Cleansing of Suction Blood in Cardiac Surgery for Reduced Inflammatory Response

NCT00159926 | Terminated Phase 3

• 4 other identifiers: 959583153961501172DHF: 03-2-3-35-22109CHC: 20/fo03
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Inflammatory Response Syndrome; Coronary Arteriosclerosis

Keywords

systemic inflammatory response syndrome; coronary artery bypass grafting; cell saver; interleukins; tumor necrosis factor alfa

Outcome Measures

Primary Outcomes (1)

• Concentrations of IL-1B, IL-6, IL-8, IL-10, IL-12p70, TNFa, TNF-R1, TNF-R2, PCT and LPS in patient blood.

  6, 24 and 72 hours after termination of CPB.

Secondary Outcomes (3)

• Bleeding

  Intra- and postoperatively

• Need for allogenic blood transfusions and blood products

  Within submission

• Clinical effect focusing on known complications to cardiac surgery and CPB

  Within submission

Study Arms (2)

1

EXPERIMENTAL

With cell saver

Procedure: Cell saver

2

ACTIVE COMPARATOR

Without cell saver

Procedure: No cell saver

Interventions

Cell saver PROCEDURE

Cell saver intraoperatively for coronary artery bypass grafting using cardiopulmonary bypass

1

No cell saver PROCEDURE

Conventional suction for coronary artery bypass grafting using cardiopulmonary bypass

2

Eligibility Criteria

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

You may qualify if:

• Oral and written informed consent.
• No limits regarding age or ejection fraction.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Danish Heart Foundation: collaborator
• Copenhagen Hospital Corporation: collaborator

Study Sites (1)

Department of Cardiothoracic Surgery, Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Systemic Inflammatory Response Syndrome; Coronary Artery Disease

Interventions

Operative Blood Salvage

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Tissue and Organ Harvesting; Transplantation; Surgical Procedures, Operative

Study Officials

• Sune Damgaard, MD

  Dept. of Cardiothoracic Surgery, Rigshospitalet, Copenhagen

  PRINCIPAL INVESTIGATOR

• Daniel A Steinbrüchel, Professor

  Dept. of Cardiothoracic Surgery, Rigshospitalet, Copenhagen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: January 1, 2003
• Study Completion: February 1, 2004
• Last Updated: January 14, 2008

Record last verified: 2007-11

Locations

DK (1)