Autologous Transfusion In Surgery: a randomised clinical trial
| ISRCTN | ISRCTN85756518 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85756518 |
| Protocol serial number | RHC18069 |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive North West (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Blood transfusion requirements, haematological and haemostatic parameter, post-operative infection, morbidity and hospital stay, economic analysis |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/10/1999 |
| Reason abandoned (if study stopped) | Lack of funding/sponsorship |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| 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
- United Kingdom
- England
Study participating centre
Academic Surgery Unit
Manchester
M23 9LT
United Kingdom
M23 9LT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
