Manubrium-limited ministernotomy versus conventional sternotomy for aortic valve replacement

Manubrium-limited ministernotomy versus conventional sternotomy for Aortic Valve Replacement: a randomIsed Controlled trial (MAVRIC)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN29567910

Enrollment

220

Registered

2014-02-03

Start date

2014-02-01

Completion date

Unknown

Last updated

2021-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Manubrium-limited ministernotomy, conventional sternotomy, aortic valve replacement (AVR), red blood cell transfusion Circulatory System

Interventions

Patients will be randomised to receive Aortic Valve Replacement via Manubrium-Limited Ministernotomy (intervention arm) or Aortic Valve Replacement via Conventional Sternotomy (control arm).

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 18 years or older at the time of consent 2. Requiring first-time, non-emergency, isolated aortic valve replacement surgery 3. Able and willing to provide written informed consent

Exclusion criteria

Exclusion criteria: 1. Requiring concomitant cardiac procedure(s) 2. Haemoglobin level < 90g/L 3. Pregnant 4. Are unable to stop currently prescribed treatment affecting clotting 5. A history of thrombophilia, thrombocytopenia or other haematological conditions that would affect participation in the trial 6. Infective endocarditis 7. Prevented from having red blood cells and blood products according to a system of beliefs

Design outcomes

Primary

Measure	Time frame
The proportion of patients who receive a red blood cell transfusion post-operatively within 7 days of AVR surgery	—

Secondary

Measure	Time frame
1. The proportion of patients who receive a red blood cell transfusion during the intra-operative period, post-operative period (from admission to CICU to 7 days) 2. The number of red blood cell transfusion units per patient within the 7 days following AVR surgery 3. The proportion of patients receiving platelet transfusion or receiving fresh frozen plasma transfusion within the 7 days following AVR surgery 4. The total number of patients receiving any blood products and the number of units transfused within the 7 days following AVR surgery and during the entire hospital stay 5. The average and range of postoperative blood loss within 6 and 12 hours after surgery 6. Re-operation rates following the end of index surgery 7. Quality of life EuroQol (EQ-5D-3L, EQ-VAS) measured at baseline, day 2, 6 weeks and 12 weeks 8. The average day and range of days upon which patients are deemed ?fit for discharge? from hospital 9. Health care utilisation to 12 weeks post-surgery 10. Cost and cost effectiveness 11. Adverse event profiles related to study procedures for each arm	—

Measure

Time frame

1. The proportion of patients who receive a red blood cell transfusion during the intra-operative period, post-operative period (from admission to CICU to 7 days) 2. The number of red blood cell transfusion units per patient within the 7 days following AVR surgery 3. The proportion of patients receiving platelet transfusion or receiving fresh frozen plasma transfusion within the 7 days following AVR surgery 4. The total number of patients receiving any blood products and the number of units transfused within the 7 days following AVR surgery and during the entire hospital stay 5. The average and range of postoperative blood loss within 6 and 12 hours after surgery 6. Re-operation rates following the end of index surgery 7. Quality of life EuroQol (EQ-5D-3L, EQ-VAS) measured at baseline, day 2, 6 weeks and 12 weeks 8. The average day and range of days upon which patients are deemed ?fit for discharge? from hospital 9. Health care utilisation to 12 weeks post-surgery 10. Cost and cost effectiveness 11. Adverse event profiles related to study procedures for each arm

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 11, 2026