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Can Ice-Cold saline save trauma victims in cardiac arrest?

NCT ID NCT01042015

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a dramatic approach: rapidly cooling trauma patients whose hearts had stopped from severe bleeding. Doctors flushed ice-cold saline into the aorta to induce deep hypothermia, then performed emergency surgery to stop the bleeding before slowly rewarming the patient. The goal was to see if this could help patients survive without major brain damage. Only 20 people were enrolled before the trial was stopped early.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ice-cold saline flush into the aorta
What this could lead to
If it works, this could provide a way to temporarily preserve trauma patients in cardiac arrest, buying time for surgeons to control bleeding and potentially improve survival without severe disability.
What could go wrong
This was a very small, early-phase trial that was terminated, so results are limited. The procedure is highly invasive and carries risks like organ damage from extreme cooling or complications from cardiopulmonary bypass.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2016

Finished

Nov 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Penetrating trauma with clinical suspicion of exsanguinating hemorrhage * At least 1 sign of life at the scene (pulse, respiratory efforts, spontaneous movements, reactive pupils) * Loss of pulse \<5 min prior to Emergency Department (ED) arrival or in ED or operating room * ED thoracotomy performed without immediate return of a palpable pulse in the carotid arteries after clamping the descending thoracic aorta Exclusion Criteria: * No signs of life for \>5 min prior to the decision to initiate EPR * Obvious non-survivable injury * Suggestion of traumatic brain injury, such as significant facial or cranial distortion * Electrical asystole * Rapid external assessment of the injuries suggests massive tissue trauma or blunt trauma involving multiple body regions * Pregnancy * Prisoners

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Conditions

The condition(s) this trial relates to.

cardiac arrest injury Shock, Hemorrhagic

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • University of Maryland

    Baltimore, Maryland, 21201, United States