Contact information
Type
Scientific
Primary contact
Mr R Fearn
ORCID ID
Contact details
Obstetric Anaesthesia
Gledhow Wing
Leeds Teaching Hospitals NHS Trust
Beckett Street
Leeds
LS9 7TF
United Kingdom
+44 (0)113 243 3144
r&d@leedsth.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0436130424
Study information
Scientific title
Acute effects of smoking and oral nicotine on blood haemostatis using thromboelastography
Acronym
Study hypothesis
1. To determine the acute effects of smoking on whole blood coagulation
2. To determine the acute effects of inhaled nicotine on whole blood coagulation
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Condition
Haemostasis
Intervention
Randomised controlled trial:
1. Smoking a cigarette versus smoking a sham cigarette
2. Inhaling from a nicotine inhaler versus inhaler from a inhaler with no nicotine
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Thromboelastography variables:
1. R-value
2. K-value
3. Angle
4. Maximum amplitude
5. Coagulation index
Secondary outcome measures
Not provided at time of registration
Overall trial start date
30/09/2002
Overall trial end date
30/07/2003
Reason abandoned
Eligibility
Participant inclusion criteria
Healthy adult smokers who fall into American Society of Anaesthesiologists classes 1 and 2
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
30/09/2002
Recruitment end date
30/07/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Obstetric Anaesthesia
Leeds
LS9 7TF
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Leeds Teaching Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary