Cleansing of Suction Blood in Cardiac Surgery for Reduced Inflammatory Response
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00159926 |
Recruitment Status
:
Terminated
(For financial and logistical reasons)
First Posted
: September 12, 2005
Last Update Posted
: January 14, 2008
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Systemic Inflammatory Response Syndrome Coronary Arteriosclerosis | Procedure: Cell saver Procedure: No cell saver | Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Does Cleansing of Suction Blood During Cardiac Surgery With Heart and Lung Machine Reduce the Postoperative Inflammatory Response ? |
Study Start Date : | January 2003 |
Actual Study Completion Date : | February 2004 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
With cell saver
|
Procedure: Cell saver
Cell saver intraoperatively for coronary artery bypass grafting using cardiopulmonary bypass
|
Active Comparator: 2
Without cell saver
|
Procedure: No cell saver
Conventional suction for coronary artery bypass grafting using cardiopulmonary bypass
|
- Concentrations of IL-1B, IL-6, IL-8, IL-10, IL-12p70, TNFa, TNF-R1, TNF-R2, PCT and LPS in patient blood. [ Time Frame: 6, 24 and 72 hours after termination of CPB. ]
- Bleeding [ Time Frame: Intra- and postoperatively ]
- Need for allogenic blood transfusions and blood products [ Time Frame: Within submission ]
- Clinical effect focusing on known complications to cardiac surgery and CPB [ Time Frame: Within submission ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Oral and written informed consent.
- No limits regarding age or ejection fraction.
Exclusion Criteria:
- Off-pump coronary artery bypass grafting
- Redo CABG
- Current infection
- Antibiotic treatment
- S-creatinin > 200 micromol/L
- Antiinflammatory / immuno-modulating treatment: Steroids, immunosuppressive or -stimulating agents (NSAIDs and ASA allowed)
- Liver disease
- Immune disease

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): NCT00159926
Denmark | |
Department of Cardiothoracic Surgery, Rigshospitalet | |
Copenhagen, Denmark, 2100 |
Principal Investigator: | Sune Damgaard, MD | Dept. of Cardiothoracic Surgery, Rigshospitalet, Copenhagen | |
Study Director: | Daniel A Steinbrüchel, Professor | Dept. of Cardiothoracic Surgery, Rigshospitalet, Copenhagen |
ClinicalTrials.gov Identifier: | NCT00159926 History of Changes |
Other Study ID Numbers: |
959583153 961501172 DHF: 03-2-3-35-22109 CHC: 20/fo03 |
First Posted: | September 12, 2005 Key Record Dates |
Last Update Posted: | January 14, 2008 |
Last Verified: | November 2007 |
Keywords provided by Rigshospitalet, Denmark:
systemic inflammatory response syndrome coronary artery bypass grafting cell saver interleukins tumor necrosis factor alfa |
Additional relevant MeSH terms:
Arteriosclerosis Systemic Inflammatory Response Syndrome Coronary Artery Disease Myocardial Ischemia Arterial Occlusive Diseases Vascular Diseases |
Cardiovascular Diseases Inflammation Pathologic Processes Shock Coronary Disease Heart Diseases |