ClinicalTrials.gg
CompletedNCT00131040Updated May 28, 2015

Investigation of Leukocyte Trafficking Into Skin Blisters During Cardiopulmonary Bypass

An interventional study of Aprotinin in Ischemic Heart Disease and Angina Pectoris, sponsored by Imperial College London. Completed at 1 site in United Kingdom. Open to participants aged 30 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-05-28.

Primary conditionAngina PectorisRegistry: Myocardial IschemiaReclassifiedWhy we changed it
Registry
Myocardial Ischemia — the first condition term the registry derived for this study.
ClinicalTrials.gg
Angina Pectoris
Why
  1. The study's listed conditions name Angina Pectoris, a narrower term within Myocardial Ischemia.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Imperial College London · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
30 Years to 75 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Ischemic Heart Disease
  • Angina Pectoris

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Keywords

  • Cardiopulmonary
  • Surgery
  • leukocyte
  • inflammation
  • Coronary Artery Bypass Grafting
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In context

Angina Pectoris Reclassified

453 studies on the registry are indexed under Angina Pectoris; 67 are open to participants now.

This study's enrollment of 24 is below the median of 100 across 273 interventional studies indexed under Angina Pectoris.

Browse Angina Pectoris studies →

Lead sponsor

Imperial College London is the lead sponsor of 843 studies on the registry; 180 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.

Compared within Angina Pectoris, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Myocardial Ischemia. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
30 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Primary elective coronary artery bypass surgery

Exclusion criteria

Exclusion Criteria:

  • Emergent, urgent or re-do surgery
  • Patients on oral medication
  • Patients on aspirin therapy \< 7 days prior to operation
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
24 participants

Interventions

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What researchers measure

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

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Study locations

1 site
  • Hammersmith Hospital
    London, W12 0NN, United Kingdom
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References and documents

Publications

  • 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. PubMed 15248227 ↗
  • 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. PubMed 14656926 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 28, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00131040
Collaborators
British Heart Foundation
First posted
Aug 17, 2005
Start date
Jan 2003
Completion
Jun 2005
Last update
May 28, 2015

Study contacts

Kenneth M Taylor, MD, FRCS
principal investigator · Hammersmith Hospital Campus, Imperial College
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2005. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Aprotinin

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