Contact information
Type
Scientific
Primary contact
Prof Charles McCollum
ORCID ID
Contact details
Academic Surgery Unit
2nd Floor ERC
University Hospital of South Manchester
Southmoor Road
Manchester
M23 9LT
United Kingdom
+44 (0)161 291 5853
cnmcc@manchester.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RHC18069
Study information
Scientific title
Acronym
ATIS
Study hypothesis
Does autologous transfusion reduce the use of homologous stored blood?
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
Treatment
Patient information sheet
Condition
Cardiovascular diseases: Peripheral arterial disease
Intervention
1. Autologous transfusion: acute normovolaemic haemodilution and intragerative cell salvage
2. Homologous transfusion: homologous blood if required
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Blood transfusion requirements, haematological and haemostatic parameter, post-operative infection, morbidity and hospital stay, economic analysis
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/10/1997
Overall trial end date
01/10/1999
Reason abandoned
Lack of funding/sponsorship
Eligibility
Participant inclusion criteria
All patients undergoing elective surgery for either occlusive or aneurysmal arterial disease will be asked to give written informed consent:
1. Both men and women aged 30-85
2. Considered fit for aortic surgery without any of the exclusion criteria
3. Pre-operative haemoglobin >11 g/dl and platelet count >150 x 10^9/1
4. Adequate cardiac and pulmonary function clinically
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Any patient unfit for aortic surgery, unable for any reason to receive either autologous or standard transfusion therapy, or undergoing emergency surgery for suspected rupture of an aneurysm.
Recruitment start date
01/10/1997
Recruitment end date
01/10/1999
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Academic Surgery Unit
Manchester
M23 9LT
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
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
NHS Executive North West (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