Advertisement

Topics

Arixtra PE Study- Outpatient Management of Stable Acute Pulmonary Embolism: Once Daily Subcutaneous Fondaparinux

2014-08-27 03:42:28 | BioPortfolio

Summary

To assess the safety and efficacy of outpatient treatment using fondaparinux and oral Vit K antagonist, warfarin (Coumadin) in patients with stable acute pulmonary embolus (APE)when initial therapy is administered in the hospital. Prospectively validate risk stratification criteria for predicting patient suitability for outpatient treatment of acute pulmonary embolism.

Description

The current standard therapy for Acute Pulmonary Embolism (APE) involves admitting patients to the hospital for administration of parenteral anticoagulation therapy(Unfractionated Heparin, Low Molecular Weight Heparin, or Fondaparinux) as a bridge to oral Vitamin K Antagonists (warfarin{Coumadin}). There is a group of patients who are low risk for adverse events and thus may be amenable to outpatient management. Newly identified cardio-specific biomarkers, such as cardiac troponins (TNT and cTnI) and brain natriuretic peptide (BNP) offer added diagnostic information that has been shown to help risk stratify patients presenting with APE. Use of the biomarkers could help separate low- from high-risk subjects, particularly the subgroup of patients who, despite hemodynamic stability at presentation, carry the highest risk of adverse events. Once a low risk APE group is identified, a less complex and less resource-intensive but equally efficacious and safe treatment which allows earlier discharge would be desirable. The current reference therapy is intravenous unfractionated heparin (UFH) for initial anticoagulation for a minimum of 4-5 days of overlap and until therapeutic INR is achieved. Although low-molecular weight heparins (LMWH) have been widely used for DVT treatment, their use for patients with APE is limited to inpatient administration. Fondaparinux sodium (Arixtra) is a synthetic and specific inhibitor of activated Factor X(Xa). Several studies have shown that fondaparinux was more effective than enoxaparin when used as a venous thromboembolism (VTE) prophylaxis agent. Additionally, in the published literature to date, there are no reported cases of heparin-induced thrombocytopenia (HIT) syndrome proven to be caused by fondaparinux. Fondaparinux is approved by the Food and Drug Administration (FDA) for the treatment of acute pulmonary embolism when administered in conjunction with warfarin sodium when initial therapy is administered in the hospital. By means of a non-randomized, open label pilot study, we seek to prospectively assess the safety and efficacy of outpatient treatment using fondaparinux and oral Vitamin K antagonists (warfarin) in patients with stable acute pulmonary embolus and validate risk stratification criteria for predicting patient suitability for outpatient therapy of acute pulmonary embolism.

Study Design

Time Perspective: Prospective

Conditions

Pulmonary Embolism

Location

Cleveland Clinic 9500 Euclid Ave.
Cleveland
Ohio
United States
44195

Status

Terminated

Source

The Cleveland Clinic

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:42:28-0400

Clinical Trials [1081 Associated Clinical Trials listed on BioPortfolio]

PEITHO Pulmonary Embolism Thrombolysis Study

Heparin is the reference therapy for most patients with pulmonary embolism. Some patients with sub-massive pulmonary embolism defined by normal blood pressure and dysfunction of the right ...

Pulmonary Rehabilitation to Improve Physical Capacity After Pulmonary Embolism

This project aims to evaluate a rehabilitation program as treatment and uncover potential pathophysiological mechanisms of a newly identified chronic condition named "Post Pulmonary Emboli...

Study of Diagnosis and Pathophysiology of Pulmonary Embolism (APE 1 Trial)

The purpose of this study is to - investigate which method and criterion for diagnosing pulmonary embolism is the best and - determine the relationship between blood ves...

Identifying Low-Risk Patients With Pulmonary Embolism

To develop a clinical prediction rule to identify patients with acute pulmonary embolism who are at very low risk for short-term adverse outcomes.

D-dimer Testing Tailored to Clinical Pretest Probability in Suspected Pulmonary Embolism

Prospective, multicentre, cohort study assessing a diagnostic management strategy for suspected Pulmonary Embolism with independent central adjudication of outcomes

PubMed Articles [2555 Associated PubMed Articles listed on BioPortfolio]

Identification of haptoglobin as a potential diagnostic biomarker of acute pulmonary embolism.

: Acute pulmonary embolism is a common disease, which is associated with high mortality and morbidity. There is significant relationship between haptoglobin and pulmonary embolism, however, the useful...

Pulmonary embolism rule-out criteria (PERC) rule in European patients with low implicit clinical probability (PERCEPIC): a multicentre, prospective, observational study.

The ability of the pulmonary embolism rule-out criteria (PERC) to exclude pulmonary embolism without further testing remains debated outside the USA, especially in the population with suspected pulmon...

Combination of Pulmonary Embolism Rule-out Criteria and YEARS Algorithm in a European Cohort of Patients with Suspected Pulmonary Embolism.

 Both the YEARS algorithm and the pulmonary embolism (PE) rule-out criteria (PERC) were created to exclude PE with limited diagnostic tests. A diagnostic strategy combining both scores might save ad...

Pediatric In-Hospital Cardiac Arrest Secondary to Acute Pulmonary Embolism.

Pulmonary embolism is a rarely reported and potentially treatable cause of cardiac arrest in children and adolescents. The objective of this case series is to describe the course of five adolescent pa...

Cardiopulmonary Exercise Testing in Patients Following Massive and Submassive Pulmonary Embolism.

Little data exist regarding the functional capacity of patients following acute pulmonary embolism. We sought to characterize the natural history of symptom burden, right ventricular (RV) structure an...

Medical and Biotech [MESH] Definitions

Hypertrophy and dilation of the RIGHT VENTRICLE of the heart that is caused by PULMONARY HYPERTENSION. This condition is often associated with pulmonary parenchymal or vascular diseases, such as CHRONIC OBSTRUCTIVE PULMONARY DISEASE and PULMONARY EMBOLISM.

Blocking of the PULMONARY ARTERY or one of its branches by an EMBOLUS.

An anticoagulant that acts by inhibiting the synthesis of vitamin K-dependent coagulation factors. Warfarin is indicated for the prophylaxis and/or treatment of venous thrombosis and its extension, pulmonary embolism, and atrial fibrillation with embolization. It is also used as an adjunct in the prophylaxis of systemic embolism after myocardial infarction. Warfarin is also used as a rodenticide.

Respiratory syndrome characterized by the appearance of a new pulmonary infiltrate on chest x-ray, accompanied by symptoms of fever, cough, chest pain, tachypnea, or DYSPNEA, often seen in patients with SICKLE CELL ANEMIA. Multiple factors (e.g., infection, and pulmonary FAT EMBOLISM) may contribute to the development of the syndrome.

Excessive accumulation of extravascular fluid in the lung, an indication of a serious underlying disease or disorder. Pulmonary edema prevents efficient PULMONARY GAS EXCHANGE in the PULMONARY ALVEOLI, and can be life-threatening.

More From BioPortfolio on "Arixtra PE Study- Outpatient Management of Stable Acute Pulmonary Embolism: Once Daily Subcutaneous Fondaparinux"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topic

Pulmonary
Pulmonary relating to or associated with the lungs eg Asthma, chronic bronchitis, emphysema, COPD, Cystic Fibrosis, Influenza,  Lung Cancer, Pneumonia, Pulmonary Arterial Hypertension, Sleep Disorders etc Follow and track Lung Cancer News ...


Searches Linking to this Trial