Investigation of Leukocyte Trafficking Into Skin Blisters During Cardiopulmonary Bypass

NCT ID: NCT00131040

Last Updated: 2015-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-01-31
• Study Completion Date: 2005-06-30

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.

Conditions

Ischemic Heart Disease; Angina Pectoris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Aprotinin

Intervention Type: DRUG

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

British Heart Foundation

OTHER

Sponsor Role: collaborator

Imperial College London

OTHER

Sponsor Role: lead

Principal Investigators

Kenneth M Taylor, MD, FRCS

Role: PRINCIPAL_INVESTIGATOR

Hammersmith Hospital Campus, Imperial College

Locations

Hammersmith Hospital

London, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 15248227 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14656926 (View on PubMed)

Other Identifiers

FS/03/065/15951

Identifier Type: -

Identifier Source: org_study_id