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Compares treatment options for Thoracic Aortic Disease
Official title Comparing Hypothermic Temperatures During Hemiarch Surgery
ClinicalTrials.gov ID: NCT02860364
What this study is testing
- What it's testing
- Hypothermic circulatory arrest is an important surgical technique, allowing complex aortic surgeries to be performed safely. Hypothermic circulatory arrest provides protection to cerebral and visceral organs, but may result in longer cardiopulmonary bypass times during surgery, increased risks of bleeding, inflammation, and neuronal injury.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years
- Elective aortic hemiarch surgery
- Planned unilateral selective anterograde cardioplegia
- Anticipated lower body arrest time of \< 20 minutes
- Able to provide written informed consent
You likely can't join if
- Surgery for acute aortic dissection or emergent operations
- Total arch replacement
- Inability to perform unilateral selective anterograde cerebral perfusion (uSACP)
- Patients with known/documented coagulopathy
- Patients with cold agglutinin disease or those that test positive on routine preop screening
- Pre-existing severe neurological impairment or inability to accurately assess neurocognitive function as determined by the operating surgeon
See the full eligibility criteria
- Age ≥ 18 years
- Elective aortic hemiarch surgery
- Planned unilateral selective anterograde cardioplegia
- Anticipated lower body arrest time of \< 20 minutes
- Able to provide written informed consent
- Surgery for acute aortic dissection or emergent operations
- Total arch replacement
- Inability to perform unilateral selective anterograde cerebral perfusion (uSACP)
- Patients with known/documented coagulopathy
- Patients with cold agglutinin disease or those that test positive on routine preop screening
- Pre-existing severe neurological impairment or inability to accurately assess neurocognitive function as determined by the operating surgeon
- Severe carotid disease, defined as: any patient with previously documented carotid stenosis of \> 70% (via Doppler ultrasound (US), magnetic resonance angiography (MRA), or computer tomography angiography (CTA)) without...
- Patients in renal failure or currently being treated with renal replacement therapy (RRT) or estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73m2
- Use of an investigational drug or device at time of enrollment
- Participation in another clinical trial which interferes with performance of the study procedures or assessment of the outcomes
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- Ridgewood, New Jersey, United States
- Columbus, Ohio, United States
- Kelowna, British Columbia, Canada
- Surrey, British Columbia, Canada
- Vancouver, British Columbia, Canada
- Halifax, Nova Scotia, Canada
- London, Ontario, Canada
- Ottawa, Ontario, Canada
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Québec, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States; Ridgewood, New Jersey, United States; Columbus, Ohio, United States; Kelowna, British Columbia, Canada; Surrey, British Columbia, Canada; Vancouver, British Columbia, Canada and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.