Bleeding in Partial Upper Hemisternotomy Versus Full Sternotomy Aortic Valve Replacement
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Universal definition of perioperative bleeding in adult cardiac surgery
Study Overview
Brief Summary
This is a single-center, open-label, randomized controlled trial. Patients scheduled for aortic valve replacement (AVR) at Karolinska University Hospital in Stockholm, Sweden will be eligible. One-hundred patients will be randomly assigned to either partial upper sternotomy (50 patients) or full sternotomy AVR (50 patients). Inclusion criteria is severe aortic stenosis referred for medically indicated isolated aortic valve replacement. Exclusion criteria are inclusion in other trial, left ventricular ejection fraction less than 0.45, previous cardiac surgery, or urgent/emergent surgery.
Mechanical and bioprosthetic (stented or sutureless) aortic valves will be implanted. Clinical characteristics will be registered. Clinical postoperative outcomes including bleeding outcomes will be registered. Routine blood sampling will be performed pre- and postoperatively. All available data will be collected prospectively. Informed consent will be obtained from patients meeting the inclusion criteria before the initiation of any study-specific procedures.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •≥ 18 years of age
- •Severe aortic stenosis defined as aortic valve area of less than 1 cm2 or index area of 0.6 cm2/m2 by echocardiography
- •Referred for medically indicated aortic valve replacement
- •Sinus rhythm
- •Provide written informed consent
Exclusion Criteria
- •Inclusion in other trial
- •Left ventricular ejection fraction less than 0.45
- •Presence of any coexisting severe valvular disorder
- •Previous cardiac surgery
- •Urgent or emergent surgery
Outcomes
Primary Outcomes
Universal definition of perioperative bleeding in adult cardiac surgery
Time Frame: Within 3 days from surgery
Secondary Outcomes
No secondary outcomes reported
Investigators
Magnus Dalén
MD, PhD
Karolinska University Hospital