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Trial record 3 of 72 for:    SAVER

Cell Savers and Blood Quality

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ClinicalTrials.gov Identifier: NCT02046824
Recruitment Status : Terminated
First Posted : January 28, 2014
Last Update Posted : December 16, 2016
Sponsor:
Information provided by (Responsible Party):
Prof.dr.T.W.L.Scheeren, University Medical Center Groningen

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Coronary Artery Bypass, Off-Pump Device: Xtra®, Sorin cellsaver Device: C.A.T.S.®, Fresenius cellsaver Device: CardioPAT®, Haemonetics, cellsaver Other: no use of cell saver Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Diagnostic
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
Study Start Date : January 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Xtra®, Sorin cellsaver
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.
Device: Xtra®, Sorin cellsaver
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.

Experimental: C.A.T.S.®, Fresenius cellsaver
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.
Device: C.A.T.S.®, Fresenius cellsaver
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.

Experimental: CardioPAT®, Haemonetics, cellsaver
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.
Device: CardioPAT®, Haemonetics, cellsaver
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 saver
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.
Other: no use of cell saver
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. microcirculatory blood flow [ Time Frame: during operation ]
    The effects of of retransfusion of washed cell saver blood of either device in the patient measured by microcirculatory blood flow.

  2. Tissue oxygenation [ Time Frame: during operation ]
    Effects of retransfusion of washed cell saver blood of either device in the patient measured by tissue oxygenation

  3. Organ damage [ Time Frame: during hospital stay after surgery ]
    The effects of of retransfusion of washed cell saver blood of either device in the patient measured by biochemical markers of organ damage.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Scheduled for OPCABG surgery
  • Age > 18 years
  • Informed consent

Exclusion Criteria:

  • 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02046824


Locations
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Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9713EZ
Sponsors and Collaborators
University Medical Center Groningen

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Responsible Party: Prof.dr.T.W.L.Scheeren, Prof.dr., University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT02046824    
Other Study ID Numbers: Cell Saver-001
First Posted: January 28, 2014    Key Record Dates
Last Update Posted: December 16, 2016
Last Verified: December 2016