Neurologic Injury Following Aortic Arch Replacement

NACompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

April 30, 2016

Primary Completion Date

December 31, 2017

Study Completion Date

December 31, 2017

Conditions
Aortic Arch ReplacementHemi Arch Replacement
Interventions
PROCEDURE

DHCA+RCP

During deep hypothermic circulatory arrest and retrograde cerebral perfusion (DHCA+RCP) the participant is placed on cardiopulmonary bypass (heart-lung machine) and their body temperature is lowered to a range of 14-18 °C. Once the goal temperature has been achieved, the circulation is stopped and aortic arch replacement is performed in a bloodless surgical field. Blood will be pushed to the brain through arterial vessels, much like the natural blood flow pattern. Once the aortic arch repair is complete, cardiopulmonary bypass is reinstituted, the participant is rewarmed, and separated from cardiopulmonary bypass.

PROCEDURE

MHCA + SACP

During moderate hypothermic circulatory arrest and unilateral selective antegrade cerebral perfusion (MHCA + SACP) the participant is placed on cardiopulmonary bypass (heart-lung machine0 and the native blood flow to the brain is temporarily suspended. The body is cooled to temperatures of ≤28°C and blood is administered to the brain via an artery in the neck during the period of arch reconstruction. Once the aortic arch repair is complete, cardiopulmonary bypass is reinstituted, the participant is rewarmed, and separated from cardiopulmonary bypass.

Trial Locations (2)

30322

Emory University Hospital, Atlanta

30342

Emory Saint Joseph's Hospital, Atlanta

All Listed Sponsors
lead

Emory University

OTHER

NCT02750423 - Neurologic Injury Following Aortic Arch Replacement | Biotech Hunter | Biotech Hunter