Epoprostenol in Pulmonary Embolism

This study has been completed.
Sponsor:
Information provided by:
Free University Medical Center
ClinicalTrials.gov Identifier:
NCT01014156
First received: November 13, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

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


Condition Intervention Phase
Acute Pulmonary Embolism
Drug: epoprostenol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Intravenous Epoprostenol Sodium (Flolan®) in Patients With Moderate-to-Severe Pulmonary Thrombo-Embolism

Resource links provided by NLM:


Further study details as provided by Free University Medical Center:

Primary Outcome Measures:
  • Right ventricular end diastolic diameter (ultrasound) [ Time Frame: 0, 2,5 4, 24 and 72 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • systolic pulmonary artery pressure (ultrasound) [ Time Frame: identical to primary measure ] [ Designated as safety issue: Yes ]

Enrollment: 14
Study Start Date: January 2004
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: epoprostenol intraveneously
epoprostenol iv versus placebo iv, both on top of low molecular weight heparin
Drug: epoprostenol
titration up to 4 ng/kg/min
Other Name: prostacyclin, flolan

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01014156

Locations
Netherlands
Free University Medical Center
Amsterdam, Netherlands, 1081 HV
Sponsors and Collaborators
Free University Medical Center
  More Information

No publications provided by Free University Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Albertus Jozef Kooter, Free University Medical Center
ClinicalTrials.gov Identifier: NCT01014156     History of Changes
Other Study ID Numbers: 03.123
Study First Received: November 13, 2009
Last Updated: November 13, 2009
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Free University Medical Center:
pulmonary embolism
vasoconstriction
right ventricular dysfunction
epoprostenol
acute pulmonary embolism with right ventricular dysfunction

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 19, 2014