Epoprostenol in Pulmonary Embolism

Acute Pulmonary Embolism Clinical Trial

Official title:

Effects of Intravenous Epoprostenol Sodium (Flolan®) in Patients With Moderate-to-Severe Pulmonary Thrombo-Embolism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01014156
• Other study ID #: 03.123
• Status: Completed
• Phase: Phase 4
• First received: November 13, 2009
• Last updated: November 13, 2009
• Start date: January 2004
• Est. completion date: June 2006

Study information

• Verified date: November 2009
• Source: Free University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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

Description:

Pulmonary thromboembolism (PE) with circulatory and/or respiratory symptoms is associated with high morbidity and mortality. Acute pulmonary hypertension is the hallmark of severe PE, and is to be held responsible for the full spectrum of clinical manifestations and complications. Although it is common belief that only mechanical obstruction by thrombus mass causes this pulmonary hypertension, there is strong evidence indicating that pulmonary vasoconstriction contributes significantly to the rise in pulmonary vascular resistance.

Although all patients will receive anticoagulant treatment immediately after the diagnosis is established, morbidity and mortality are still disturbingly high when circulatory and/or respiratory symptoms accompany PE, or when hemodynamically stable PE patients have echocardiographic signs of acute right ventricle overload. There are no generally accepted guidelines for additional treatment options in these patients with moderate-to-severe PE. Thrombolytic therapy is recommended by many when hemodynamic symptoms are severe, but its effectiveness has never been proven in a controlled trial. In patients with moderate-to-large PE associated with echocardiographic signs of right ventricle overload, but who are still circulatory stable, mortality is increased, but thrombolytic therapy appears not to be beneficial.

Given the plausible role of pulmonary vasoconstriction in the pathogenesis of PE associated pulmonary hypertension, the potential benefit of pulmonary vasodilators is important.There is experimental evidence that antagonising pulmonary vasoconstriction by the administration of selective vasodilators may be beneficial in animals with PE. In addition, anecdotal evidence of a similar kind exists for humans with acute PE.

We hypothesise that in PE patients who have echocardiographic evidence of acute right ventricle overload, epoprostenol sodium (Flolan®) results in partial or complete reversal of echocardiographic abnormalities, as well as in improvement in respiratory and circulatory symptoms and signs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• acute (symptoms <24 hrs) with right ventricular dilatation (>30 mm end diastolic, systolic PAP > 50 mmHg,

• absence of right ventricular wall hypertrophy)

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Pulmonary Embolism
• Embolism
• Pulmonary Embolism

Intervention

Drug:
• epoprostenol
titration up to 4 ng/kg/min

Locations

Country	Name	City	State
Netherlands	Free University Medical Center	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Free University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Right ventricular end diastolic diameter (ultrasound)		0, 2,5 4, 24 and 72 hours	Yes
Secondary	systolic pulmonary artery pressure (ultrasound)		identical to primary measure	Yes