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ISRCTN
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ISRCTN28343638
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ClinicalTrials.gov identifier
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Public title
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Histamine Release and Implications of H1- and H2-Blockade in Adult Cardiac Surgery - A Randomised Controlled Study
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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Systemic inflammatory response is associated with cardiac surgery. Mediators liberated include cytokines and histamine. Histamine is associated with systemic effects like vasodilatation and cardiac dysrhythmias.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Cardiovascular disease
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Participants - inclusion criteria
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Entry criteria: Patients presenting for elective coronary artery bypass grafting (CABG) and valve surgeries using cardiopulmonary bypass.
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Participants - exclusion criteria
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1. Patients on heparin or nitrate infusions
2. Patients with known allergies
3. Known asthmatics and patients with severe chronic obstructive pulmonary disease (COPD)
4. Patients on steroids or other immunosuppressive drugs
5. Emergency procedures or re-do operations
6. Patients on regular H1 or H2 blockers
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Anticipated start date
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01/02/2005
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Anticipated end date
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01/01/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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80
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Interventions
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Patients will be randomly allocated into two groups.
Group H: this group will receive prophylactic H1- and H2-blockade
Group O: control group with no H1- and H2-blockade (placebo)
The study will be double blinded.
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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University of Wales College of Medicine (UWCM) Endowment Fund, UK
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Trial website
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Publications
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Contact name
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Dr
Cristina
Diaz-Navarro
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Address
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University Hospital of Wales
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City/town
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Cardiff
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Zip/Postcode
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CF4 4XW
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Country
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United Kingdom
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Tel
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+44 (0)2920743107
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Email
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Sponsor
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University of Wales College of Medicine, UK
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Address
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Heath Park
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City/town
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Cardiff
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Zip/Postcode
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CF4 4XW
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Country
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United Kingdom
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Email
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HumphreysJM@cf.ac.uk
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Date applied
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15/12/2004
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Last edited
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31/05/2011
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Date ISRCTN assigned
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31/01/2005
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