Autologous Transfusion In Surgery: a randomised clinical trial
| ISRCTN | ISRCTN85756518 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85756518 |
| Secondary identifying numbers | RHC18069 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 21/01/2010
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Charles McCollum
Scientific
Scientific
Academic Surgery Unit
2nd Floor ERC
University Hospital of South Manchester
Southmoor Road
Manchester
M23 9LT
United Kingdom
| Phone | +44 (0)161 291 5853 |
|---|---|
| cnmcc@manchester.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | ATIS |
| Study objectives | Does autologous transfusion reduce the use of homologous stored blood? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/10/1997 |
| Completion date | 01/10/1999 |
| Reason abandoned (if study stopped) | Lack of funding/sponsorship |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Not provided at time of registration |
| Key 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 |
| Key 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. |
| Date of first enrolment | 01/10/1997 |
| Date of final enrolment | 01/10/1999 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Academic Surgery Unit
Manchester
M23 9LT
United Kingdom
M23 9LT
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive North West (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
