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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:

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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
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
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

No publications provided

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 May 19, 2013