Cleansing of Suction Blood in Cardiac Surgery for Reduced Inflammatory Response

This study has been terminated.

(For financial and logistical reasons)

Sponsor:

Collaborators:

Danish Heart Foundation

Copenhagen Hospital Corporation

Information provided by:

Rigshospitalet, Denmark

ClinicalTrials.gov Identifier:

NCT00159926

First received: September 8, 2005

Last updated: January 4, 2008

Last verified: November 2007

History of Changes

Purpose

Cardiac surgery using heart and lung machine produces an inflammatory reaction in the body. This leads in few percent of cases to heart, lung, and kidney disturbances that potentially causes death. White blood cells in contact with the heart and lung machine and external surfaces release mediators partly responsible for this. Blood collected by the suction and the blood remaining in the heart and lung machine after its use, can be cleaned by a cell saver before reinfusion, and this might reduce the inflammatory response.

Condition	Intervention	Phase
Systemic Inflammatory Response Syndrome Coronary Arteriosclerosis	Procedure: Cell saver Procedure: No cell saver	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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 ?

Resource links provided by NLM:

MedlinePlus related topics: Heart Surgery

U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:

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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]


Enrollment:	30
Study Start Date:	January 2003
Study Completion Date:	February 2004

Arms	Assigned Interventions
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

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Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00159926

Locations


Denmark
Department of Cardiothoracic Surgery, Rigshospitalet
Copenhagen, Denmark, 2100

Sponsors and Collaborators

Rigshospitalet, Denmark

Danish Heart Foundation

Copenhagen Hospital Corporation

Investigators


Principal Investigator:	Sune Damgaard, MD	Dept. of Cardiothoracic Surgery, Rigshospitalet, Copenhagen
Study Director:	Daniel A Steinbrüchel, Professor	Dept. of Cardiothoracic Surgery, Rigshospitalet, Copenhagen

More Information


ClinicalTrials.gov Identifier:	NCT00159926 History of Changes
Other Study ID Numbers:	959583153 961501172 DHF: 03-2-3-35-22109 CHC: 20/fo03
Study First Received:	September 8, 2005
Last Updated:	January 4, 2008
Health Authority:	Denmark: The Regional Committee on Biomedical Research Ethics

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 Coronary Artery Disease Myocardial Ischemia Systemic Inflammatory Response Syndrome Arterial Occlusive Diseases Vascular Diseases	Cardiovascular Diseases Coronary Disease Heart Diseases Inflammation Pathologic Processes Shock

ClinicalTrials.gov processed this record on September 26, 2016

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