Pulmonary embolism landmark trials


 * Associate Editor-In-Chief: Ujjwal Rastogi, MBBS [mailto:urastogi@perfuse.org]

Trials assessing the diagnosis
1. PIOPED (Prospective Investigation in Pulmonary Embolism Diagnosis) (1989).

(ClinicalTrials.gov number, NCT00000566).
 * Purpose : To evaluate the sensitivity and specificity of two major, widely used technologies, radionuclear imaging (ventilation-perfusion scanning) and pulmonary angiography, for the diagnosis of pulmonary embolism.
 * Study Type: Interventional
 * Study Design: Primary Purpose: Diagnostic

2. PIOPED II (Prospective Investigation in Pulmonary Embolism Diagnosis II) (2002).

(ClinicalTrials.gov number, NCT00007085).
 * Purpose : It was designed to assess the efficacy of the spiral computed tomographic pulmonary angiogram in patients suspected of having acute pulmonary embolism (PE).
 * Study Type:  Interventional
 * Study Design: Primary Purpose: Diagnostic
 * Comparison with PIOPED: In contrast to the original PIOPED study, which used contrast pulmonary angiography as the primary reference test for PE, PIOPED II used composite reference test for venous thromboembolism that was based on the ventilation/perfusion lung scan, venous compression ultrasound of the lower extremities, digital subtraction pulmonary angiography, and contrast venography in various combinations to establish the PE status of the patient. New criteria for ventilation/perfusion lung scan diagnosis were developed for PIOPED II.

3. PIOPED III (Prospective Investigation of Pulmonary Embolism Diagnosis III) (2010).

(ClinicalTrials.gov number, NCT00241826).
 * Purpose :The purpose of this study is to determine the diagnostic accuracy of gadolinium-enhanced magnetic resonance angiography (Gd-MRA) of the pulmonary arteries in combination with magnetic resonance venography (MRV) of the veins of the thighs in patients with clinically suspected acute pulmonary embolism (PE).'''
 * Study Type: Observational
 * Study Design: Observational Model:Cohort, Time Perspective:Prospective.

Trials assessing the efficacy of LMWH in reducing mortality in acutely ill patients
1. LIFENOX (Study to Evaluate the Mortality Reduction of Enoxaparin in Hospitalized Acutely Ill Medical Receiving Enoxaparin) (2011).

(ClinicalTrials.gov number, NCT00622648).
 * Study Type:  Interventional
 * Study Design: Primary Purpose: Treatment, Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator).
 * Conclusion: Enoxaparin plus elastic stockings with graduated compression, failed to show any reduction in the rate of death from any cause among hospitalized, acutely ill medical patients, when compared to elastic stockings with graduated compression alone.

Study assessing the efficacy of Thrombolysis
1. MAPPET (Management Strategy and Prognosis of Pulmonary Embolism Registry) (1997).

Study assessing the factors causing death
1. ICOPER (International Cooperative Pulmonary Embolism Registry) (1999).