Investigation of Leukocyte Trafficking Into Skin Blisters During Cardiopulmonary Bypass
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Ischemic Heart Disease Angina Pectoris |
Drug: Aprotinin |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Investigation of Leukocyte Trafficking Into Skin Blisters During Cardiopulmonary Bypass |
- Comparison of the number of extravasated leukocytes in the skin blisters pre- and post-operatively, in both the placebo and aprotinin treatment groups
- The activation status of the blister leukocytes and the level of soluble inflammatory mediators within the blister
| Estimated Enrollment: | 24 |
| Study Start Date: | January 2003 |
| Estimated Study Completion Date: | June 2005 |
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| Ages Eligible for Study: | 30 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| United Kingdom | |
| Hammersmith Hospital | |
| London, United Kingdom, W12 0NN | |
| Principal Investigator: | Kenneth M Taylor, MD, FRCS | Hammersmith Hospital Campus, Imperial College |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00131040 History of Changes |
| Other Study ID Numbers: | FS/03/065/15951 |
| Study First Received: | August 15, 2005 |
| Last Updated: | October 6, 2005 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by Imperial College London:
|
Cardiopulmonary Surgery leukocyte inflammation Coronary Artery Bypass Grafting |
Additional relevant MeSH terms:
|
Angina Pectoris Coronary Artery Disease Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Chest Pain Pain Signs and Symptoms Coronary Disease Arteriosclerosis Arterial Occlusive Diseases |
Aprotinin Trypsin Inhibitors Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Hemostatics Coagulants Hematologic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013