Investigation of Leukocyte Trafficking Into Skin Blisters During Cardiopulmonary Bypass

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00131040

Enrollment

Registered

2005-08-17

Start date

2003-01-31

Completion date

2005-06-30

Last updated

2015-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Angina Pectoris, Ischemic Heart Disease

Keywords

Cardiopulmonary, Surgery, leukocyte, inflammation, Coronary Artery Bypass Grafting

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.

Interventions

DRUGAprotinin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

30 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Comparison of the number of extravasated leukocytes in the skin blisters pre- and post-operatively, in both the placebo and aprotinin treatment groups	—

Secondary

Measure	Time frame
The activation status of the blister leukocytes and the level of soluble inflammatory mediators within the blister	—

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026