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Neurologic Injury Following Aortic Arch Replacement

NCT02750423 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2018-03-30

No results posted yet for this study

Summary

Investigators are seeking to learn how well different cooling temperatures along with different blood flow pathways to the brain reduce the risk of injury to the brain in participants planning to undergo elective aortic arch and hemiarch surgery. Participants will be randomized to receive a cerebral protection strategy of either: deep hypothermic circulatory arrest and retrograde cerebral perfusion (DHCA+RCP) or moderate hypothermic circulatory arrest and unilateral selective antegrade cerebral perfusion (MHCA+uSACP). Evidence of neurologic injury will be assessed with neurologic exams, neurocognitive tests, MRI imaging of the brain and measurement of plasma S-100 levels during post operative follow ups.

Conditions

  • Aortic Arch Replacement
  • Hemi 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.

Sponsors & Collaborators

  • Emory University

    lead OTHER

Principal Investigators

  • Bradley Leshnower, MD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02750423 on ClinicalTrials.gov