Actively Recruiting
The ALOFT Pilot Trial
Led by Ottawa Hospital Research Institute · Updated on 2024-04-04
90
Participants Needed
1
Research Sites
144 weeks
Total Duration
On this page
Sponsors
O
Ottawa Hospital Research Institute
Lead Sponsor
C
Canadian Institutes of Health Research (CIHR)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The ALOFT Pilot Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Scheduled for lower limb revascularization surgery, including infrainguinal arterial bypass, femoral endarterectomy, or patch angioplasty (elective or urgent)
- Able to use a telephone for postoperative follow-up
You will not qualify if you...
- Absolute contraindications to neuraxial anesthesia, including impaired blood clotting, infection at needle site, increased intracranial pressure or mass, uncorrected low blood pressure, or severe aortic stenosis
- Surgery due to traumatic arterial injuries
- Multiple sclerosis or other demyelinating central nervous system disorders
- Known malignant hyperthermia or need for trigger-free anesthetic
- Pregnancy
- Previous enrollment in this study or participation in another interfering interventional trial unless agreed upon in writing
- Considered unsuitable for randomization by surgeon, anesthesiologist, or other clinician
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
Research Team
E
Emily Hladkowicz, PhD (c)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here