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NCT02834065 · ClinicalTrials.gov registry record · NA

Cognitive Effects of Body Temperature During Hypothermic Circulatory Arrest

A NA study, sponsored by Duke University.

Completed
Registry status
NA
Development phase
273
Enrollment target

NCT02834065: Completed NA study, sponsored by Duke University.

NCT02834065 is a NA study that has completed, run by Duke University. The registered enrollment target is 273 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02834065, a NA study, has completed, sponsored by Duke University.

COMPLETED
Registry status
NA
Development phase
273 participants
Enrollment target

Study Summary

In this study the investigator will randomize 273 subjects to deep (\<20°C), low (20.1°C-24°C), or moderate (24.1°C-28°C) hypothermia during aortic arch surgery with circulatory arrest. The primary purpose of this study is to determine the effect of deep vs low vs moderate hypothermia on neurocognitive function, brain functional connectivity, and leukocyte SUMOylation patterns after surgical circulatory arrest in participants.

Primary Outcome

To characterize cognitive function over time while minimizing potential redundancy in the cognitive measures, a factor analysis will be performed on the cognitive test scores from baseline. A continuous change score will be calculated by subtracting the baseline cognitive index (the mean of the domain scores from factor analysis) from the follow-up cognitive index at 4 weeks.

Interventions

  • DEVICE Cardiopulmonary bypass machine

Trial Details

FieldValue
Enrollment Target 273 participants
Start Date 2016-07-28
Est. Completion 2023-02
Phase NA
Duke University

1,725 total trials

What the finished NCT02834065 record still lists

NCT02834065 is an interventional study that assigns participants to a tested intervention. The registered 273 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (81% lower).

The record links to 0 conditions, and to 1 intervention - of which Cardiopulmonary bypass machine is the first listed.

NCT02834065 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02834065 about?

NCT02834065 is a clinical study titled "Cognitive Effects of Body Temperature During Hypothermic Circulatory Arrest". In this study the investigator will randomize 273 subjects to deep (\<20°C), low (20.1°C-24°C), or moderate (24.1°C-28°C) hypothermia during aortic arch surgery with circulatory arrest. The primary purpose of this study is to determine the effect of deep vs low vs moderate hypothermia on neurocognit...

What is the current status of trial NCT02834065?

This trial is currently completed. It is a NA study. The enrollment target is 273 participants. The study started on 2016-07-28. Estimated completion is 2023-02.

What interventions are being tested in trial NCT02834065?

The interventions under investigation include: Cardiopulmonary bypass machine (DEVICE).

Who is sponsoring clinical trial NCT02834065?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02834065's enrollment target sits among peer trials

273 386th of 2000 higher than 1,614 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02834065, the US trial registry maintained by the National Library of Medicine. NCT02834065 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.