The role and modulation of the adaptive immune response in human limb ischaemia reperfusion injury by ischaemic preconditioning

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN66931248

Enrollment

Registered

2008-08-28

Start date

2006-07-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Reperfusion injury Surgery Surgical operation and other surgical procedures as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
No secondary outcome measures	—

Countries

Ireland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026