Investigation of Leukocyte Trafficking Into Skin Blisters During Cardiopulmonary Bypass

Ischemic Heart Disease Clinical Trial

Official title:

Investigation of Leukocyte Trafficking Into Skin Blisters During Cardiopulmonary Bypass

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00131040
• Other study ID #: FS/03/065/15951
• Status: Completed
• Phase: N/A
• First received: August 15, 2005
• Last updated: May 27, 2015
• Start date: January 2003
• Est. completion date: June 2005

Study information

• Verified date: August 2005
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina Pectoris
• Coronary Artery Disease
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Drug:
• Aprotinin

Locations

Country	Name	City	State
United Kingdom	Hammersmith Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
Imperial College London	British Heart Foundation

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

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. Epub 2003 Dec 1. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the number of extravasated leukocytes in the skin blisters pre- and post-operatively, in both the placebo and aprotinin treatment groups
Secondary	The activation status of the blister leukocytes and the level of soluble inflammatory mediators within the blister