Condition category
Surgery
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
29/01/2015
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

Mr Unnikrishnan Nair

ORCID ID

Contact details

Cardiothoracic Surgery Department
Yorkshire Heart Centre
D Floor
Jubilee Building
Great George Street
Leeds
LS1 3EX
United Kingdom
+44 (0)113 392 5792
abc@email.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0436176306

Study information

Scientific title

Internal mammary artery harvest with papaverine vs saline infiltration

Acronym

Study hypothesis

To see whether infiltrating papaverine into endothoracic fascia while harvesting compared to saline as reported in literature makes any difference in terms of spasm, size and flow difference in the mammary conduit.

Ethics approval

Leeds East Ethics Committee, ref 05/Q1206/185

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Surgery: Coronary artery bypass graft (CABG)

Intervention

Internal thoracic artery (IMA) harvest with papaverine vs normal saline infiltration into endothoracic fascia

Intervention type

Drug

Phase

Not Applicable

Drug names

Papaverine

Primary outcome measures

To see the difference in quality of mammary artery conduit with two different methods of harvesting (quality of the mammary artery that includes the spasm, flow and appearances).

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/02/2006

Overall trial end date

01/07/2008

Reason abandoned

Eligibility

Participant inclusion criteria

All patients having coronary artery bypass surgery where artery behind the breast bone is used will be invited to take part.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50 with 25 in each group

Participant exclusion criteria

1. Patients not willing to participate
2. Internal Mammary Artery (IMA) not used

Recruitment start date

01/02/2006

Recruitment end date

01/07/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Leeds General Infirmary
Leeds
LS1 3EX
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

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.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Leeds Teaching Hospitals NHS Trust (UK), NHS R&D Support Funding

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