Bleeding in Partial Upper Hemisternotomy Versus Full Sternotomy Aortic Valve Replacement

• Sponsor: Karolinska University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02272621
• Collaborator: Karolinska Institutet (Other)
• Enrollment: 100
• Location: 1
• Arms: 2
• Actual Duration (Months): 83
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aortic Valve Stenosis; Heart Valve Diseases	Procedure: Minimally invasive aortic valve replacement; Procedure: Full sternotomy aortic valve replacement	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Actual Study Start Date: Nov 1, 2013
• Actual Primary Completion Date: Oct 1, 2020
• Actual Study Completion Date: Oct 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Partial upper hemisternotomy aortic valve replacement Partial upper hemisternotomy AVR will be performed according to current standard of care practices.	Procedure: Minimally invasive aortic valve replacement
Experimental: Full sternotomy aortic valve replacement Full sternotomy AVR through a standard median sternotomy will be performed according to current standard of care practices.	Procedure: Full sternotomy aortic valve replacement

Outcome Measures

Primary Outcome Measures

1. Universal definition of perioperative bleeding in adult cardiac surgery [Within 3 days from surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Cardiothoracic Surgery, Karolinska University Hospital	Stockholm		Sweden

Sponsors and Collaborators

• Karolinska University Hospital
• Karolinska Institutet

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Magnus Dalén, MD, PhD, Karolinska University Hospital
• ClinicalTrials.gov Identifier: NCT02272621
• Other Study ID Numbers: CMILE-bleeding
• First Posted: Oct 23, 2014
• Last Update Posted: Jun 2, 2021
• Last Verified: May 1, 2021

• Additional relevant MeSH terms: Aortic Valve Stenosis; Heart Valve Diseases

Study Results

No Results Posted as of Jun 2, 2021