Investigation of Leukocyte Trafficking Into Skin Blisters During Cardiopulmonary Bypass

This study has been completed.
Sponsor:
Collaborator:
British Heart Foundation
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT00131040
First received: August 15, 2005
Last updated: October 6, 2005
Last verified: August 2005
  Purpose

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 Intervention
Ischemic Heart Disease
Angina Pectoris
Drug: Aprotinin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Investigation of Leukocyte Trafficking Into Skin Blisters During Cardiopulmonary Bypass

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • 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:
  • The activation status of the blister leukocytes and the level of soluble inflammatory mediators within the blister

Estimated Enrollment: 24
Study Start Date: January 2003
Estimated Study Completion Date: June 2005
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.

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00131040

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

Publications:
ClinicalTrials.gov Identifier: NCT00131040     History of Changes
Other Study ID Numbers: FS/03/065/15951
Study First Received: August 15, 2005
Last Updated: October 6, 2005
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:
Cardiopulmonary
Surgery
leukocyte
inflammation
Coronary Artery Bypass Grafting

Additional relevant MeSH terms:
Heart Diseases
Coronary Artery Disease
Myocardial Ischemia
Angina Pectoris
Cardiovascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2014