The ALOFT Pilot Trial

Recruiting now · Not applicable

Conditions studied: Vascular Diseases, Peripheral Artery Disease, Surgery

In brief

The ALOFT Pilot Trial will evaluate three pragmatic elements (recruitment, adherence, and follow-up) of neuraxial versus general anesthesia for lower limb revascularization surgery that are necessary to support a successful, large-scale evaluation. We will concurrently use implementation science methodology to further refine processes for the larger trial. The future full ALOFT trial will be designed to evaluate the comparative effectiveness of two different anesthesia types for improving outcomes.

Key facts

Study ID

NCT06067789

Run by

Ottawa Hospital Research Institute

People needed

90

Starts

2024-03-25

Expected to finish

2027-01-01

Last updated by the study team

2024-04-04

Who can join

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

You may qualify if…

• Age ≥18 years
• Planned lower limb revascularization surgical procedure (on an elective or urgent basis): infrainguinal arterial bypass, femoral endarterectomy, patch angioplasty
• Able to access a telephone for postoperative follow-up

You may not qualify if…

• Absolute contraindications to neuraxial anesthesia: impaired coagulation state (due to intrinsic, congenital or extrinsic (i.e., anticoagulant not held for guideline recommended period based on the American Society of Regional Anesthesia recommendations) factors), infection at the needle insertion point, increased intracranial pressure or intracranial mass, uncorrected hypovolemia or hypotension (systolic blood pressure <90 mmHg), severe uncorrected aortic stenosis)
• Traumatic arterial injuries as an indication for surgery
• Multiple sclerosis or demyelinating central nervous system conditions
• Known malignant hyperthermia or who require a malignant hyperthermia trigger-free anesthetic
• Pregnancy
• Prior enrollment in this study, or participating in another interventional trial that could interfere with interpretation of data for either study (may be acceptable if unrelated interventions/outcomes and study PIs mutually agree in writing to co-enrollment)
• Determination by the surgeon, anesthesiologist, or other clinician, that the patient would not be suitable for randomization

Where it is running

• The Ottawa Hospital — Ottawa, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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