Epoprostenol in Pulmonary Embolism
Effects of Intravenous Epoprostenol Sodium (Flolan®) in Patients With Moderate-to-Severe Pulmonary Thrombo-Embolism
1 other identifier
interventional
14
1 country
1
Brief Summary
You are admitted to hospital because of pulmonary embolism. You are treated with anticoagulants. The investigators know that, despite this treatment, pulmonary embolism can be a threat especially if heart function is compromized. The investigators investigate a well known study drug (epoprostenol) on top of regular treatment with anticoagulants, to see if heart function can be optimized
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jan 2004
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 13, 2009
CompletedFirst Posted
Study publicly available on registry
November 16, 2009
CompletedNovember 16, 2009
November 1, 2009
2.4 years
November 13, 2009
November 13, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Right ventricular end diastolic diameter (ultrasound)
0, 2,5 4, 24 and 72 hours
Secondary Outcomes (1)
systolic pulmonary artery pressure (ultrasound)
identical to primary measure
Study Arms (1)
epoprostenol intraveneously
EXPERIMENTALepoprostenol iv versus placebo iv, both on top of low molecular weight heparin
Interventions
titration up to 4 ng/kg/min
Eligibility Criteria
You may qualify if:
- acute (symptoms \<24 hrs) with right ventricular dilatation (\>30 mm end diastolic, systolic PAP \> 50 mmHg,
- absence of right ventricular wall hypertrophy)
You may not qualify if:
- age below 18 years or above 70 years
- body mass index \>35 kg/m2
- duration of symptoms \>24 hours (since onset or acute increase in symptoms)
- severe circulatory shock (systemic blood pressure systolic \<80 mmHg, or diastolic blood pressure \<45 mmHg) or respiratory failure, requiring mechanical ventilation.
- patients who, in the opinion of the supervising physician, require thrombolytic therapy.
- severe pre-existent cardiopulmonary disease (heart failure, obstructive pulmonary disease, emphysema)
- atrial fibrillation
- refusal or inability to give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Free University Medical Center
Amsterdam, 1081 HV, Netherlands
Related Publications (1)
Kooter AJ, Ijzerman RG, Kamp O, Boonstra AB, Smulders YM. No effect of epoprostenol on right ventricular diameter in patients with acute pulmonary embolism: a randomized controlled trial. BMC Pulm Med. 2010 Mar 30;10:18. doi: 10.1186/1471-2466-10-18.
PMID: 20353588DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 13, 2009
First Posted
November 16, 2009
Study Start
January 1, 2004
Primary Completion
June 1, 2006
Study Completion
June 1, 2006
Last Updated
November 16, 2009
Record last verified: 2009-11