Internal mammary artery harvest with papaverine vs saline infiltration

ISRCTN	ISRCTN62199147
DOI	https://doi.org/10.1186/ISRCTN62199147
Secondary identifying numbers	N0436176306

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

Mr Unnikrishnan Nair
Scientific

Cardiothoracic Surgery Department
Yorkshire Heart Centre, D Floor
Jubilee Building
Great George Street
Leeds
LS1 3EX
United Kingdom

Phone	+44 (0)113 392 5792
Email	abc@email.com

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Internal mammary artery harvest with papaverine vs saline infiltration
Study objectives	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(s)	Leeds East Ethics Committee, ref 05/Q1206/185
Health condition(s) or problem(s) studied	Surgery: Coronary artery bypass graft (CABG)
Intervention	Internal thoracic artery (IMA) harvest with papaverine vs normal saline infiltration into endothoracic fascia
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Papaverine
Primary outcome measure	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 study start date	01/02/2006
Completion date	01/07/2008

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	50 with 25 in each group
Key inclusion criteria	All patients having coronary artery bypass surgery where artery behind the breast bone is used will be invited to take part.
Key exclusion criteria	1. Patients not willing to participate 2. Internal Mammary Artery (IMA) not used
Date of first enrolment	01/02/2006
Date of final enrolment	01/07/2008

Leeds General Infirmary

Leeds
LS1 3EX
United Kingdom

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

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Government

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

No information available

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