Cell Savers and Blood Quality

NCT02046824 | Terminated

• 1 other identifier: Cell Saver-001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Bypass, Off-Pump

Outcome Measures

Primary Outcomes (1)

• 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.

  during operation

Secondary Outcomes (3)

• microcirculatory blood flow

  during operation

• Tissue oxygenation

  during operation

• Organ damage

  during hospital stay after surgery

Study Arms (4)

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.

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.

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.

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.

Other: no use of cell saver

Interventions

Xtra®, Sorin cellsaver DEVICE

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.

Xtra®, Sorin cellsaver

C.A.T.S.®, Fresenius cellsaver DEVICE

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 cellsaver

CardioPAT®, Haemonetics, cellsaver DEVICE

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, 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.

no use of cell saver

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, Provincie Groningen, 9713EZ, Netherlands

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.dr.

Study Record Dates

• First Submitted: January 20, 2014
• First Posted: January 28, 2014
• Study Start: January 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 16, 2016

Record last verified: 2016-12

Locations

NL (1)