NCT04003116

Brief Summary

The primary objective is to evaluate the efficacy of the treatment with supplementary oxygen added to conventional anticoagulant treatment in patients with Intermediate-risk pulmonary embolism. The secondary objective is to evaluate the safety of the treatment with supplementary oxygen added to conventional anticoagulant treatment in patients with Intermediate-risk pulmonary embolism.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2019

Typical duration for phase_3

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 1, 2019

Completed
10 days until next milestone

Study Start

First participant enrolled

July 11, 2019

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2022

Completed
Last Updated

August 18, 2022

Status Verified

August 1, 2022

Enrollment Period

2.8 years

First QC Date

June 27, 2019

Last Update Submit

August 17, 2022

Conditions

Pulmonary Embolism

Outcome Measures

Primary Outcomes (1)

  • Normal right ventricle function at 48 hours

    Right ventricle (RV) to left ventricle (LV) diameter ratio equal or less than 1.0 measured 48 hours after initiation of therapy in normotensive patients with intermediate-risk pulmonary embolism (PE).

    48 hours

Secondary Outcomes (1)

  • Modification RV -LV 7 days

    7 days

Study Arms (2)

Supplementary oxygen

EXPERIMENTAL

Supplementary oxygen added to conventional anticoagulant treatment.

Drug: Oxygen gas

Standard medical therapy

NO INTERVENTION

Standard management.

Interventions

Oxygen gasDRUG

Supplementary oxygen during the first 48 hours added to conventional anticoagulant treatment. Patients will receive anticoagulant treatment according to updated guidelines.

Supplementary oxygen

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed PE by multidetector computed tomographic pulmonary angiography (MDCT).
  • Disfunction of right ventricle (RV to left ventricle \[LV\] diameter ratio \>1.0 in the apical 4-chamber view) in the echocardiogram performed in the first 12 hours after PE diagnosis.
  • Signed and dated informed consent of the subject.

You may not qualify if:

  • \<18 years old.
  • Allergy to iodinated contrast.
  • Renal failure defined as a creatinine clearance less than 30 mL/min, according to the Cockcroft-Gault formula.
  • Use of chronic oxygen therapy.
  • Hypercapnia (pCO2 \>50 mmHg at the time of diagnosis).
  • Technically inadequate basal echocardiography.
  • Contraindication to anticoagulant therapy.
  • Symptoms duration \>10 days.
  • Haemodynamic instability.
  • Participation in other clinical trial for PE treatment during the present clinical trial.
  • Inability to use mask or nasal prongs.
  • Life expectancy less than 90 days.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Hospital Universitario Araba

Vitoria-Gasteiz, Alava, Spain

Location

Hospital Galdakao-Usansolo

Galdakao, Vizcaya, Spain

Location

Hospital Clínic de Barcelona

Barcelona, Spain

Location

Clínica Universidad de Navarra

Madrid, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, Spain

Location

Hospital Universitario y Politécnico La Fe

Valencia, Spain

Location

Related Publications (1)

  • Barrios D, Duran D, Rodriguez C, Moises J, Retegui A, Lobo JL, Lopez R, Chasco L, Jara-Palomares L, Muriel A, Otero-Candelera R, Ruiz-Artacho P, Monreal M, Bikdeli B, Jimenez D; Air vs Oxygen for Intermediate-Risk Pulmonary Embolism Investigators. Oxygen Therapy in Patients With Intermediate-Risk Acute Pulmonary Embolism: A Randomized Trial. Chest. 2024 Mar;165(3):673-681. doi: 10.1016/j.chest.2023.09.007. Epub 2023 Sep 16.

    PMID: 37717936DERIVED

MeSH Terms

Conditions

Pulmonary Embolism

Interventions

nitrox

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • David Jiménez

    IRYCIS, Alcala de Henares University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pulmonary physician

Study Record Dates

First Submitted

June 27, 2019

First Posted

July 1, 2019

Study Start

July 11, 2019

Primary Completion

April 24, 2022

Study Completion

July 25, 2022

Last Updated

August 18, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

ES(7)