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Investigation of Leukocyte Trafficking Into Skin Blisters During Cardiopulmonary Bypass

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. Identifier: NCT00131040
Recruitment Status : Completed
First Posted : August 17, 2005
Last Update Posted : May 28, 2015
British Heart Foundation
Information provided by:
Imperial College London

Brief Summary:
The purpose of this study was to see if the heart-lung machine involved in cardiac surgery increases the movement of activated white blood cells from the bloodstream into the patient's tissues and also to see if aprotinin usage during surgery reduces this effect.

Condition or disease Intervention/treatment
Ischemic Heart Disease Angina Pectoris Drug: Aprotinin

Detailed Description:

It has long been known that exposure of blood to the heart-lung bypass machine can trigger a whole-body inflammatory response in cardiac surgery patients that is linked to activation of circulating white blood cells. The investigators propose to use a technique to track the movement of white blood cells into the skin of patients during bypass surgery. The skin blisters will be elicited by application of the blistering agent cantharidin to the forearm of volunteer patients. This will allow the investigators to study the activation state of white blood cells that enter tissues during bypass surgery and to determine whether aprotinin has any beneficial effect with regards to inflammatory status of these cells.

The investigators propose that white blood cell trafficking into the blisters will increase following the use of the heart-lung machine and that the effect of aprotinin will be to ablate this.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Investigation of Leukocyte Trafficking Into Skin Blisters During Cardiopulmonary Bypass
Study Start Date : January 2003
Estimated Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Aprotinin
U.S. FDA Resources

Primary Outcome Measures :
  1. Comparison of the number of extravasated leukocytes in the skin blisters pre- and post-operatively, in both the placebo and aprotinin treatment groups

Secondary Outcome Measures :
  1. The activation status of the blister leukocytes and the level of soluble inflammatory mediators within the blister

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Primary elective coronary artery bypass surgery

Exclusion Criteria:

  • Emergent, urgent or re-do surgery
  • Patients on oral corticosteroid medication
  • Patients on aspirin therapy < 7 days prior to operation

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 identifier (NCT number): NCT00131040

United Kingdom
Hammersmith Hospital
London, United Kingdom, W12 0NN
Sponsors and Collaborators
Imperial College London
British Heart Foundation
Principal Investigator: Kenneth M Taylor, MD, FRCS Hammersmith Hospital Campus, Imperial College

Publications: Identifier: NCT00131040     History of Changes
Other Study ID Numbers: FS/03/065/15951
First Posted: August 17, 2005    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: August 2005

Keywords provided by Imperial College London:
Coronary Artery Bypass Grafting

Additional relevant MeSH terms:
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Angina Pectoris
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arterial Occlusive Diseases
Chest Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Skin Diseases, Vesiculobullous
Skin Diseases
Pathological Conditions, Anatomical
Trypsin Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action