Condition category
Circulatory System
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
21/01/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.doh.gov.uk

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

Publication citations

Additional files

Editorial Notes