Pulmonary EmbolismNCT02388841
Thrombus Localization and Accompaying Disorders and Risk Factors
An observational study of Pulmonary Embolism, run by Aysel Sünnetçioğlu at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 81 years
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- Pulmonary embolism
- Type of treatment
- Surgery or procedure
- How many people
- 148 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2012to Aug 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 81 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Pulmonary embolism Computed tomographic pulmonary angiography Red cell distribution width
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Yuzuncu Yil University Hospital
Van, Tuşba, 65080
About this study
Official title: Assessment of the Association Between Thrombus Localization and Accompaying Disorders ,Rısk Factors, D-Dimer and Red Cells Distribution Witdh In Pulmonary Embolisim
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.
Read the detailed description
Background 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.
Material/Methods In 148 patients diagnosed with pulmonary embolism, the presence and anatomical localization of the thrombus were assessed with Computed tomographic pulmonary angiography. The accompanying disorders, risk factors, serum D-dimer, and the RDW in the patients were retrospectively evaluated.
Background Pulmonary embolism (PE) is a serious cardiopulmonary disorder caused by partial or complete obstruction of the pulmonary arterial bed by a thrombus formed in systemic veins. Pulmonary embolism is thought to be a result of the interaction between the patient and risk factors 1-3. In case of suspected PE, clinical, laboratory, and radiological findings should be carefully studied. Since the clinical findings in PE are non-specific, objective diagnostic tests are required for the diagnosis 4. Computed tomographic pulmonary angiography (CTPA) is increasingly being used as the first investigation for suspected PE. The extent of PE is commonly expressed by indicating the anatomical level of the most proximal vessel affected by a thrombus 5. For the definite diagnosis of suspected PE, one of the tests to be used is the determination of the D-dimer level. Plasma D-dimer measurement provides information about fibrin-degradation fragment following fibrinolysis. D-dimer assays have low specificity, but high sensitivity and negative predictive value in most patients with suspected thromboembolism 6. The red cell distribution width (RDW) is a quantitative indicator of the size variability of red blood cells. This parameter can be easily obtained from a full blood count and is accepted as an indicator of ineffective red cell production 7. Some studies have suggested that RDW may be associated with cardiovascular and pulmonary diseases including PE 8-13.
The purpose of this study was to determine the association between thrombus localization and risk factors, accompanying disorders, D-dimer and red blood cell distribution width (RDW) in patients with pulmonary embolism.
Material and Methods Study design 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.
Computed tomographic pulmonary angiography A thoracic CT scan was performed using a 16-detector multi-sectional CT scanner (Somatom Emotion 16-slice; CT2012E-Siemens AG, Berlin and München-Germany) by injecting contrast agents intravenously, while the patient held her breath. Contrast-enhanced images were obtained 50-70 sec after IV administration of 120 ml of ionic iodinated contrast agent, iodiksanol (Visipaque 320 mg/100 ml, Opakim) using a power injector at a rate of 2 ml/sec.
The parameters used were 120-130 (Kv), 80-120 (Ef-Mass), 0.6 sec (rotation time), 16 mm×1.2 mm (acquisition), 1.2 mm (slice collimation), 5.0-3.0 (slice width), 0.80 (pitch factor), 5.0 mm (increment), and 512×512 (matrix).
D-dimer test The patients' blood specimens were evaluated in the Clinical Hematology Laboratory. The D-dimer levels were measured with a latex-enhanced photometric method ( Sta compact, Dade Behring, Marburg, Germany) using D-dimer kits.
Red blood cell distribution width (RDW) The red cell distribution width (RDW) was determined in whole blood specimens. The hematological analysis was performed with a Coulter LH 750 Complete Blood Count device (Beckman Coulter, Fullerton, California, USA).
The study was planned according to the Declaration of Helsinki and rules of the Hospital Ethics Committee.
Statistical analysis Descriptive statistics were presented with frequency and percent for categorical data, and with mean and standard deviation for numerical data. Comparisons between 2 independent groups were conducted with Mann-Whitney U test, and Chi-Square test for non-normally distributed numerical, and categorical variables, respectively. Pairwise Pearson correlation was executed to estimate linear relationship between characteristics. Receiver operating characteristic (ROC) curve analysis was utilized to determine the optimum cutoff level of the association of RDW with MPA. All statistical calculations were performed using SAS version 9.3 (SAS, 2014). The results were considered statistically significant when the p value was <0.05.
- Conditions
- Pulmonary Embolism
- Being tested
- Pulmonary embolism
- Keywords
- Pulmonary embolism, Computed tomographic pulmonary
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary embolismRadiation
Also called Red cell distribution width
the thrombus were assessed with Computed tomographic pulmonary angiography
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary embolism | Distribution of the characteristics of Pulmonary Embolism patients according to thrombus localization Receives: 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 Receives: Radiation: Pulmonary embolism |
What is being measured
The primary outcome is the main question the study is designed to answer.
association between thrombus localization and risk factors, accompanying disorders, D-dimer and red blood cell distribution width (RDW) in patients with pulmonary embolism.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startJan 2012
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aysel Sünnetçioğlu
- Sponsor type
- University, hospital or other
- Collaborators
- Yuzuncu Yil University
- Responsible party
- Sponsor-investigator, Aysel Sünnetçioğlu, Yuzuncu Yil University
- Investigators
- aysel sunnetcioglu, PHD, Study director, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02388841
- Sponsor's protocol ID
- YYU-015
- Other IDs
- YYU-2015-65
- Status last verified
- Mar 2015
- First submitted
- 3 Mar 2015
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26106964
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Association Between Thrombus Localization and Accompaying Disorders ,Rısk Factors, D-Dimer and Red Cells Distribution Witdh In Pulmonary Embolisim
- ClinicalTrials.gov ID
- NCT02388841
- Acronym / sponsor ID
- YYU-015
- Conditions
- Pulmonary Embolism
- Keywords
- Pulmonary embolism, Computed tomographic pulmonary
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Aysel SünnetçioğluUniversity, hospital or other
- Collaborators
- Yuzuncu Yil University
- Study start
- Jan 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 17 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background 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.
Material/Methods In 148 patients diagnosed with pulmonary embolism, the presence and anatomical localization of the thrombus were assessed with Computed tomographic pulmonary angiography. The accompanying disorders, risk factors, serum D-dimer, and the RDW in the patients were retrospectively evaluated.
Background Pulmonary embolism (PE) is a serious cardiopulmonary disorder caused by partial or complete obstruction of the pulmonary arterial bed by a thrombus formed in systemic veins. Pulmonary embolism is thought to be a result of the interaction between the patient and risk factors 1-3. In case of suspected PE, clinical, laboratory, and radiological findings should be carefully studied. Since the clinical findings in PE are non-specific, objective diagnostic tests are required for the diagnosis 4. Computed tomographic pulmonary angiography (CTPA) is increasingly being used as the first investigation for suspected PE. The extent of PE is commonly expressed by indicating the anatomical level of the most proximal vessel affected by a thrombus 5. For the definite diagnosis of suspected PE, one of the tests to be used is the determination of the D-dimer level. Plasma D-dimer measurement provides information about fibrin-degradation fragment following fibrinolysis. D-dimer assays have low specificity, but high sensitivity and negative predictive value in most patients with suspected thromboembolism 6. The red cell distribution width (RDW) is a quantitative indicator of the size variability of red blood cells. This parameter can be easily obtained from a full blood count and is accepted as an indicator of ineffective red cell production 7. Some studies have suggested that RDW may be associated with cardiovascular and pulmonary diseases including PE 8-13.
The purpose of this study was to determine the association between thrombus localization and risk factors, accompanying disorders, D-dimer and red blood cell distribution width (RDW) in patients with pulmonary embolism.
Material and Methods Study design 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.
Computed tomographic pulmonary angiography A thoracic CT scan was performed using a 16-detector multi-sectional CT scanner (Somatom Emotion 16-slice; CT2012E-Siemens AG, Berlin and München-Germany) by injecting contrast agents intravenously, while the patient held her breath. Contrast-enhanced images were obtained 50-70 sec after IV administration of 120 ml of ionic iodinated contrast agent, iodiksanol (Visipaque 320 mg/100 ml, Opakim) using a power injector at a rate of 2 ml/sec.
The parameters used were 120-130 (Kv), 80-120 (Ef-Mass), 0.6 sec (rotation time), 16 mm×1.2 mm (acquisition), 1.2 mm (slice collimation), 5.0-3.0 (slice width), 0.80 (pitch factor), 5.0 mm (increment), and 512×512 (matrix).
D-dimer test The patients' blood specimens were evaluated in the Clinical Hematology Laboratory. The D-dimer levels were measured with a latex-enhanced photometric method ( Sta compact, Dade Behring, Marburg, Germany) using D-dimer kits.
Red blood cell distribution width (RDW) The red cell distribution width (RDW) was determined in whole blood specimens. The hematological analysis was performed with a Coulter LH 750 Complete Blood Count device (Beckman Coulter, Fullerton, California, USA).
The study was planned according to the Declaration of Helsinki and rules of the Hospital Ethics Committee.
Statistical analysis Descriptive statistics were presented with frequency and percent for categorical data, and with mean and standard deviation for numerical data. Comparisons between 2 independent groups were conducted with Mann-Whitney U test, and Chi-Square test for non-normally distributed numerical, and categorical variables, respectively. Pairwise Pearson correlation was executed to estimate linear relationship between characteristics. Receiver operating characteristic (ROC) curve analysis was utilized to determine the optimum cutoff level of the association of RDW with MPA. All statistical calculations were performed using SAS version 9.3 (SAS, 2014). The results were considered statistically significant when the p value was <0.05.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulmonary embolism | – | Radiation: Pulmonary embolismDistribution of the characteristics of Pulmonary Embolism patients according to thrombus localization |
| tomographic pulmonary angiography | – | Radiation: Pulmonary embolismDistribution 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 |
Who may qualify
- Ages
- 18 to 81 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Pulmonary embolism Computed tomographic pulmonary angiography Red cell distribution width
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary embolismAlso: Red cell distribution widththe thrombus were assessed with Computed tomographic pulmonary angiography | Radiation | Pulmonary embolism, tomographic pulmonary angiography |
Primary outcome
association between thrombus localization and risk factors, accompanying disorders, D-dimer and red blood cell distribution width (RDW) in patients with pulmonary embolism.
Time frame: up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2015.
- Derived from this study: PubMed 26106964Sunnetcioglu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
aysel sunnetcioglu, PHD study director
Yuzuncu Yil University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Embolism, run by Aysel Sünnetçioğlu at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
association between thrombus localization and risk factors, accompanying disorders, D-dimer and red blood cell distribution width (RDW) in patients with pulmonary embolism. (time frame: up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02388841, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2015.