NCT02388841

Brief Summary

ABSTRACT Pulmonary embolism shows a wide spectrum ranging from clinically asymptomatic thrombus to massive thrombus, leading to cardiogenic shock. The purpose of this study was to determine the association between thrombus localization and risk factors, accompanying disorders, D-dimer and the red blood cell distribution width (RDW) in patients with pulmonary embolism.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 17, 2015

Completed
Last Updated

March 17, 2015

Status Verified

March 1, 2015

Enrollment Period

2.6 years

First QC Date

March 3, 2015

Last Update Submit

March 15, 2015

Conditions

Keywords

Pulmonary embolism, Computed tomographic pulmonary

Outcome Measures

Primary Outcomes (1)

  • association between thrombus localization and risk factors, accompanying disorders, D-dimer and red blood cell distribution width (RDW) in patients with pulmonary embolism.

    up to 24 months

Study Arms (2)

Pulmonary embolism

Distribution of the characteristics of Pulmonary Embolism patients according to thrombus localization

Radiation: Pulmonary embolism

tomographic pulmonary angiography

Distribution of the characteristics of Pulmonary Embolism patients according to the localization of thrombi in the most proximal level of Main pulmonary artery and other arterial branches as confirmed by Computed tomographic pulmonary angiography

Radiation: Pulmonary embolism

Interventions

the thrombus were assessed with Computed tomographic pulmonary angiography

Also known as: Red cell distribution width
Pulmonary embolismtomographic pulmonary angiography

Eligibility Criteria

Age18 Years - 81 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The data confirmed on 148 patients having PE by CTPA in the Clinic of Chest Diseases, Medical School, Yüzüncü Yıl University, Van, Turkey, in the period between January 2012 and August 2014 were retrospectively studied. The patients' accompanying disorders, risk factors, and the dosing of D-dimer performed on the same day of the CTPA and RDW levels were noted. The patients who had a story of hospitalising for reasons other than surgery such as Pneumonia, apses, brucella, encephalitis and the bedridden patients such as hemiplegia and long-term immobilised patients (\>72 hours) after surgery were listed in the immobilisation group. Patients receiving the diagnosis of PE with no CTPA performed and 6 patients whose haemoglobin values were below 11 were not included in this study.

You may qualify if:

  • \- Pulmonary embolism Computed tomographic pulmonary angiography Red cell distribution width

You may not qualify if:

  • \- Patients receiving the diagnosis of PE with no CTPA performed and 6 patients whose haemoglobin values were below 11 were not included in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yuzuncu Yil University Hospital

Van, Tuşba, 65080, Turkey (Türkiye)

Location

Related Publications (1)

  • Sunnetcioglu A, Sertogullarindan B, Ozbay B, Asker S, Ekin S. Assessments of the associations of thrombus localization with accompanying disorders, risk factors, D-dimer levels, and the red cell distribution width in pulmonary embolism. Clinics (Sao Paulo). 2015 Jun;70(6):441-5. doi: 10.6061/clinics/2015(06)10. Epub 2015 Jun 1.

MeSH Terms

Conditions

Pulmonary Embolism

Interventions

Erythrocyte Indices

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Hematologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesBlood Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • aysel sunnetcioglu, PHD

    Yuzuncu Yil University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Department of Pulmory Diseas Aysel Sünnetçioğlu

Study Record Dates

First Submitted

March 3, 2015

First Posted

March 17, 2015

Study Start

January 1, 2012

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

March 17, 2015

Record last verified: 2015-03

Locations