Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N0265041838
Study information
Scientific title
Acronym
Study hypothesis
Our hypothesis is that by using intraoperative swabs soaked in an adrenaline solution we will decrease surgical blood loss and hence decrease the need for postoperative and intraoperative blood transfusion.
Ethics approval(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Not Specified
Patient information sheet
Condition
Surgery: Hip fracture
Intervention
Randomly allocated to two groups (32 patients per group):
Group A: Wound site infiltrated with 10mls 0.5% marcain with adrenaline.
Group B: All swabs used intraoperatively soaked in a solution made up of 5 mg of adrenaline in 1 litre N/Saline.
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
Adrenaline
Primary outcome measure
Measured reduction in postoperative and interoperative blood loss.
Secondary outcome measures
Not provided at time of registration
Overall study start date
01/01/2004
Overall study end date
01/01/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients with fracture of the proximal femur requiring Dynamic Hip Screw fixation.
Participant type(s)
Patient
Age group
Not Specified
Sex
Not Specified
Target number of participants
64
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/2004
Recruitment end date
01/01/2007
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Trauma
Birmingham
B29 6JD
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
University Hospital Birmingham 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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|