Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
16/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr H Pauli

ORCID ID

Contact details

Department of Anaesthesia
Leeds General Infirmary
Leeds
LS1 3EX
United Kingdom
+44 (0)113 392 6672

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0436117978

Study information

Scientific title

Acronym

Study hypothesis

We propose to assess and compare the coupling of cerebral metabolism and cerebral blood flow in patients undergoing coronary artery bypass grafting using moderate hypothermic cardiopulmonary bypass primed with retrograde autologous or conventional priming.

Ethics approval

Not provided at time of registration

Study design

Randomised active controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Coronary artery bypass grafting (CABG)

Intervention

Randomised controlled trial. Random allocation to:
1. Conventional priming of cardiopulmonary bypass circuit
2. Retrograde autologous priming of bypass circuit

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

To compare SjvO2 values immediately after establishing full cardiopulmonary bypass pump flow.

Secondary outcome measures

Further SjvO2 values and Lactate - Oxygen Indices.

Overall trial start date

31/08/2002

Overall trial end date

31/08/2003

Reason abandoned

Eligibility

Participant inclusion criteria

20 Patients scheduled to undergo first time coronary artery bypass grafting will be recruited. They will be American Society of Anaesthesiologist grade III or less.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

Participant exclusion criteria

1. History of cerebrovascular disease
2. Diabetes mellitus
3. Body weight less than 60 kg
4. Haemoglobin level of less than 11g/dl
5. Refusal to receive blood products

Recruitment start date

31/08/2002

Recruitment end date

31/08/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Anaesthesia
Leeds
LS1 3EX
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Funder name

Leeds Teaching Hospitals 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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes