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Completed

NCT Number: NCT00131040

Investigation of Leukocyte Trafficking Into Skin Blisters During Cardiopulmonary Bypass

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.

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Key information

Conditions

Ischemic Heart Disease Angina Pectoris Cardiovascular Diseases Chest Pain Heart Diseases Inflammation Myocardial Ischemia Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hammersmith Hospital

London, W12 0NN, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aprotinin

Drug

Primary outcomes

  1. 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

  1. The activation status of the blister leukocytes and the level of soluble inflammatory mediators within the blister

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • British Heart Foundation

Registry information

Important dates

Study start
2003
Study completion
2005
First posted
Aug 17, 2005
Registry last updated
May 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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