Condition category
Surgery
Date applied
09/08/2008
Date assigned
28/08/2008
Last edited
28/08/2008
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

Prof Michael Kerin

ORCID ID

Contact details

Department of Surgery
Clinical Science Institute
Newcastle Road
National University of Ireland Galway
Galway
-
Ireland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

That local ischaemic preconditioning will alter bedside physiological parameters and systemic T cell activation, cytokine production and release in otherwise healthy patients undergoing lower limb surgery under tourniquet control.

Ethics approval

Clinical Research Ethical Committee at University College Hospital Galway. Date of approval: 15/12/2005 (ref: 48/05)

Study design

Prospective, single-centre, randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Condition

Reperfusion injury

Intervention

Consecutive patients undergoing anterior cruciate ligament repair were randomised to surgery alone or surgery preceded by three 5 minute cycles of local ischaemic preconditioning to the operative limb within 1 hour of surgery. Surgery to include 1 hour of limb ischaemia. An operative tourniquet was placed on the upper thigh and the limb was exsanguinated using a Rhys Davies air sleeve. Tourniquet pressure was set at 100 mmHg above systolic brachial blood pressure. Ischaemia was verified by arterial doppler distal to the tourniquet. Systemic venous blood was collected on admission, at 4 and 24 hours post reperfusion (post-operatively).

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

1. Change in perioperative systemic mean arterial pressure and heart rate
2. Alterations in systemic T cell subsets as evaluated by flow cytometry, assessed on the systemic venous blood collected on admission, at 4 and 24 hours post reperfusion (post-operatively)
3. Alterations in systemic cytokine levels (Interleukin-2 [IL2] and interferon, gamma [IFNg]), assessed on the systemic venous blood collected on admission, at 4 and 24 hours post reperfusion (post-operatively)
4. Co-culture production of IL-2, IL-4, IL-10 and IFNg, assessed using the samples taken from patients 4 hours post reperfusion. Controls were taken from healthy volunteers.
5. Co-culture alteration in T cell subsets, assessed using the samples taken from patients 4 hours post reperfusion. Controls were taken from healthy volunteers.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/07/2006

Overall trial end date

30/06/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Patients (both males and females) diagnosed with anterior cruciate ligament rupture by magnetic resonance imaging (MRI) or arthroscopy and undergoing patellar tendon graft reconstruction under tourniquet control.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

25

Participant exclusion criteria

1. Age under 18 or over 45
2. Having smoked in the preceding 3 months
3. Diagnosis of systemic auto-immune condition (e.g., thyroxicosis, inflammatory bowel/ coeliac disease, rheumatoid arthritis, systemic lupus erythematosus [SLE])
4. Diabetes
5. Concurrent medical condition
6. Pregnancy
7. Medications other than simple analgesics and non-steroidal anti-inflammatory drugs (NSAID)

Recruitment start date

01/07/2006

Recruitment end date

30/06/2007

Locations

Countries of recruitment

Ireland

Trial participating centre

Department of Surgery
Galway
-
Ireland

Sponsor information

Organisation

National University of Ireland Galway (Ireland)

Sponsor details

c/o Prof Michael Kerin
University College Hospital
Department of Surgery
Clinical Science Institute
Galway
-
Ireland

Sponsor type

University/education

Website

http://www.nuigalway.ie/surgery

Funders

Funder type

University/education

Funder name

National University of Ireland Galway, Department of Surgery (Ireland)

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