Heart surgery gas study pulled before it began

NCT ID NCT03748082

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

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

Summary

This study was designed to test whether giving nitric oxide gas during heart surgery could help protect blood vessels in patients with pre-existing vessel problems. It was an add-on to a larger trial and planned to enroll adults having elective heart surgery with prolonged bypass. However, the study was withdrawn before any participants were enrolled, so no results are available.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

Dec 2018

Expected to finish

Nov 2023

An estimate. End dates often move.

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 Hemolysis

As listed by the trial registrant

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

Cardiovascular diseases Cardiovascular risk factor Endothelial dysfunction Hemolysis intravascular

Heart surgery gas study pulled before it began

What the study statuses mean