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Heart surgery gas study pulled before starting

NCT ID NCT04022161

Knowledge-focused Sponsor: Massachusetts General Hospital Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study was designed to measure how breathing nitric oxide gas affects oxidation levels in the blood of heart surgery patients. It was an add-on to a larger trial and planned to enroll adults having elective heart surgery with a bypass machine. However, the study was withdrawn before any participants were enrolled, so no results are available.

What this could mean

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

Active substance
Nitric Oxide

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.

Started

Jul 2019

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 years and older

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: * Eligible and randomized in the trial NCT02836899 * Provide written informed consent * Age ≥ 18 years of age * Elective cardiac or aortic surgery with CPB \>90 minutes * Clinical evidence of endothelial dysfunction assessed by a specifically designed questionnaire Exclusion Criteria: * Estimated Glomerular Filtration Rate less than 30 ml/min/1.73 m2 * Emergent cardiac surgery * Life expectancy \< 1 year at the time of enrollment * Hemodynamic instability as defined by a systolic blood pressure \<90 mmHg. * Mean pulmonary artery pressure ≥ 40 mm Hg and PVR \> 4 Wood Units. * Left ventricular ejection fraction \< 30% by echocardiography obtained within three months of enrollment * Administration of one or more Packed Red Blood Cell (PRBC) transfusions in the week prior to enrollment * X-ray contrast infusion less than 48 hours before surgery * Evidence of hemolysis from any other origin: a. Intravascular: i. Intrinsic RBC defects leading to hemolytic anemia (eg, enzyme deficiencies, hemoglobinopathies, membrane defects) ii. Extrinsic: liver disease, hypersplenism, infections (eg, bartonella, babesia, malaria), treatment with oxidizing exogenous agents (eg, dapsone, nitrites, aniline dyes), exposure to other hemolytic agents (eg, lead, snake and spider bites), lymphocyte leukemia, autoimmune hemolytic disorders b. Extravascular: Infection (eg, clostridial sepsis, severe malaria), paroxysmal cold hemoglobinuria, cold agglutinin disease, paroxysmal nocturnal hemoglobinuria, iv infusion of Rho(D) immune globulin, iv infusion of hypotonic solutions

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder

As listed by the trial registrant

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

Cardiovascular diseases Endothelial dysfunction Oxidative stress

Contacts and locations

Locations

  • MP 825 Southampton General Hospita

    Southampton, Hampshire, SO16 6YD, United Kingdom

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

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