Remote Ischaemic Conditioning for Post-surgical Complications in Hip Fracture (RIC-FRACTURE)

Recruiting now · Not applicable

Conditions studied: Hip Fracture

In brief

Background Hip fracture affects 70,000 people in the United Kingdom (UK) and costs an estimated £1.1 billion per year to the National Health Service (NHS). Key clinical indicators, such as early surgical repair, have been shown to improve patient outcomes, however morbidity and mortality remain extremely high, reflecting the urgent need for novel therapies to enhance outcomes. Common complications include infection, cardiovascular events, falls and venous thromboembolism. Remote Ischaemic Conditioning (RIC) is a treatment whereby a blood pressure cuff is inflated around an arm or leg to above systolic pressures to occlude blood flow to the limb for short periods of time, that do not result in harm, but trigger innate mechanisms that reduce inflammation, improve organ blood flow and improve bone healing. These may be beneficial effects after hip fracture. Methods This is a single centre, feasibility study; the participants will receive RIC daily for 40 minutes for 10 days during their inpatient stay. Outcome measures relating primarily to safety, tolerability and feasibility will be collected along with compliance with the intervention. Study feasibility will be determined by success criteria based on recruitment, outcome measure assessment compliance with intervention and follow up. Secondary outcomes including inpatient mortality, inpatient complications, length of inpatient stay, blood pressure, serum inflammatory and stress markers and functional recovery will also be collected at discharge and 3 month follow up. Results Data collected on safety, tolerability, and feasibility will be presented descriptively and simple analysis of variance will be undertaken on quantitative data such as blood pressure and serum inflammatory and stress markers between baseline and follow up time points. The study will hopefully establish whether this therapy is feasible to deliver after acute hip fracture.

Key facts

Study ID

NCT07178041

Run by

Sheffield Teaching Hospitals NHS Foundation Trust

People needed

12

Starts

2024-08-02

Expected to finish

2025-12-31

Last updated by the study team

2025-09-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults (aged > 18 years)
• Participant has had a hip fracture identified on X-ray or computed tomography (CT) scan.
• Qualifying hip fracture has not occurred more than 7 days prior to enrollment.
• Able to give written informed consent.
• In the opinion of the treating physician would be able to conform to the study protocol and procedures.

You may not qualify if…

• History or presence of significant peripheral vascular disease in the limb conditioned.
• History or presence of complex neuropathic pains or peripheral neuropathy in the limb conditioned.
• Presence of lymphoedema in the limb conditioned.
• Presence of skin ulceration to the limb conditioned.
• Uncontrolled arrhythmia, hypertension, diabetes or angina.
• Third degree heart block or progressive heart failure.
• Acute aortic dissection, myocarditis, or pericarditis.
• Acute deep vein thrombosis, pulmonary embolism.
• Suspected or known dissecting aneurysm.
• Stroke or TIA myocardial infarction in the last 4 weeks.

Where it is running

• Sheffield Teaching Hospitals NHS Foundation Trust — Sheffield, South Yorkshire, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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