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NCT03111875 · ClinicalTrials.gov registry record · NA

Perioperative Hypothermia and Myocardial Injury After Non-cardiac Surgery

A NA study, sponsored by The Cleveland Clinic.

Completed
Registry status
NA
Development phase
5,056
Enrollment target

NCT03111875: Completed NA study, sponsored by The Cleveland Clinic.

NCT03111875 is a NA study that has completed, run by The Cleveland Clinic. The registered enrollment target is 5,056 participants, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (260% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03111875, a NA study, has completed, sponsored by The Cleveland Clinic.

COMPLETED
Registry status
NA
Development phase
5,056 participants
Enrollment target

Study Summary

We propose to test the hypothesis that aggressive warming reduces the incidence of major cardiovascular complications, compared to routine care. Half of the participants will be randomly assigned to routine care (core temperature ≈35.5°C), while the other half will receive aggressive warming (\>37°C core temperature) in a multi-center trial.

Primary Outcome

The primary outcome was a composite of myocardial injury after non-cardiac surgery, non-fatal cardiac arrest, and all-cause mortality within 30 days of surgery. Myocardial injury was diagnosed when available troponin concentrations exceeded generation-specific and type-specific thresholds and were apparently of ischaemic origin (ie, no other obvious cause for artifactual elevation). We used the following thresholds based on available literature at time of adjudication: 1) non-high-sensitivity (f

Interventions

  • DEVICE aggressive warming
  • DEVICE routine thermal management

Trial Details

FieldValue
Enrollment Target 5,056 participants
Start Date 2017-03-27
Est. Completion 2022-05-17
Phase NA
The Cleveland Clinic

688 total trials

What the finished NCT03111875 record still lists

NCT03111875 is an interventional study that assigns participants to a tested intervention. Its 5,056 participants enrollment target places it among the larger protocols in the corpus, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (260% higher).

The record links to 0 conditions, and to 2 interventions - of which aggressive warming is the first listed.

NCT03111875 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03111875 about?

NCT03111875 is a clinical study titled "Perioperative Hypothermia and Myocardial Injury After Non-cardiac Surgery". We propose to test the hypothesis that aggressive warming reduces the incidence of major cardiovascular complications, compared to routine care. Half of the participants will be randomly assigned to routine care (core temperature ≈35.5°C), while the other half will receive aggressive warming (\>37°C...

What is the current status of trial NCT03111875?

This trial is currently completed. It is a NA study. The enrollment target is 5,056 participants. The study started on 2017-03-27. Estimated completion is 2022-05-17.

What interventions are being tested in trial NCT03111875?

The interventions under investigation include: aggressive warming (DEVICE), routine thermal management (DEVICE).

Who is sponsoring clinical trial NCT03111875?

This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03111875's enrollment target sits among peer trials

5,056 25th of 2000 higher than 1,976 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 NCT03111875, the US trial registry maintained by the National Library of Medicine. NCT03111875 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.