Coronary Artery Bypass, Off-PumpNCT02046824
Cell Savers and Blood Quality
A study testing Xtra®, Sorin cellsaver, C.A.T.S.®, Fresenius cellsaver and CardioPAT®, Haemonetics, cellsaver in people with Coronary Artery Bypass, Off-Pump, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
Cell savers are routinely used in our hospital during off-pump coronary artery bypass grafting to retrieve and wash blood that is lost during the operation. This washed blood is retransfused to the patient in order to prevent allogeneic blood transfusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Bypass, Off-Pump
- What is being tested?
- Xtra®, Sorin cellsaver, C.A.T.S.®, Fresenius cellsaver and CardioPAT®, Haemonetics, cellsaver
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2014to Dec 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for OPCABG surgery
- Age > 18 years
- Informed consent
Who cannot join
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Patients with known hematologic or microvascular disorders. Patients will be excluded intraoperatively when conversion to on-pump coronary artery bypass grafting is necessary or when allogeneic red blood cell transfusion is required.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Medical Center Groningen
Groningen, Provincie Groningen, 9713EZ
About this study
Official title: The Rheologic Properties and Oxygen Transport Capacity of Red Blood Cells Processed by 3 Different Types of Cell Saving, and Its Effects on Microcirculatory Blood Flow and Tissue Oxygenation in Vivo
Cell savers are routinely used in our hospital during off-pump coronary artery bypass grafting to retrieve and wash blood that is lost during the operation. This washed blood is retransfused to the patient in order to prevent allogeneic blood transfusion. However, little is known about the rheologic properties and oxygen transport capacity of the washed red blood cells and the effects of retransfusion of this blood on microcirculatory blood flow and organ damage in the patient. For cell savers 3 different operating principles exist. The most common one uses discontinuous blood washing with a spinning bowl that is intermittently filled with blood, processed and emptied. A second one uses a continuous blood washing principle with a rotational disk. A third one is intermediate using features of both the discontinuous bowl technology and the continuous rotational disc technology.
The investigator hypothesize that the operating principle has effects on the rheologic properties and oxygen transport capacity of the washed blood.
Previous research suggested that in particular the deformability and oxygen carrier properties of the red blood cells are affected. As a consequence, red blood cells may block small blood vessels, which affects microcirculatory blood flow and tissue oxygenation. This may lead to organ damage.
Read the detailed description
Cell savers are routinely used in our hospital during off-pump coronary artery bypass grafting (OPCABG) to retrieve and wash blood that is lost during the operation. This washed blood is retransfused to the patient in order to prevent allogeneic blood transfusion.
For cell savers 3 different operating principles exist. The most common type uses discontinuous blood processing with a spinning bowl that is intermittently filled with blood, processed and emptied. A second type uses a continuous blood processing principle with a rotational disk. A third one is intermediate using features of both the discontinuous bowl technology and the continuous rotational disc technology. In all types of autotransfusion systems the wound blood is washed, concentrated and stored in a blood conservation bag.
In several studies hemoglobin levels, leucocyte and platelet counts in the washed cell saver blood have been measured, indicating differences between types of cell saving. In other studies biochemical markers of inflammation in the washed cell saver blood have been measured, also indicating differences between types of cell saving. Recently, blood bank blood at the end of its shelf life was washed using similar devices as proposed in this study. The investigated devices removed substances from the blood differently. However, the rheologic properties of the red blood cells were not assessed.
Despite widespread clinical use of cell savers, little is therefore known about the rheologic properties and oxygen transport capacity of the washed red blood cells. As the process of washing of the blood cells occurs with high centrifugal loads, there is concern about the elasticity and deformability of the processed red blood cells. Ultrastructural changes in cell saver washed red blood cells have been demonstrated using scanning electron microscopy suggesting poor performance of these cells in the microcirculation. Using the continuous type of cell saver, we previously could demonstrate a reduction in deformability and 2,3-Diphosphoglycerate (DPG) levels of the processed blood cells. The implication is that microcirculatory blood flow may be obstructed by blockage of the small blood vessels and, as 2,3-DPG regulates oxygen transfer, tissue oxygenation may also be hampered. However, at the moment the effects of retransfusion of the washed cell saver blood on microcirculatory blood flow and tissue oxygenation in patients are unknown.
Thus, in this study the investigator want to determine in vitro the rheologic properties and oxygen transport capacity of the washed blood processed by one of 3 different types of cell saving (discontinuous, continuous and mixed) and to measure in vivo after retransfusion of this processed blood in the patient the effects on microcirculatory blood flow, tissue oxygenation and organ damage using organ specific biomarkers.
- Conditions
- Coronary Artery Bypass, Off-Pump
- Being tested
- Xtra®, Sorin cellsaver, C.A.T.S.®, Fresenius cellsaver, CardioPAT®, Haemonetics, cellsaver, no use of cell saver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xtra®, Sorin cellsaverDevice
when at least 750 mL of wound blood is collected in the reservoir during the operation, the washing process will be started using one of the three cell savers (see above). Samples will be taken from before and after the washing process. Thereafter, the blood will be retransfused to the patient.
C.A.T.S.®, Fresenius cellsaverDevice
when at least 750 mL of wound blood is collected in the reservoir during the operation, the washing process will be started using one of the three cell savers (see above). Samples will be taken from before and after the washing process. Thereafter, the blood will be retransfused to the patient.
CardioPAT®, Haemonetics, cellsaverDevice
when at least 750 mL of wound blood is collected in the reservoir during the operation, the washing process will be started using one of the three cell savers (see above). Samples will be taken from before and after the washing process. Thereafter, the blood will be retransfused to the patient.
no use of cell saverOther
When less than 750 ml of wound blood is collected in the reservoir at the end of the operation, patients will be automatically allocated to the control group. The collected blood will be cast away according to daily clinical practice and recommendations of the manufacturers.
| Study group | Role | What they receive |
|---|---|---|
| Xtra®, Sorin cellsaver | Experimental | when at least 750 mL of wound blood is collected in the reservoir during the operation, and when the patients has been allocated to the Xtra Sorin cellsaver group, the washing process will be started. Samples will be taken from before and after the washing process. Thereafter, the blood will be retransfused to the patient. Receives: Device: Xtra®, Sorin cellsaver |
| C.A.T.S.®, Fresenius cellsaver | Experimental | when at least 750 mL of wound blood is collected in the reservoir during the operation, and when the patients has been allocated to the C.A.T.S. cellsaver group, the washing process will be started. Samples will be taken from before and after the washing process. Thereafter, the blood will be retransfused to the patient. Receives: Device: C.A.T.S.®, Fresenius cellsaver |
| CardioPAT®, Haemonetics, cellsaver | Experimental | when at least 750 mL of wound blood is collected in the reservoir during the operation, and when the patients has been allocated to the CardioPAT cellsaver group, the washing process will be started. Samples will be taken from before and after the washing process. Thereafter, the blood will be retransfused to the patient. Receives: Device: CardioPAT®, Haemonetics, cellsaver |
| no use of cell saver | Other | When less than 750 ml of wound blood is collected in the reservoir at the end of the operation, patients will be automatically allocated to the control group. The collected blood will be cast away according to daily clinical practice and recommendations of the manufacturers. Receives: Other: no use of cell saver |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of the washed red blood cells, measured by their deformability and oxygen carrying capacity
Changes in elongation index, aggregation index, and 2,3-DPG and ATP levels of the washed red blood cells processed by one of 3 different cell savers.
Measured: during operation
Secondary outcomes (3)
microcirculatory blood flow
The effects of of retransfusion of washed cell saver blood of either device in the patient measured by microcirculatory blood flow.
Measured: during operation
Tissue oxygenation
Effects of retransfusion of washed cell saver blood of either device in the patient measured by tissue oxygenation
Measured: during operation
Organ damage
The effects of of retransfusion of washed cell saver blood of either device in the patient measured by biochemical markers of organ damage.
Measured: during hospital stay after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Bypass, Off-PumpStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof.dr.T.W.L.Scheeren, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02046824
- Sponsor's protocol ID
- Cell Saver-001
- Status last verified
- Dec 2016
- First submitted
- 20 Jan 2014
- Last updated
- 16 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Rheologic Properties and Oxygen Transport Capacity of Red Blood Cells Processed by 3 Different Types of Cell Saving, and Its Effects on Microcirculatory Blood Flow and Tissue Oxygenation in Vivo
- ClinicalTrials.gov ID
- NCT02046824
- Acronym / sponsor ID
- Cell Saver-001
- Conditions
- Coronary Artery Bypass, Off-Pump
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 28 Jan 2014 (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.
Cell savers are routinely used in our hospital during off-pump coronary artery bypass grafting to retrieve and wash blood that is lost during the operation. This washed blood is retransfused to the patient in order to prevent allogeneic blood transfusion. However, little is known about the rheologic properties and oxygen transport capacity of the washed red blood cells and the effects of retransfusion of this blood on microcirculatory blood flow and organ damage in the patient. For cell savers 3 different operating principles exist. The most common one uses discontinuous blood washing with a spinning bowl that is intermittently filled with blood, processed and emptied. A second one uses a continuous blood washing principle with a rotational disk. A third one is intermediate using features of both the discontinuous bowl technology and the continuous rotational disc technology.
The investigator hypothesize that the operating principle has effects on the rheologic properties and oxygen transport capacity of the washed blood.
Previous research suggested that in particular the deformability and oxygen carrier properties of the red blood cells are affected. As a consequence, red blood cells may block small blood vessels, which affects microcirculatory blood flow and tissue oxygenation. This may lead to organ damage.
Detailed description
Cell savers are routinely used in our hospital during off-pump coronary artery bypass grafting (OPCABG) to retrieve and wash blood that is lost during the operation. This washed blood is retransfused to the patient in order to prevent allogeneic blood transfusion.
For cell savers 3 different operating principles exist. The most common type uses discontinuous blood processing with a spinning bowl that is intermittently filled with blood, processed and emptied. A second type uses a continuous blood processing principle with a rotational disk. A third one is intermediate using features of both the discontinuous bowl technology and the continuous rotational disc technology. In all types of autotransfusion systems the wound blood is washed, concentrated and stored in a blood conservation bag.
In several studies hemoglobin levels, leucocyte and platelet counts in the washed cell saver blood have been measured, indicating differences between types of cell saving. In other studies biochemical markers of inflammation in the washed cell saver blood have been measured, also indicating differences between types of cell saving. Recently, blood bank blood at the end of its shelf life was washed using similar devices as proposed in this study. The investigated devices removed substances from the blood differently. However, the rheologic properties of the red blood cells were not assessed.
Despite widespread clinical use of cell savers, little is therefore known about the rheologic properties and oxygen transport capacity of the washed red blood cells. As the process of washing of the blood cells occurs with high centrifugal loads, there is concern about the elasticity and deformability of the processed red blood cells. Ultrastructural changes in cell saver washed red blood cells have been demonstrated using scanning electron microscopy suggesting poor performance of these cells in the microcirculation. Using the continuous type of cell saver, we previously could demonstrate a reduction in deformability and 2,3-Diphosphoglycerate (DPG) levels of the processed blood cells. The implication is that microcirculatory blood flow may be obstructed by blockage of the small blood vessels and, as 2,3-DPG regulates oxygen transfer, tissue oxygenation may also be hampered. However, at the moment the effects of retransfusion of the washed cell saver blood on microcirculatory blood flow and tissue oxygenation in patients are unknown.
Thus, in this study the investigator want to determine in vitro the rheologic properties and oxygen transport capacity of the washed blood processed by one of 3 different types of cell saving (discontinuous, continuous and mixed) and to measure in vivo after retransfusion of this processed blood in the patient the effects on microcirculatory blood flow, tissue oxygenation and organ damage using organ specific biomarkers.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Xtra®, Sorin cellsaver | Experimental | Device: Xtra®, Sorin cellsaverwhen at least 750 mL of wound blood is collected in the reservoir during the operation, and when the patients has been allocated to the Xtra Sorin cellsaver group, the washing process will be started. Samples will be taken from before and after the washing process. Thereafter, the blood will be retransfused to the patient. |
| C.A.T.S.®, Fresenius cellsaver | Experimental | Device: C.A.T.S.®, Fresenius cellsaverwhen at least 750 mL of wound blood is collected in the reservoir during the operation, and when the patients has been allocated to the C.A.T.S. cellsaver group, the washing process will be started. Samples will be taken from before and after the washing process. Thereafter, the blood will be retransfused to the patient. |
| CardioPAT®, Haemonetics, cellsaver | Experimental | Device: CardioPAT®, Haemonetics, cellsaverwhen at least 750 mL of wound blood is collected in the reservoir during the operation, and when the patients has been allocated to the CardioPAT cellsaver group, the washing process will be started. Samples will be taken from before and after the washing process. Thereafter, the blood will be retransfused to the patient. |
| no use of cell saver | Other | Other: no use of cell saverWhen less than 750 ml of wound blood is collected in the reservoir at the end of the operation, patients will be automatically allocated to the control group. The collected blood will be cast away according to daily clinical practice and recommendations of the manufacturers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Scheduled for OPCABG surgery
- Age > 18 years
- Informed consent
Key exclusion criteria (2 listed)
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Patients with known hematologic or microvascular disorders. Patients will be excluded intraoperatively when conversion to on-pump coronary artery bypass grafting is necessary or when allogeneic red blood cell transfusion is required.
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 |
|---|---|---|
| Xtra®, Sorin cellsaverwhen at least 750 mL of wound blood is collected in the reservoir during the operation, the washing process will be started using one of the three cell savers (see above). Samples will be taken from before and after the washing process. Thereafter, the blood will be retransfused to the patient. | Device | Xtra®, Sorin cellsaver |
| C.A.T.S.®, Fresenius cellsaverwhen at least 750 mL of wound blood is collected in the reservoir during the operation, the washing process will be started using one of the three cell savers (see above). Samples will be taken from before and after the washing process. Thereafter, the blood will be retransfused to the patient. | Device | C.A.T.S.®, Fresenius cellsaver |
| CardioPAT®, Haemonetics, cellsaverwhen at least 750 mL of wound blood is collected in the reservoir during the operation, the washing process will be started using one of the three cell savers (see above). Samples will be taken from before and after the washing process. Thereafter, the blood will be retransfused to the patient. | Device | CardioPAT®, Haemonetics, cellsaver |
| no use of cell saverWhen less than 750 ml of wound blood is collected in the reservoir at the end of the operation, patients will be automatically allocated to the control group. The collected blood will be cast away according to daily clinical practice and recommendations of the manufacturers. | Other | no use of cell saver |
Primary outcome
quality of the washed red blood cells, measured by their deformability and oxygen carrying capacity
Time frame: during operation
Changes in elongation index, aggregation index, and 2,3-DPG and ATP levels of the washed red blood cells processed by one of 3 different cell savers.
3 secondary outcomes
microcirculatory blood flow
Time frame: during operation
Tissue oxygenation
Time frame: during operation
Organ damage
Time frame: during hospital stay after surgery
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2016.
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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 Xtra®, Sorin cellsaver, C.A.T.S.®, Fresenius cellsaver and CardioPAT®, Haemonetics, cellsaver in people with Coronary Artery Bypass, Off-Pump, run by University Medical Center Groningen at 1 site in Netherlands.
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 3 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: stopped early, as of the sponsor's last update on 16 Dec 2016. 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 Netherlands. 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 was stopped early. Results are not available in the source record.
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?
quality of the washed red blood cells, measured by their deformability and oxygen carrying capacity (time frame: during operation). 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 16 Dec 2016.