Off-pump Versus On-pump Coronary Artery Bypass Grafting in Frail Patients

NAActive, not recruitingINTERVENTIONAL
Enrollment

440

Participants

Timeline

Start Date

January 1, 2019

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2025

Conditions
Frail ElderlyCoronary Artery Disease
Interventions
OTHER

Off-pump coronary-artery bypass grafting

Surgical access to the heart will be gained through a median sternotomy in all of the patients. In order to reduce the risk of bleeding and transfusions, an absorbable hemostat will be used in the sternal bone marrow. An automatic autotransfusion system will be used to recovery of red blood cells in all patients. Off-pump surgery will be performed with the use of heart stabilizers. Patients will be heparinized with 250 IU/kg intravenously to achieve activated clotting time \>200s. The proximal anastomosis will be performed according to our guidelines. The distal anastomosis will be constructed with the help of mechanical stabilizers and cardiac positioner. Intracoronary shunts will be used routinely.

OTHER

On-pump coronary-artery bypass grafting

Surgical access to the heart will be gained through a median sternotomy in all of the patients. On-pump surgery will be performed in normothermia, with the use of aortic cross-clamping and cold cardioplegic arrest. Patients will be heparinized with 500 IU/kg to achieve an activated clotting time \>480 s. Heparin will be neutralized with 1:1 protamine sulfate. The automatic autotransfusion system will be used just in massive blood loss to recovery the red blood cells. Surgical techniques will be performed according to our guidelines.

Trial Locations (7)

30322

Emory University School of Medicine, Atlanta

Unknown

Hospital de Messejana, Fortaleza

37550-000

Hospital das Clínicas Samuel Libânio, Pouso Alegre

58040-300

Hospital Alberto Urquiza Wanderley, João Pessoa

22240-002

Instituto Nacional de Cardiologia de Laranjeiras, Rio de Janeiro

01323-001

Beneficência Portuguesa de São Paulo, São Paulo

05403-900

Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina de São Paulo, São Paulo

All Listed Sponsors
collaborator

Beneficência Portuguesa de São Paulo

OTHER

collaborator

Instituto Nacional de Cardiologia de Laranjeiras

OTHER

collaborator

Clinical Hospital Samuel Libânio of Pouso Alegre

UNKNOWN

collaborator

Hospital do Coração de Messejana Dr. Carlos Alberto Studart

UNKNOWN

lead

University of Sao Paulo General Hospital

OTHER