NCT00131040

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2003

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2005

Completed
Last Updated

May 28, 2015

Status Verified

August 1, 2005

First QC Date

August 15, 2005

Last Update Submit

May 27, 2015

Conditions

Ischemic Heart DiseaseAngina Pectoris

Keywords

CardiopulmonarySurgeryleukocyteinflammationCoronary Artery Bypass Grafting

Outcome Measures

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

Interventions

AprotininDRUG

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary elective coronary artery bypass surgery

You may not qualify if:

  • Emergent, urgent or re-do surgery
  • Patients on oral corticosteroid medication
  • Patients on aspirin therapy \< 7 days prior to operation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hammersmith Hospital

London, W12 0NN, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 15248227BACKGROUND

  • 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.

    PMID: 14656926BACKGROUND

MeSH Terms

Conditions

Myocardial IschemiaAngina PectorisInflammation

Interventions

Aprotinin

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Intervention Hierarchy (Ancestors)

ProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Kenneth M Taylor, MD, FRCS

    Hammersmith Hospital Campus, Imperial College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 15, 2005

First Posted

August 17, 2005

Study Start

January 1, 2003

Study Completion

June 1, 2005

Last Updated

May 28, 2015

Record last verified: 2005-08

Locations

GB(1)