ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Collaborators:
Danish Heart Foundation
Copenhagen Hospital Corporation
Information provided by:
Rigshospitalet, Denmark

Study Description
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Systemic Inflammatory Response Syndrome Coronary Arteriosclerosis Procedure: Cell saver Procedure: No cell saver Phase 3

  Show Detailed Description

Study Design
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

Arms and Interventions
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. Bleeding [ Time Frame: Intra- and postoperatively ]
  2. Need for allogenic blood transfusions and blood products [ Time Frame: Within submission ]
  3. Clinical effect focusing on known complications to cardiac surgery and CPB [ Time Frame: Within submission ]

Eligibility Criteria
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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
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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): 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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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