus which takes over the function of the heart and lungs while the surgeon performs the necessary surgery. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Coronary Artery Disease, Heart Valve Diseases
- What is being tested?
- Centrifugation and Multiple-pass hemofiltration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2011to Oct 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all males and females that will be receiving open heart surgery (Coronary Artery Bypass Grafts and / or Valve repair/replacement) during the study period.
Who cannot join
- history of bleeding disorders
- history inflammatory diseases rheumatoid arthritis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcomes & Biochemical Parameters Following Cardiac Surgery: Effects of Transfusion of Residual Blood Using Centrifugation and Multiple-Pass Hemofiltration
Traditional cardiac surgery requires patient connection to the Cardiopulmonary Bypass (CPB) apparatus which takes over the function of the heart and lungs while the surgeon performs the necessary surgery. The residual blood left in the CPB equipment (1.5-2.0 L) is centrifuged and washed leaving only red blood cells (RBCs) suspended in a saline solution. The RBCs are reinfused into the patient as needed by the anesthesiologist. The main problem with this technique is that many of the important components of the blood such as plasma proteins and clotting factors are discarded through cell washing. This study will explore a novel method (multiple-pass hemofiltration) of processing the residual pump blood which will allow the patient to receive their own whole blood with minimum waste of important components. The newer method of processing the residual pump volume has also been termed off-line modified ultrafiltration (off-line MUF) and is similar to the process that the kidneys use to filter the blood. It is hypothesized that multiple-pass hemofiltration of the residual CPB volume will reduce the occurrence of inflammatory responses, preserve plasma proteins, and decrease allogenic blood exposure and improve clinical outcomes as compared to centrifugation.
Read the detailed description
This study is being performed because the traditional method of recovery of the residual volume of blood from the cardiopulmonary bypass circuit involves centrifugation and washing of whole blood with a saline solution. This process is sufficient for the recovery of red blood cells however; it results in the discarding of other important components of the blood. The removal of white blood cells, plasma proteins and clotting factors may result in an increased risk of a adverse outcomes during the post-operative period. The new technique our team wants to investigate returns a greater proportion of the patients' whole blood for reinfusion. Our study objectives are to compare the two techniques and determine which technique produces the safest most reliable method of blood processing to help the patient have a smooth, short, transfusion free post-operative period in the intensive care unit (ICU).
- Conditions
- Coronary Artery Disease, Heart Valve Diseases
- Being tested
- Centrifugation, Multiple-pass hemofiltration
- Medical subject headings
- Coronary Artery Disease, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CentrifugationProcedure or surgery
Also called Cell washing
Multiple-pass hemofiltrationProcedure or surgery
Also called Hemofiltration
The residual volume from the CPB circuit is pumped though a hemofilter for multiple passes removing the crystalloid component thereby concentrating the plasma.
| Study group | Role | What they receive |
|---|---|---|
| Multiple-pass hemofiltration | Experimental | Not described Receives: Procedure: Centrifugation; Procedure: Multiple-pass hemofiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin
Serum hemoglobin will be measured from the patient at baseline, after hemodilution, and at 12-hours post-operatively in the ICU.
Measured: Baseline, Hemodilution and 12-hours post-operatively in ICU
Albumin
Serum albumin in g/L will be measured at baseline, hemodilution and 12-hours post-operatively in ICU.
Measured: baseline, hemodilution and 12-hours post-operatively in ICU
Total Protein
Serum total protein will be measured in g/L at the specified time intervals.
Measured: Baseline, hemodilution, and-12 hours post-operatively in ICU
Secondary outcomes (7)
Allogeneic blood products
The volume of allogeneic blood products will be recorded.
Measured: 12-hours post-operatively in ICU
Ventilation time
The time between intubation in OR and extubation in the ICU.
Measured: 12-hours post-operatively in ICU
Chest tube drainage
The total volume of chest tube drainage in ICU.
Measured: 12-hours post-operatively in ICU
Vasoactive Inotrope score
We will calculate the vasoactive inotrope score to determine if there is an increased risk of adverse outcomes.
Measured: 12-hours post-operatively in ICU
Length of stay in ICU
The average time of discharged from ICU.
Measured: Within 24 hours
Markers of inflammation
Inflammatory mediators: tumor necrosis factor alpha (TNF-alpha), soluble receptors for advanced glycation end products (sRAGE), and high sensitivity C-reactive protein (hs CRP).
Measured: At 12-hours ICU
Indicators of Kidney Function
Serum creatinine, creatinine clearance, volume of IV fluid intake, volume of urine output, fluid balance
Measured: 12-hours ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2011 (estimated)
- Study startMar 2011
- Primary completionSep 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- Saskatoon Health Region
- Responsible party
- Principal investigator, Erick McNair, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01416792
- Sponsor's protocol ID
- Multiple-pass hemofiltration
- Status last verified
- Sep 2011
- First submitted
- 7 Jun 2011
- Last updated
- 1 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes & Biochemical Parameters Following Cardiac Surgery: Effects of Transfusion of Residual Blood Using Centrifugation and Multiple-Pass Hemofiltration
- ClinicalTrials.gov ID
- NCT01416792
- Acronym / sponsor ID
- Multiple-pass hemofiltration
- Conditions
- Coronary Artery Disease, Heart Valve Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- Saskatoon Health Region
- Study start
- Mar 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 15 Aug 2011 (estimated)
- 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.
Traditional cardiac surgery requires patient connection to the Cardiopulmonary Bypass (CPB) apparatus which takes over the function of the heart and lungs while the surgeon performs the necessary surgery. The residual blood left in the CPB equipment (1.5-2.0 L) is centrifuged and washed leaving only red blood cells (RBCs) suspended in a saline solution. The RBCs are reinfused into the patient as needed by the anesthesiologist. The main problem with this technique is that many of the important components of the blood such as plasma proteins and clotting factors are discarded through cell washing. This study will explore a novel method (multiple-pass hemofiltration) of processing the residual pump blood which will allow the patient to receive their own whole blood with minimum waste of important components. The newer method of processing the residual pump volume has also been termed off-line modified ultrafiltration (off-line MUF) and is similar to the process that the kidneys use to filter the blood. It is hypothesized that multiple-pass hemofiltration of the residual CPB volume will reduce the occurrence of inflammatory responses, preserve plasma proteins, and decrease allogenic blood exposure and improve clinical outcomes as compared to centrifugation.
Detailed description
This study is being performed because the traditional method of recovery of the residual volume of blood from the cardiopulmonary bypass circuit involves centrifugation and washing of whole blood with a saline solution. This process is sufficient for the recovery of red blood cells however; it results in the discarding of other important components of the blood. The removal of white blood cells, plasma proteins and clotting factors may result in an increased risk of a adverse outcomes during the post-operative period. The new technique our team wants to investigate returns a greater proportion of the patients' whole blood for reinfusion. Our study objectives are to compare the two techniques and determine which technique produces the safest most reliable method of blood processing to help the patient have a smooth, short, transfusion free post-operative period in the intensive care unit (ICU).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multiple-pass hemofiltration | Experimental | Procedure: Centrifugation, Procedure: Multiple-pass hemofiltration |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all males and females that will be receiving open heart surgery (Coronary Artery Bypass Grafts and / or Valve repair/replacement) during the study period.
Key exclusion criteria (2 listed)
- history of bleeding disorders
- history inflammatory diseases rheumatoid arthritis
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 |
|---|---|---|
| CentrifugationAlso: Cell washing | Procedure or surgery | Multiple-pass hemofiltration |
| Multiple-pass hemofiltrationAlso: HemofiltrationThe residual volume from the CPB circuit is pumped though a hemofilter for multiple passes removing the crystalloid component thereby concentrating the plasma. | Procedure or surgery | Multiple-pass hemofiltration |
Primary outcome
Hemoglobin
Time frame: Baseline, Hemodilution and 12-hours post-operatively in ICU
Serum hemoglobin will be measured from the patient at baseline, after hemodilution, and at 12-hours post-operatively in the ICU.
Albumin
Time frame: baseline, hemodilution and 12-hours post-operatively in ICU
Serum albumin in g/L will be measured at baseline, hemodilution and 12-hours post-operatively in ICU.
Total Protein
Time frame: Baseline, hemodilution, and-12 hours post-operatively in ICU
Serum total protein will be measured in g/L at the specified time intervals.
7 secondary outcomes
Allogeneic blood products
Time frame: 12-hours post-operatively in ICU
Ventilation time
Time frame: 12-hours post-operatively in ICU
Chest tube drainage
Time frame: 12-hours post-operatively in ICU
Vasoactive Inotrope score
Time frame: 12-hours post-operatively in ICU
Length of stay in ICU
Time frame: Within 24 hours
Markers of inflammation
Time frame: At 12-hours ICU
Indicators of Kidney Function
Time frame: 12-hours ICU
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2013.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Centrifugation and Multiple-pass hemofiltration in people with Coronary Artery Disease and Heart Valve Diseases, run by University of Saskatchewan at 1 site in Canada.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 1 Apr 2013. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin (time frame: Baseline, Hemodilution and 12-hours post-operatively in ICU). The study lists 3 primary outcomes in all. 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 1 Apr 2013; AzTrials last refreshed its copy on 8 Nov 2026.