Clinical trial NCT00131040: 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
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Heart Disease
Angina Pectoris
Keywords: Cardiopulmonary
Surgery
leukocyte
inflammation
Coronary Artery Bypass Grafting
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: British Heart Foundation
First posted: 2005-08-17
Enrollment: 24
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Comparison of the number of extravasated leukocytes in the skin blisters pre- and post-operatively, in both the placebo and aprotinin treatment groups
Secondary outcomes:
measure: The activation status of the blister leukocytes and the level of soluble inflammatory mediators within the blister
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Hammersmith Hospital
Study officials:
affiliation: Hammersmith Hospital Campus, Imperial College
name: Kenneth M Taylor, MD, FRCS
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.