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NCT01727427 · ClinicalTrials.gov registry record
Prospective Study on the Treatment of Unsuspected Pulmonary Embolism in Cancer Patients
A clinical trial of Unsuspected Pulmonary Embolism, sponsored by G. d'Annunzio University.
- Completed
- Registry status
- 695
- Enrollment target
- 20
- Study locations
NCT01727427: Completed study of Unsuspected Pulmonary Embolism, sponsored by G. d'Annunzio University.
NCT01727427 is a study of Unsuspected Pulmonary Embolism that has completed, run by G. d'Annunzio University. The registered enrollment target is 695 participants. The trial reports 20 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01727427, a study of Unsuspected Pulmonary Embolism, has completed, sponsored by G. d'Annunzio University.
- COMPLETED
- Registry status
- 695 participants
- Enrollment target
- 20
- Study locations
Study Summary
The same initial and long-term anticoagulation is suggested for unsuspected pulmonary embolism as for patients with symptomatic embolism. Based on these indications, cancer patients with unsuspected pulmonary embolism would be anticoagulated for at least 6 months or until the disease is active, which in most cases would mean indefinite treatment. In fact, dedicated studies on the treatment of unsuspected pulmonary embolism are missing, leaving doubts over the need for (indefinite) anticoagulation which exposes these patients to an increased risk of major bleeding events. Concerns over the need for anticoagulant treatment may especially hold for pulmonary embolism of the distal pulmonary tree since segmental and sub-segmental PE seem to have a more benign course than more proximal embolism. The scope of this study is to evaluate the current treatment approaches for unsuspected pulmonary embolism and to assess their efficacy and safety in a large prospective cohort of cancer patients.
Primary Outcome
Suspected recurrent PE with one of the following: 1. new intra-luminal filling defect on CT scan, MRI scan, or pulmonary angiogram; 2. new perfusion defect of at least 75% on V/Q lung scan; 3. inconclusive spiral CT, pulmonary angiography or lung scan with demonstration of DVT in the lower extremities by CUS or venography Fatal PE is: 1. PE based on objective diagnostic testing or autopsy or 2. death not attributed to a documented cause and for which DVT/PE cannot be ruled out. Suspected (re
Conditions Studied
Interventions
- DRUG Heparin, fondaparinux, vitamin-K antagonists, aspirin
Study Locations (20)
Other
- Clinical Division of Haematology, Department of Medicine I - Vienna
- Division of Hematology, University of Ottawa - Ottawa
- CHU Amiens Picardie - Amiens
- Arras/Onco Nord Pas de Callais, Loos - Arras
- Hopital Saint André - Bordeaux
- Brest HIA Clermont Tonnerre - Brest
- University hospital Centra La Cavale Blanche - Brest
- Montpellier et clinique du parc a Castelnau le nez - Castelnau
- Hopital G. Montpied Clermont-Ferrand - Clermont
- AP-HP Hopital Louis Mourier - Colombes
- Laboratoire d'Hématologie, Dijon - Dijon
- CHU de Limoges - Limoges
- Centre Hospitalier Lyon-Sud - Lyon
- Hopital Europeen Georges Pompidou - Paris
- Hopital Loriboisière - Paris
- Hospital Pitie Salpetriere - Paris
- Service de médecine et Thérapeutique - Saint-Etienne
- Division of Vascular Medicine, Department of Medicine, Technical University Dresden - Dresden
- Ospedali Riuniti - Bergamo
District of Columbia
- D.C. Veterans Affairs Medical Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 695 participants |
| Start Date | 2012-11 |
| Est. Completion | 2017-12 |
What the finished NCT01727427 record still lists
NCT01727427 is an observational study that tracks outcomes without assigning an intervention. The registered 695 participants enrollment target is mid-sized for trials with a published cap.
The record links to 1 condition, with Unsuspected Pulmonary Embolism appearing as the primary indexed condition, and to 1 intervention - of which Heparin, fondaparinux, vitamin-K antagonists, aspirin is the first listed.
NCT01727427 names 20 study sites across 2 states, led by Other, District of Columbia.
Frequently Asked Questions
What is clinical trial NCT01727427 about?
NCT01727427 is a clinical study titled "Prospective Study on the Treatment of Unsuspected Pulmonary Embolism in Cancer Patients". The same initial and long-term anticoagulation is suggested for unsuspected pulmonary embolism as for patients with symptomatic embolism. Based on these indications, cancer patients with unsuspected pulmonary embolism would be anticoagulated for at least 6 months or until the disease is active, whic...
What is the current status of trial NCT01727427?
This trial is currently completed. The enrollment target is 695 participants. The study started on 2012-11. Estimated completion is 2017-12.
What conditions does trial NCT01727427 study?
This clinical trial studies the following conditions: Unsuspected Pulmonary Embolism.
What interventions are being tested in trial NCT01727427?
The interventions under investigation include: Heparin, fondaparinux, vitamin-K antagonists, aspirin (DRUG).
Who is sponsoring clinical trial NCT01727427?
This trial is sponsored by G. d'Annunzio University, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01727427 being conducted?
This trial has 20 study locations across District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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