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Investigation of Leukocyte Trafficking Into Skin Blisters During Cardiopulmonary Bypass

Primary Purpose

Ischemic Heart Disease, Angina Pectoris

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Aprotinin
Sponsored by
Imperial College London
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Heart Disease focused on measuring Cardiopulmonary, Surgery, leukocyte, inflammation, Coronary Artery Bypass Grafting

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hammersmith Hospital

Outcomes

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

Full Information

First Posted
August 15, 2005
Last Updated
May 27, 2015
Sponsor
Imperial College London
Collaborators
British Heart Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00131040
Brief Title
Investigation of Leukocyte Trafficking Into Skin Blisters During Cardiopulmonary Bypass
Official Title
Investigation of Leukocyte Trafficking Into Skin Blisters During Cardiopulmonary Bypass
Study Type
Interventional

2. Study Status

Record Verification Date
August 2005
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Imperial College London
Collaborators
British Heart Foundation

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Disease, Angina Pectoris
Keywords
Cardiopulmonary, Surgery, leukocyte, inflammation, Coronary Artery Bypass Grafting

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
24 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Aprotinin
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
The activation status of the blister leukocytes and the level of soluble inflammatory mediators within the blister

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth M Taylor, MD, FRCS
Organizational Affiliation
Hammersmith Hospital Campus, Imperial College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hammersmith Hospital
City
London
ZIP/Postal Code
W12 0NN
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
15248227
Citation
Yagnik DR, Evans BJ, Florey O, Mason JC, Landis RC, Haskard DO. Macrophage release of transforming growth factor beta1 during resolution of monosodium urate monohydrate crystal-induced inflammation. Arthritis Rheum. 2004 Jul;50(7):2273-80. doi: 10.1002/art.20317.
Results Reference
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PubMed Identifier
14656926
Citation
Philippidis P, Mason JC, Evans BJ, Nadra I, Taylor KM, Haskard DO, Landis RC. Hemoglobin scavenger receptor CD163 mediates interleukin-10 release and heme oxygenase-1 synthesis: antiinflammatory monocyte-macrophage responses in vitro, in resolving skin blisters in vivo, and after cardiopulmonary bypass surgery. Circ Res. 2004 Jan 9;94(1):119-26. doi: 10.1161/01.RES.0000109414.78907.F9. Epub 2003 Dec 1.
Results Reference
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Investigation of Leukocyte Trafficking Into Skin Blisters During Cardiopulmonary Bypass

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