NCT00565253

Brief Summary

The purpose of the study is to determine if inhaled nitric oxide, a potent and selective pulmonary vasodilator, is beneficial in patients with acute pulmonary embolism causing increased right ventricular afterload.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2005

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

March 1, 2005

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 29, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

June 23, 2010

Status Verified

June 1, 2010

Enrollment Period

4.3 years

First QC Date

November 28, 2007

Last Update Submit

June 22, 2010

Conditions

Pulmonary Embolism

Keywords

pulmonary embolisminhaled nitric oxide

Outcome Measures

Primary Outcomes (1)

  • right ventricular size and arterial oxygenation

    2 hours

Secondary Outcomes (1)

  • blood pressure, central venous pressure, right ventricular function, pulmonary artery pressure

    2 hours

Interventions

Inhaled nitric oxide (NO)DRUG

20 ppm for 15 minutes

Eligibility Criteria

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

You may qualify if:

  • Patients with acute pulmonary embolism within 24 hours after onset of symptoms.
  • Patients with hypoxaemia not present before pulmonary embolism and acute right ventricular dysfunction.

You may not qualify if:

  • Age \< 18 years.
  • Chronic lung disease, left heart failure, suspected or documented intracranial bleeding.
  • Pregnancy, Methaemoglobinaemia.
  • Patients who previously needed thrombolysis or surgical embolectomy.
  • Negative D-Dimer test.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Emergency Medicine, Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (1)

  • Capellier G, Jacques T, Balvay P, Blasco G, Belle E, Barale F. Inhaled nitric oxide in patients with pulmonary embolism. Intensive Care Med. 1997 Oct;23(10):1089-92. doi: 10.1007/s001340050461.

    PMID: 9407246BACKGROUND

Related Links

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Peter Schenk, Prof MD MSc

    Dpt. of Internal Medicine III, Medical University Vienna, Austria

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 28, 2007

First Posted

November 29, 2007

Study Start

March 1, 2005

Primary Completion

July 1, 2009

Study Completion

December 1, 2009

Last Updated

June 23, 2010

Record last verified: 2010-06

Locations

AU(1)